xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06041854</url>
    </required_header>
    <id_info>
      <org_study_id>A02040122</org_study_id>
      <nct_id>NCT06041854</nct_id>
    </id_info>
    <brief_title>Allograft With Enamel Matrix Derivative Versus Allograft Alone in the Treatment of Intrabony Defects .</brief_title>
    <official_title>Comparison Between Allograft and Enamel Matrix Derivative and Allograft in Treatment of Intrabony Defects</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Mansoura University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Mansoura University</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Periodontal intrabony defects represent a major challenge for the clinician in periodontal&#xD;
        therapy. If left untreated, these defects represent a risk factor for disease progression and&#xD;
        additional attachment and bone loss.&#xD;
  &#xD;
        All patients will receive full mouth scaling and root planing and be re-evaluated to assess&#xD;
        patient cooperation and maintaining good oral hygiene. Subjects who showed persistent PPD ≥ 5&#xD;
        mm with radiographic evidence of periodontal intrabony defect presence will be included and&#xD;
        will be randomly allocated to one of two treatment groups.One group will be treated by&#xD;
        surgical treatment and the defects filled by freeze-dried bone allograft mixed with enamel&#xD;
        matrix derivative. second group will be treated by surgical treatment and the defects filled&#xD;
        by freeze-dried bone allograft .Clinical periodontal parameters (PI, GBI, PPD, CAL) will be&#xD;
        re-evaluated at 3, 6 and 9 months after surgery. CBCT will be taken after 9 months of surgery&#xD;
        and the defect measurements will be recorded&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        primary goal of periodontal therapy is not arrest the tissue destruction caused periodontal&#xD;
        disease only, but also to reconstruct the tissue lost caused by infectious process.&#xD;
        Periodontal intrabony defects represent a major challenge for the clinician in periodontal&#xD;
        therapy. If left untreated, these defects represent a risk factor for disease progression and&#xD;
        additional attachment and bone loss. Surgical intervention is considered the treatment of&#xD;
        choice for deep intrabony defects, which have not resolved following completion of&#xD;
        cause-related periodontal therapy.&#xD;
  &#xD;
        In general, periodontal studies showed that healing of periodontal defect after conventional&#xD;
        periodontal therapy by collagenous tissue with epithelial cell migration within the gingival&#xD;
        connective tissue and along the root surface. Therefore, a various of methods and techniques&#xD;
        used to prevent epithelial ingrowth to the defect site and permit only a selective&#xD;
        periodontal cells proliferation in attempt to regenerate periodontal tissues. Regenerative&#xD;
        procedures including the use of certain types of bone replacement materials, barrier&#xD;
        membranes, enamel matrix derivative (EMD), or various combinations thereof have been shown to&#xD;
        facilitate periodontal regeneration characterized histologically by formation of root&#xD;
        cementum, periodontal ligament, and alveolar bone and result superior in clinical, and&#xD;
        radiographical patient reported outcomes compared to access flap surgery alone.&#xD;
  &#xD;
        Various bone graft and bone substitutes materials can be helpful in the tissue restoration.&#xD;
        This bone graft include autogenous bone graft, allografts, xenografts, and alloplastic&#xD;
        materials. Autologous bone is considered the gold standard because of its biological activity&#xD;
        due to vital cells and growth factors. Yet, the autologous bone from intra-oral donor sites&#xD;
        is of restricted quantities and availability, and the bone tissue obtained from the iliac&#xD;
        crest is described to show faster resorption. Moreover, the harvesting of autologous bone&#xD;
        often requires a second surgical site associated with an additional bone defect, potential&#xD;
        donor site morbidity limiting their application.&#xD;
  &#xD;
        In recent years, the use of allogeneic human bone has been favored worldwide, and several&#xD;
        histological and morphological studies have demonstrated that, there is no difference in the&#xD;
        final stage of incorporation and new bone formation between allografts and autografts. Thus,&#xD;
        the application of processed allogenic bone tissue is a reliable and predictable alternative.&#xD;
  &#xD;
        Allogeneic bone graft refers to bony tissue that is harvested from one individual and&#xD;
        transplanted to a genetically different individual of the same species, principally&#xD;
        osteoconductive, although it may have some osteoinductive capability, depending on how it is&#xD;
        processed.&#xD;
  &#xD;
        Maxgraft® is allograft bone substitute processed by the Cells+Tissuebank Austria with a&#xD;
        special cleaning process (Allotec® process). The purification process keeps the structural&#xD;
        features and the interconnected macroporosity of human bone. It preserve natural bone&#xD;
        structure and collagen content, therefore it serves as a scaffold for natural bone&#xD;
        regeneration and has the potential of complete remodeling into patients' own bone. It is&#xD;
        available as purely cancellous as well as cortico-cancellous granules and blocks.&#xD;
  &#xD;
        Recently, better outcomes have been reported with a combination of xenograft and enamel&#xD;
        matrix derivative (EMD) as it combines the osteoconductive and space-making properties of&#xD;
        bone grafts with the ability of bioactive materials to stimulate periodontal regeneration.&#xD;
        The major components of EMD are amelogenins, a family of hydrophobic porcine tooth-derived&#xD;
        proteins. They account for more than 95% of the total EMD protein content. Other proteins&#xD;
        found in the enamel matrix include enamelin, ameloblastin, amelotin, apin and various&#xD;
        proteinases, which have found in trace amounts in EMD. EMD adsorbs on decontamined root&#xD;
        surfaces and alveolar bony defects and forms an insoluble scaffold complex.&#xD;
  &#xD;
        To the best of our knowledge, no previous studies have been performed for assessment of the&#xD;
        efficacy of using emdogain with maxgraft.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">November 22, 2022</start_date>
    <completion_date type="Anticipated">February 2024</completion_date>
    <primary_completion_date type="Anticipated">November 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>Test group will receive EMD mixed with freeze-dried bone allograft, Control group will receive freeze-dried bone allograft</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Participant, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Radiographic bone defect fill</measure>
      <time_frame>at baseline and 9 months</time_frame>
      <description>Cone Beam Computed Tomography (CBCT) will be taken prior to periodontal surgery and after 9 months.&#xD;
  The amount of reduction in the IBD measurements (defect resolution)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Clinical attachment level</measure>
      <time_frame>CAL will be measured at base line, 3, 6, 9 months postoperative</time_frame>
      <description>CAL will be measured from the CEJ to the bottom of the gingival sulcus/periodontal pocket using UNC periodontal probe at six sites per tooth</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Probing pocket depth</measure>
      <time_frame>PD will be measured at base line, 3, 6, 9 months postoperative</time_frame>
      <description>PD will be measured from the gingival margin to the bottom of the gingival sulcus/ periodontal pocket using UNC periodontal probe at six sites per tooth.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Plaque Index</measure>
      <time_frame>PI will be measured at base line, 3, 6, 9 months postoperative</time_frame>
      <description>Plaque index will be taken as an indicator for the patient oral hygiene.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Gingival Bleeding Index</measure>
      <time_frame>GBI will be measured at base line, 3, 6, 9 months postoperative</time_frame>
      <description>GBI will be measured according to Ainamo &amp; Bay (1975)</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Intrabony Periodontal Defect</condition>
    <arm_group>
      <arm_group_label>freeze-dried bone allograft combined with enamel matrix derivative</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The intrabony defects will be treated by surgical treatment and the defects filled by freeze-dried bone allograft mixed with enamel matrix derivative.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>freeze-dried bone allograft</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>The intrabony defects will be treated by surgical treatment and the defects filled by freeze-dried bone allograft.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Freeze-dried bone allograft combined with Enamel Matrix derivative</intervention_name>
      <description>The intrabony defects will be treated by minimally invasive surgical technique or modified minimally invasive surgical technique depending on defect extension, and the defects will be filled by freeze-dried bone allograft mixed with enamel matrix derivative.&#xD;
  Enamel matrix derivatives are natural proteins that are produced in the developing dental follicle.The major components of EMD are amelogenins, a family of hydrophobic porcine tooth-derived proteins. They account for more than 95% of the total EMD protein content. Other proteins found in the enamel matrix include enamelin, ameloblastin, amelotin, apin and various proteinases, which have found in trace amounts in EMD. EMD adsorbs on decontamined root surfaces and alveolar bony defects and forms an insoluble scaffold complex.</description>
      <arm_group_label>freeze-dried bone allograft combined with enamel matrix derivative</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Freeze-dried bone allograft</intervention_name>
      <description>The intrabony defects will be treated by minimally invasive surgical technique or modified minimally invasive surgical technique depending on defect extension, and the defects will be filled by freeze-dried bone allograft .&#xD;
  Allogeneic bone graft refers to bony tissue that is harvested from one individual and transplanted to a genetically different individual of the same species, principally osteoconductive, although it may have some osteoinductive capability, depending on how it is processed.</description>
      <arm_group_label>freeze-dried bone allograft</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age range between 30-50 years.&#xD;
  &#xD;
            -  Patients with stage III periodontitis, will be diagnosed on the basis of probing&#xD;
               pocket depth and clinical attachment loss.&#xD;
  &#xD;
            -  Presence of at least one or more radiographically detectable intrabony defect with&#xD;
               clinical periodontal pocket depth (PPD) ≥5 mm, clinical attachment loss ≥5 mm, and&#xD;
               radiographic depth of the intrabony defect ≥3 mm.&#xD;
  &#xD;
            -  No periodontal therapy within the last 6 months&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Smoker and alcoholic patient.&#xD;
  &#xD;
            -  Patient with any signs, symptoms or history of systemic disease that might affect the&#xD;
               periodontium and interfere with healing process.&#xD;
  &#xD;
            -  Pregnant patients.&#xD;
  &#xD;
            -  Patient who has traumatic occlusion.&#xD;
  &#xD;
            -  Uncooperative patient&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>30 Years</minimum_age>
      <maximum_age>50 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Jilan Youssef, Professor</last_name>
      <role>Study Chair</role>
      <affiliation>Mansoura University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Rouida Zakri, B.D.S, M.Sc</last_name>
      <phone>00201140224469</phone>
      <email>drzekri5@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Mansoura University</name>
        <address>
          <city>Mansoura</city>
          <country>Egypt</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Rouida Zakri, M.Sc</last_name>
        <phone>01140224469</phone>
        <email>drzekri5@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <reference>
      <citation>Kinane DF, Stathopoulou PG, Papapanou PN. Periodontal diseases. Nat Rev Dis Primers. 2017 Jun 22;3:17038. doi: 10.1038/nrdp.2017.38.</citation>
      <PMID>28805207</PMID>
    </reference>
    <reference>
      <citation>Garrett S. Periodontal regeneration around natural teeth. Ann Periodontol. 1996 Nov;1(1):621-66. doi: 10.1902/annals.1996.1.1.621.</citation>
      <PMID>9118274</PMID>
    </reference>
    <reference>
      <citation>Papapanou PN, Wennstrom JL. The angular bony defect as indicator of further alveolar bone loss. J Clin Periodontol. 1991 May;18(5):317-22. doi: 10.1111/j.1600-051x.1991.tb00435.x.</citation>
      <PMID>2066446</PMID>
    </reference>
    <reference>
      <citation>Reynolds MA, Kao RT, Camargo PM, Caton JG, Clem DS, Fiorellini JP, Geisinger ML, Mills MP, Nares S, Nevins ML. Periodontal regeneration - intrabony defects: a consensus report from the AAP Regeneration Workshop. J Periodontol. 2015 Feb;86(2 Suppl):S105-7. doi: 10.1902/jop.2015.140378. Epub 2014 Oct 15.</citation>
      <PMID>25315019</PMID>
    </reference>
    <reference>
      <citation>Cortellini P, Tonetti MS. Clinical concepts for regenerative therapy in intrabony defects. Periodontol 2000. 2015 Jun;68(1):282-307. doi: 10.1111/prd.12048.</citation>
      <PMID>25867990</PMID>
    </reference>
    <reference>
      <citation>Sculean A, Nikolidakis D, Nikou G, Ivanovic A, Chapple IL, Stavropoulos A. Biomaterials for promoting periodontal regeneration in human intrabony defects: a systematic review. Periodontol 2000. 2015 Jun;68(1):182-216. doi: 10.1111/prd.12086.</citation>
      <PMID>25867987</PMID>
    </reference>
    <reference>
      <citation>Nibali L, Koidou VP, Nieri M, Barbato L, Pagliaro U, Cairo F. Regenerative surgery versus access flap for the treatment of intra-bony periodontal defects: A systematic review and meta-analysis. J Clin Periodontol. 2020 Jul;47 Suppl 22:320-351. doi: 10.1111/jcpe.13237.</citation>
      <PMID>31860134</PMID>
    </reference>
    <reference>
      <citation>Mertens C, Decker C, Seeberger R, Hoffmann J, Sander A, Freier K. Early bone resorption after vertical bone augmentation--a comparison of calvarial and iliac grafts. Clin Oral Implants Res. 2013 Jul;24(7):820-5. doi: 10.1111/j.1600-0501.2012.02463.x. Epub 2012 Mar 27.</citation>
      <PMID>22458589</PMID>
    </reference>
    <reference>
      <citation>Palmer W, Crawford-Sykes A, Rose RE. Donor site morbidity following iliac crest bone graft. West Indian Med J. 2008 Nov;57(5):490-2.</citation>
      <PMID>19565981</PMID>
    </reference>
    <reference>
      <citation>Al-Abedalla K, Torres J, Cortes AR, Wu X, Nader SA, Daniel N, Tamimi F. Bone Augmented With Allograft Onlays for Implant Placement Could Be Comparable With Native Bone. J Oral Maxillofac Surg. 2015 Nov;73(11):2108-22. doi: 10.1016/j.joms.2015.06.151. Epub 2015 Jun 20.</citation>
      <PMID>26126920</PMID>
    </reference>
    <reference>
      <citation>Schlee M, Dehner JF, Baukloh K, Happe A, Seitz O, Sader R. Esthetic outcome of implant-based reconstructions in augmented bone: comparison of autologous and allogeneic bone block grafting with the pink esthetic score (PES). Head Face Med. 2014 May 28;10:21. doi: 10.1186/1746-160X-10-21.</citation>
      <PMID>24885136</PMID>
    </reference>
    <reference>
      <citation>Roberts TT, Rosenbaum AJ. Bone grafts, bone substitutes and orthobiologics: the bridge between basic science and clinical advancements in fracture healing. Organogenesis. 2012 Oct-Dec;8(4):114-24. doi: 10.4161/org.23306. Epub 2012 Oct 1.</citation>
      <PMID>23247591</PMID>
    </reference>
    <reference>
      <citation>Lorenz J, Schlee M, Al-Maawi S, Chia P, Sader RA, Ghanaati S. Variant Purification of an Allogeneic Bone Block. Acta Stomatol Croat. 2017 Jun;51(2):141-147. doi: 10.15644/asc51/2/7.</citation>
      <PMID>28827851</PMID>
    </reference>
    <reference>
      <citation>Trajkovski B, Jaunich M, Muller WD, Beuer F, Zafiropoulos GG, Houshmand A. Hydrophilicity, Viscoelastic, and Physicochemical Properties Variations in Dental Bone Grafting Substitutes. Materials (Basel). 2018 Jan 30;11(2):215. doi: 10.3390/ma11020215.</citation>
      <PMID>29385747</PMID>
    </reference>
    <reference>
      <citation>Corbella S, Alberti A, Calciolari E, Taschieri S, Francetti L. Enamel matrix derivative for the treatment of partially contained intrabony defects: 12-month results. Aust Dent J. 2019 Mar;64(1):27-34. doi: 10.1111/adj.12654. Epub 2018 Oct 15.</citation>
      <PMID>30257036</PMID>
    </reference>
    <reference>
      <citation>Lyngstadaas SP, Wohlfahrt JC, Brookes SJ, Paine ML, Snead ML, Reseland JE. Enamel matrix proteins; old molecules for new applications. Orthod Craniofac Res. 2009 Aug;12(3):243-53. doi: 10.1111/j.1601-6343.2009.01459.x.</citation>
      <PMID>19627527</PMID>
    </reference>
    <reference>
      <citation>Margolis HC, Beniash E, Fowler CE. Role of macromolecular assembly of enamel matrix proteins in enamel formation. J Dent Res. 2006 Sep;85(9):775-93. doi: 10.1177/154405910608500902.</citation>
      <PMID>16931858</PMID>
    </reference>
    <reference>
      <citation>Matarasso M, Iorio-Siciliano V, Blasi A, Ramaglia L, Salvi GE, Sculean A. Enamel matrix derivative and bone grafts for periodontal regeneration of intrabony defects. A systematic review and meta-analysis. Clin Oral Investig. 2015 Sep;19(7):1581-93. doi: 10.1007/s00784-015-1491-7. Epub 2015 May 27.</citation>
      <PMID>26008887</PMID>
    </reference>
    <reference>
      <citation>Lee MJ, Kim BO, Yu SJ. Clinical evaluation of a biphasic calcium phosphate grafting material in the treatment of human periodontal intrabony defects. J Periodontal Implant Sci. 2012 Aug;42(4):127-35. doi: 10.5051/jpis.2012.42.4.127. Epub 2012 Aug 31.</citation>
      <PMID>22977742</PMID>
    </reference>
    <reference>
      <citation>Cortellini P, Pini Prato G, Tonetti MS. Periodontal regeneration of human intrabony defects with titanium reinforced membranes. A controlled clinical trial. J Periodontol. 1995 Sep;66(9):797-803. doi: 10.1902/jop.1995.66.9.797.</citation>
      <PMID>7500246</PMID>
    </reference>
    <reference>
      <citation>Cornelini R, Scarano A, Piattelli M, Andreana S, Covani U, Quaranta A, Piattelli A. Effect of enamel matrix derivative (Emdogain) on bone defects in rabbit tibias. J Oral Implantol. 2004;30(2):69-73. doi: 10.1563/0.642.1.</citation>
      <PMID>15119455</PMID>
    </reference>
    <reference>
      <citation>Jung J, Park JS, Dard M, Al-Nawas B, Kwon YD. Effect of enamel matrix derivative liquid combined with synthetic bone substitute on bone regeneration in a rabbit calvarial model. Clin Oral Investig. 2021 Feb;25(2):547-554. doi: 10.1007/s00784-020-03473-4. Epub 2020 Aug 1.</citation>
      <PMID>32740811</PMID>
    </reference>
    <verification_date>March 2023</verification_date>
    <study_first_submitted>September 11, 2023</study_first_submitted>
    <study_first_submitted_qc>September 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 18, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Mansoura University</investigator_affiliation>
      <investigator_full_name>Rouida nouri</investigator_full_name>
      <investigator_title>M.Sc. - Master Degree of Oral Medicine &amp; Clinical Periodontology</investigator_title>
    </responsible_party>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06041854
  org study id: A02040122
  nct id: NCT06041854
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Periodontal intrabony defects represent a major challenge for the clinician in periodontal
        therapy. If left untreated, these defects represent a risk factor for disease progression and
        additional attachment and bone loss.
  
        All patients will receive full mouth scaling and root planing and be re-evaluated to assess
        patient cooperation and maintaining good oral hygiene. Subjects who showed persistent PPD ≥ 5
        mm with radiographic evidence of periodontal intrabony defect presence will be included and
        will be randomly allocated to one of two treatment groups.One group will be treated by
        surgical treatment and the defects filled by freeze-dried bone allograft mixed with enamel
        matrix derivative. second group will be treated by surgical treatment and the defects filled
        by freeze-dried bone allograft .Clinical periodontal parameters (PI, GBI, PPD, CAL) will be
        re-evaluated at 3, 6 and 9 months after surgery. CBCT will be taken after 9 months of surgery
        and the defect measurements will be recorded
  primary goal of periodontal therapy is not arrest the tissue destruction caused periodontal
        disease only, but also to reconstruct the tissue lost caused by infectious process.
        Periodontal intrabony defects represent a major challenge for the clinician in periodontal
        therapy. If left untreated, these defects represent a risk factor for disease progression and
        additional attachment and bone loss. Surgical intervention is considered the treatment of
        choice for deep intrabony defects, which have not resolved following completion of
        cause-related periodontal therapy.
  
        In general, periodontal studies showed that healing of periodontal defect after conventional
        periodontal therapy by collagenous tissue with epithelial cell migration within the gingival
        connective tissue and along the root surface. Therefore, a various of methods and techniques
        used to prevent epithelial ingrowth to the defect site and permit only a selective
        periodontal cells proliferation in attempt to regenerate periodontal tissues. Regenerative
        procedures including the use of certain types of bone replacement materials, barrier
        membranes, enamel matrix derivative (EMD), or various combinations thereof have been shown to
        facilitate periodontal regeneration characterized histologically by formation of root
        cementum, periodontal ligament, and alveolar bone and result superior in clinical, and
        radiographical patient reported outcomes compared to access flap surgery alone.
  
        Various bone graft and bone substitutes materials can be helpful in the tissue restoration.
        This bone graft include autogenous bone graft, allografts, xenografts, and alloplastic
        materials. Autologous bone is considered the gold standard because of its biological activity
        due to vital cells and growth factors. Yet, the autologous bone from intra-oral donor sites
        is of restricted quantities and availability, and the bone tissue obtained from the iliac
        crest is described to show faster resorption. Moreover, the harvesting of autologous bone
        often requires a second surgical site associated with an additional bone defect, potential
        donor site morbidity limiting their application.
  
        In recent years, the use of allogeneic human bone has been favored worldwide, and several
        histological and morphological studies have demonstrated that, there is no difference in the
        final stage of incorporation and new bone formation between allografts and autografts. Thus,
        the application of processed allogenic bone tissue is a reliable and predictable alternative.
  
        Allogeneic bone graft refers to bony tissue that is harvested from one individual and
        transplanted to a genetically different individual of the same species, principally
        osteoconductive, although it may have some osteoinductive capability, depending on how it is
        processed.
  
        Maxgraft® is allograft bone substitute processed by the Cells+Tissuebank Austria with a
        special cleaning process (Allotec® process). The purification process keeps the structural
        features and the interconnected macroporosity of human bone. It preserve natural bone
        structure and collagen content, therefore it serves as a scaffold for natural bone
        regeneration and has the potential of complete remodeling into patients' own bone. It is
        available as purely cancellous as well as cortico-cancellous granules and blocks.
  
        Recently, better outcomes have been reported with a combination of xenograft and enamel
        matrix derivative (EMD) as it combines the osteoconductive and space-making properties of
        bone grafts with the ability of bioactive materials to stimulate periodontal regeneration.
        The major components of EMD are amelogenins, a family of hydrophobic porcine tooth-derived
        proteins. They account for more than 95% of the total EMD protein content. Other proteins
        found in the enamel matrix include enamelin, ameloblastin, amelotin, apin and various
        proteinases, which have found in trace amounts in EMD. EMD adsorbs on decontamined root
        surfaces and alveolar bony defects and forms an insoluble scaffold complex.
  
        To the best of our knowledge, no previous studies have been performed for assessment of the
        efficacy of using emdogain with maxgraft.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Test group will receive EMD mixed with freeze-dried bone allograft, Control group will receive freeze-dried bone allograft
  primary purpose: Treatment
  masking: Double (Participant, Outcomes Assessor)
  measure: Radiographic bone defect fill
  time frame: at baseline and 9 months
  description: Cone Beam Computed Tomography (CBCT) will be taken prior to periodontal surgery and after 9 months.
  The amount of reduction in the IBD measurements (defect resolution)
  measure: Clinical attachment level
  time frame: CAL will be measured at base line, 3, 6, 9 months postoperative
  description: CAL will be measured from the CEJ to the bottom of the gingival sulcus/periodontal pocket using UNC periodontal probe at six sites per tooth
  measure: Probing pocket depth
  time frame: PD will be measured at base line, 3, 6, 9 months postoperative
  description: PD will be measured from the gingival margin to the bottom of the gingival sulcus/ periodontal pocket using UNC periodontal probe at six sites per tooth.
  measure: Plaque Index
  time frame: PI will be measured at base line, 3, 6, 9 months postoperative
  description: Plaque index will be taken as an indicator for the patient oral hygiene.
  measure: Gingival Bleeding Index
  time frame: GBI will be measured at base line, 3, 6, 9 months postoperative
  description: GBI will be measured according to Ainamo & Bay (1975)
  arm group label: freeze-dried bone allograft combined with enamel matrix derivative
  arm group type: Experimental
  description: The intrabony defects will be treated by surgical treatment and the defects filled by freeze-dried bone allograft mixed with enamel matrix derivative.
  arm group label: freeze-dried bone allograft
  arm group type: Active Comparator
  description: The intrabony defects will be treated by surgical treatment and the defects filled by freeze-dried bone allograft.
  intervention type: Procedure
  intervention name: Freeze-dried bone allograft combined with Enamel Matrix derivative
  description: The intrabony defects will be treated by minimally invasive surgical technique or modified minimally invasive surgical technique depending on defect extension, and the defects will be filled by freeze-dried bone allograft mixed with enamel matrix derivative.
  Enamel matrix derivatives are natural proteins that are produced in the developing dental follicle.The major components of EMD are amelogenins, a family of hydrophobic porcine tooth-derived proteins. They account for more than 95% of the total EMD protein content. Other proteins found in the enamel matrix include enamelin, ameloblastin, amelotin, apin and various proteinases, which have found in trace amounts in EMD. EMD adsorbs on decontamined root surfaces and alveolar bony defects and forms an insoluble scaffold complex.
  arm group label: freeze-dried bone allograft combined with enamel matrix derivative
  intervention type: Procedure
  intervention name: Freeze-dried bone allograft
  description: The intrabony defects will be treated by minimally invasive surgical technique or modified minimally invasive surgical technique depending on defect extension, and the defects will be filled by freeze-dried bone allograft .
  Allogeneic bone graft refers to bony tissue that is harvested from one individual and transplanted to a genetically different individual of the same species, principally osteoconductive, although it may have some osteoinductive capability, depending on how it is processed.
  arm group label: freeze-dried bone allograft
  criteria: 
  gender: All
  minimum age: 30 Years
  maximum age: 50 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Jilan Youssef, Professor
  role: Study Chair
  affiliation: Mansoura University
  last name: Rouida Zakri, B.D.S, M.Sc
  phone: 00201140224469
  email: drzekri5@gmail.com
  facility: 
  status: Recruiting
  contact: 
  country: Egypt
  citation: Kinane DF, Stathopoulou PG, Papapanou PN. Periodontal diseases. Nat Rev Dis Primers. 2017 Jun 22;3:17038. doi: 10.1038/nrdp.2017.38.
  PMID: 28805207
  citation: Garrett S. Periodontal regeneration around natural teeth. Ann Periodontol. 1996 Nov;1(1):621-66. doi: 10.1902/annals.1996.1.1.621.
  PMID: 9118274
  citation: Papapanou PN, Wennstrom JL. The angular bony defect as indicator of further alveolar bone loss. J Clin Periodontol. 1991 May;18(5):317-22. doi: 10.1111/j.1600-051x.1991.tb00435.x.
  PMID: 2066446
  citation: Reynolds MA, Kao RT, Camargo PM, Caton JG, Clem DS, Fiorellini JP, Geisinger ML, Mills MP, Nares S, Nevins ML. Periodontal regeneration - intrabony defects: a consensus report from the AAP Regeneration Workshop. J Periodontol. 2015 Feb;86(2 Suppl):S105-7. doi: 10.1902/jop.2015.140378. Epub 2014 Oct 15.
  PMID: 25315019
  citation: Cortellini P, Tonetti MS. Clinical concepts for regenerative therapy in intrabony defects. Periodontol 2000. 2015 Jun;68(1):282-307. doi: 10.1111/prd.12048.
  PMID: 25867990
  citation: Sculean A, Nikolidakis D, Nikou G, Ivanovic A, Chapple IL, Stavropoulos A. Biomaterials for promoting periodontal regeneration in human intrabony defects: a systematic review. Periodontol 2000. 2015 Jun;68(1):182-216. doi: 10.1111/prd.12086.
  PMID: 25867987
  citation: Nibali L, Koidou VP, Nieri M, Barbato L, Pagliaro U, Cairo F. Regenerative surgery versus access flap for the treatment of intra-bony periodontal defects: A systematic review and meta-analysis. J Clin Periodontol. 2020 Jul;47 Suppl 22:320-351. doi: 10.1111/jcpe.13237.
  PMID: 31860134
  citation: Mertens C, Decker C, Seeberger R, Hoffmann J, Sander A, Freier K. Early bone resorption after vertical bone augmentation--a comparison of calvarial and iliac grafts. Clin Oral Implants Res. 2013 Jul;24(7):820-5. doi: 10.1111/j.1600-0501.2012.02463.x. Epub 2012 Mar 27.
  PMID: 22458589
  citation: Palmer W, Crawford-Sykes A, Rose RE. Donor site morbidity following iliac crest bone graft. West Indian Med J. 2008 Nov;57(5):490-2.
  PMID: 19565981
  citation: Al-Abedalla K, Torres J, Cortes AR, Wu X, Nader SA, Daniel N, Tamimi F. Bone Augmented With Allograft Onlays for Implant Placement Could Be Comparable With Native Bone. J Oral Maxillofac Surg. 2015 Nov;73(11):2108-22. doi: 10.1016/j.joms.2015.06.151. Epub 2015 Jun 20.
  PMID: 26126920
  citation: Schlee M, Dehner JF, Baukloh K, Happe A, Seitz O, Sader R. Esthetic outcome of implant-based reconstructions in augmented bone: comparison of autologous and allogeneic bone block grafting with the pink esthetic score (PES). Head Face Med. 2014 May 28;10:21. doi: 10.1186/1746-160X-10-21.
  PMID: 24885136
  citation: Roberts TT, Rosenbaum AJ. Bone grafts, bone substitutes and orthobiologics: the bridge between basic science and clinical advancements in fracture healing. Organogenesis. 2012 Oct-Dec;8(4):114-24. doi: 10.4161/org.23306. Epub 2012 Oct 1.
  PMID: 23247591
  citation: Lorenz J, Schlee M, Al-Maawi S, Chia P, Sader RA, Ghanaati S. Variant Purification of an Allogeneic Bone Block. Acta Stomatol Croat. 2017 Jun;51(2):141-147. doi: 10.15644/asc51/2/7.
  PMID: 28827851
  citation: Trajkovski B, Jaunich M, Muller WD, Beuer F, Zafiropoulos GG, Houshmand A. Hydrophilicity, Viscoelastic, and Physicochemical Properties Variations in Dental Bone Grafting Substitutes. Materials (Basel). 2018 Jan 30;11(2):215. doi: 10.3390/ma11020215.
  PMID: 29385747
  citation: Corbella S, Alberti A, Calciolari E, Taschieri S, Francetti L. Enamel matrix derivative for the treatment of partially contained intrabony defects: 12-month results. Aust Dent J. 2019 Mar;64(1):27-34. doi: 10.1111/adj.12654. Epub 2018 Oct 15.
  PMID: 30257036
  citation: Lyngstadaas SP, Wohlfahrt JC, Brookes SJ, Paine ML, Snead ML, Reseland JE. Enamel matrix proteins; old molecules for new applications. Orthod Craniofac Res. 2009 Aug;12(3):243-53. doi: 10.1111/j.1601-6343.2009.01459.x.
  PMID: 19627527
  citation: Margolis HC, Beniash E, Fowler CE. Role of macromolecular assembly of enamel matrix proteins in enamel formation. J Dent Res. 2006 Sep;85(9):775-93. doi: 10.1177/154405910608500902.
  PMID: 16931858
  citation: Matarasso M, Iorio-Siciliano V, Blasi A, Ramaglia L, Salvi GE, Sculean A. Enamel matrix derivative and bone grafts for periodontal regeneration of intrabony defects. A systematic review and meta-analysis. Clin Oral Investig. 2015 Sep;19(7):1581-93. doi: 10.1007/s00784-015-1491-7. Epub 2015 May 27.
  PMID: 26008887
  citation: Lee MJ, Kim BO, Yu SJ. Clinical evaluation of a biphasic calcium phosphate grafting material in the treatment of human periodontal intrabony defects. J Periodontal Implant Sci. 2012 Aug;42(4):127-35. doi: 10.5051/jpis.2012.42.4.127. Epub 2012 Aug 31.
  PMID: 22977742
  citation: Cortellini P, Pini Prato G, Tonetti MS. Periodontal regeneration of human intrabony defects with titanium reinforced membranes. A controlled clinical trial. J Periodontol. 1995 Sep;66(9):797-803. doi: 10.1902/jop.1995.66.9.797.
  PMID: 7500246
  citation: Cornelini R, Scarano A, Piattelli M, Andreana S, Covani U, Quaranta A, Piattelli A. Effect of enamel matrix derivative (Emdogain) on bone defects in rabbit tibias. J Oral Implantol. 2004;30(2):69-73. doi: 10.1563/0.642.1.
  PMID: 15119455
  citation: Jung J, Park JS, Dard M, Al-Nawas B, Kwon YD. Effect of enamel matrix derivative liquid combined with synthetic bone substitute on bone regeneration in a rabbit calvarial model. Clin Oral Investig. 2021 Feb;25(2):547-554. doi: 10.1007/s00784-020-03473-4. Epub 2020 Aug 1.
  PMID: 32740811
  responsible party type: Principal Investigator
  investigator affiliation: Mansoura University
  investigator full name: Rouida nouri
  investigator title: M.Sc. - Master Degree of Oral Medicine & Clinical Periodontology
  sharing ipd: No