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/NCT05989061</url>
    </required_header>
    <id_info>
      <org_study_id>FDASU-RecIM122219</org_study_id>
      <nct_id>NCT05989061</nct_id>
    </id_info>
    <brief_title>PEEK Versus Titanium Customized Healing Abutments</brief_title>
    <official_title>PEEK Versus Titanium Customized Healing Abutments: Evaluation of Peri-implant Soft Tissues and Sulcus Fluid Bacterial Load</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ain Shams University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Ain Shams University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The study suggests that if the investigators used customized healing abutments synthesized&#xD;
        from PEEK may have a favorable effect on peri-implant soft tissues regarding decreased plaque&#xD;
        accumulation and healing stimulation compared to the customized conventional titanium healing&#xD;
        abutments.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Successful aesthetic implant therapy has several sequential goals such as prosthetically&#xD;
        driven 3D implant placement. Implant placement must be done in the ideal position to support&#xD;
        the restoration and the surrounding soft and hard tissues. The placement of a definitive&#xD;
        restoration should also be in harmony with the adjacent natural teeth and surrounding soft&#xD;
        tissue.&#xD;
  &#xD;
        Guided implant surgery can provide precise, predictable, and safe implant placement.&#xD;
        Computer-generated surgical guides vary in design according to the dental condition&#xD;
        (edentulous or partially edentulous), type of support (tooth, mucosa, or bone), and the&#xD;
        degree of limitation (non-limiting, partially-limiting, or completely limiting).&#xD;
  &#xD;
        The use of healing abutments has the function which enables adequate healing of peri-implant&#xD;
        soft tissue and promoting a good profile of peri-implant mucosa that allows an adequate&#xD;
        emergence profile of the prostheses supported by the implant. They are available in different&#xD;
        lengths and project through the soft tissue into the oral cavity.&#xD;
  &#xD;
        Janakievski stated that prefabricated healing abutments are unable to support the&#xD;
        supracrestal soft tissues because of their circular profile. Therefore, a custom healing&#xD;
        abutment is preferred because it provides a replica of the definitive restoration of the&#xD;
        patient's gingival architecture.&#xD;
  &#xD;
        An evaluation of the use of customized healing abutments has been performed aiming to assess&#xD;
        possible advantages associated with this treatment modality. This procedure allows to&#xD;
        maintain the peri-implant tissue and improve aesthetics until crown delivery. CAD/CAM enables&#xD;
        the fabrication of high-quality implant abutments from solid blocks of different materials.&#xD;
  &#xD;
        The contours of the healing abutment are based on the contours of a provisionally designed&#xD;
        definitive prosthesis. The healing abutment promotes tissue healing and obtains contours that&#xD;
        are well-matched with the contours of the definitive prosthesis.&#xD;
  &#xD;
        Currently healing abutments made of polymers such as polyetheretherketone (PEEK) which have&#xD;
        been used in orthopedic surgery, are used in dentistry, because of aesthetic &amp; biological&#xD;
        reasons maintaining the health of peri-implant soft tissues during healing.&#xD;
  &#xD;
        Polyetheretherketone (PEEK) healing abutments can be chosen instead of titanium healing&#xD;
        abutments because of their superior properties such as biocompatibility, inert chemical&#xD;
        properties, white color, and decreased liability for biofilm accumulation.&#xD;
  &#xD;
        Research Question &quot;May PEEK healing abutment have a favorable effect on peri-implant soft&#xD;
        tissue that may be related to the superior biological properties of PEEK regarding both&#xD;
        decreased biofilm accumulation&amp; healing stimulation?&quot;&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">October 2024</completion_date>
    <primary_completion_date type="Anticipated">September 1, 2024</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>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Clinical evaluation of peri-implant soft tissue changes</measure>
      <time_frame>1 month after implantation and 4 months after implantation (just before prosthetic procedures)</time_frame>
      <description>Clinical evaluation of peri-implant soft tissue changes the Probing Depth (PD).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Clinical evaluation of peri-implant soft tissue changes</measure>
      <time_frame>1 month after implantation and 4 months after implantation (just before prosthetic procedures)</time_frame>
      <description>Clinical evaluation of peri-implant soft tissue changes the Plaque Index (PI) score.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Clinical evaluation of peri-implant soft tissue changes</measure>
      <time_frame>1 month after implantation and 4 months after implantation (just before prosthetic procedures)</time_frame>
      <description>Clinical evaluation of peri-implant soft tissue changes the Gingival Index (GI)score.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Clinical evaluation of peri-implant soft tissue changes</measure>
      <time_frame>1 month after implantation and 4 months after implantation (just before prosthetic procedures)</time_frame>
      <description>Clinical evaluation of peri-implant soft tissue changes the Gingival Bleeding Time Index (GBTI).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Clinical evaluation of peri-implant soft tissue changes</measure>
      <time_frame>1 month after implantation and 4 months after implantation (just before prosthetic procedures)</time_frame>
      <description>Clinical evaluation of peri-implant soft tissue changes the Width of keratinized tissue (WKT).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Biochemical evaluation</measure>
      <time_frame>1 month after implantation and 4 months after implantation (just before prosthetic procedures)</time_frame>
      <description>Biochemical evaluation of peri-implant sulcus fluid (PISF) total bacterial load.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">26</enrollment>
    <condition>Dental Implants</condition>
    <arm_group>
      <arm_group_label>PEEK customized healing abutment.</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Group I (Customized PEEK Healing Abutment):&#xD;
  13 patients will receive guided delayed implant and a customized PEEK healing abutment placed simultaneously with implant surgery</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Titanium customized healing abutment.</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Group II (Customized Titanium Healing Abutment):&#xD;
  13 patients will receive guided delayed implant and a customized titanium healing abutment placed simultaneously with implant surgery.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>PEEK customized healing abutment</intervention_name>
      <description>Guided delayed implant and a customized PEEK healing abutment placed simultaneously with implant surgery</description>
      <arm_group_label>PEEK customized healing abutment.</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Titanium customized healing abutment</intervention_name>
      <description>Guided delayed implant and a customized Titanium healing abutment placed simultaneously with implant surgery</description>
      <arm_group_label>Titanium customized healing abutment.</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Patients should be systematically free from any disease as according to Cornell&#xD;
               Medical Index-Health Questionnaire .&#xD;
  &#xD;
            2. Both genders.&#xD;
  &#xD;
            3. Age from 20-50 years.&#xD;
  &#xD;
            4. Missing tooth in esthetic zone (Anterior/Premolar) to be restored with standard&#xD;
               implant, with no need for additional bone and soft tissue augmentation procedures.&#xD;
  &#xD;
            5. Implants primary stability ISQ ≥ 70 unites using the Osstell Mentor&#xD;
  &#xD;
            6. BuccoLingual bone width ≥ 6 mm.&#xD;
  &#xD;
            7. Mesio distal space ≥ 7 mm&#xD;
  &#xD;
            8. Sound Mesial and distal neighboring teeth.&#xD;
  &#xD;
            9. At least 6 natural teeth remaining in the same arch .&#xD;
  &#xD;
           10. Mouth opening ≥ 30mm.&#xD;
  &#xD;
           11. Enough keratinized mucosa.&#xD;
  &#xD;
           12. Thick phenotype.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Poor oral hygiene condition.&#xD;
  &#xD;
            2. Pregnant and lactating females.&#xD;
  &#xD;
            3. Smokers.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>50 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Ahmed E. Amr, Assoc Prof</last_name>
      <role>Study Director</role>
      <affiliation>Ain Shams University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Samar F. El Desouki, Master student</last_name>
      <phone>+201010876119</phone>
      <email>SamarFakhrEldin@dent.asu.edu.eg</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Hadeel G. Al Malahy, Lecturer</last_name>
      <phone>+201017767662</phone>
      <email>dr.hadeel@dent.asu.edu.eg</email>
    </overall_contact_backup>
    <reference>
      <citation>Baltayan S, Pi-Anfruns J, Aghaloo T, Moy PK. The Predictive Value of Resonance Frequency Analysis Measurements in the Surgical Placement and Loading of Endosseous Implants. J Oral Maxillofac Surg. 2016 Jun;74(6):1145-52. doi: 10.1016/j.joms.2016.01.048. Epub 2016 Feb 1.</citation>
      <PMID>26917203</PMID>
    </reference>
    <reference>
      <citation>Beretta M, Poli PP, Pieriboni S, Tansella S, Manfredini M, Cicciu M, Maiorana C. Peri-Implant Soft Tissue Conditioning by Means of Customized Healing Abutment: A Randomized Controlled Clinical Trial. Materials (Basel). 2019 Sep 19;12(18):3041. doi: 10.3390/ma12183041.</citation>
      <PMID>31546800</PMID>
    </reference>
    <reference>
      <citation>Cakan U, Delilbasi C, Er S, Kivanc M. Is it safe to reuse dental implant healing abutments sterilized and serviced by dealers of dental implant manufacturers? An in vitro sterility analysis. Implant Dent. 2015 Apr;24(2):174-9. doi: 10.1097/ID.0000000000000198.</citation>
      <PMID>25706262</PMID>
    </reference>
    <reference>
      <citation>Chen ST, Buser D. Clinical and esthetic outcomes of implants placed in postextraction sites. Int J Oral Maxillofac Implants. 2009;24 Suppl:186-217.</citation>
      <PMID>19885446</PMID>
    </reference>
    <reference>
      <citation>Chen ST, Buser D. Esthetic outcomes following immediate and early implant placement in the anterior maxilla--a systematic review. Int J Oral Maxillofac Implants. 2014;29 Suppl:186-215. doi: 10.11607/jomi.2014suppl.g3.3.</citation>
      <PMID>24660198</PMID>
    </reference>
    <reference>
      <citation>Chew M, Tompkins G, Tawse-Smith A, Waddell JN, Ma S. Reusing Titanium Healing Abutments: Comparison of Two Decontamination Methods. Int J Prosthodont. 2018 November/December;31(6):613-618. doi: 10.11607/ijp.5881. Epub 2018 Jul 30.</citation>
      <PMID>30339159</PMID>
    </reference>
    <reference>
      <citation>Cochran DL, Nummikoski PV, Schoolfield JD, Jones AA, Oates TW. A prospective multicenter 5-year radiographic evaluation of crestal bone levels over time in 596 dental implants placed in 192 patients. J Periodontol. 2009 May;80(5):725-33. doi: 10.1902/jop.2009.080401.</citation>
      <PMID>19405825</PMID>
    </reference>
    <reference>
      <citation>de Almeida EO, Pellizzer EP, Goiatto MC, Margonar R, Rocha EP, Freitas AC Jr, Anchieta RB. Computer-guided surgery in implantology: review of basic concepts. J Craniofac Surg. 2010 Nov;21(6):1917-21. doi: 10.1097/SCS.0b013e3181f4b1a0.</citation>
      <PMID>21119455</PMID>
    </reference>
    <reference>
      <citation>Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.</citation>
      <PMID>17695343</PMID>
    </reference>
    <reference>
      <citation>Finelle G, Lee SJ. Guided Immediate Implant Placement with Wound Closure by Computer-Aided Design/Computer-Assisted Manufacture Sealing Socket Abutment: Case Report. Int J Oral Maxillofac Implants. 2017 Mar/Apr;32(2):e63-e67. doi: 10.11607/jomi.4770.</citation>
      <PMID>28291855</PMID>
    </reference>
    <reference>
      <citation>Jemt T. Measurements of tooth movements in relation to single-implant restorations during 16 years: a case report. Clin Implant Dent Relat Res. 2005;7(4):200-8. doi: 10.1111/j.1708-8208.2005.tb00065.x.</citation>
      <PMID>16336911</PMID>
    </reference>
    <reference>
      <citation>Joda T, Ferrari M, Braegger U. A digital approach for one-step formation of the supra-implant emergence profile with an individualized CAD/CAM healing abutment. J Prosthodont Res. 2016 Jul;60(3):220-3. doi: 10.1016/j.jpor.2016.01.005. Epub 2016 Feb 9.</citation>
      <PMID>26868927</PMID>
    </reference>
    <reference>
      <citation>Lang LA, Sierraalta M, Hoffensperger M, Wang RF. Evaluation of the precision of fit between the Procera custom abutment and various implant systems. Int J Oral Maxillofac Implants. 2003 Sep-Oct;18(5):652-8.</citation>
      <PMID>14579952</PMID>
    </reference>
    <reference>
      <citation>Margonar R, Queiroz TP, Luvizuto ER, Betoni-Junior W, Zocal EA. Mandibular rehabilitation using immediate implant loading after computer-guided surgery. J Craniofac Surg. 2012 Mar;23(2):e129-32. doi: 10.1097/SCS.0b013e31824cdb74.</citation>
      <PMID>22446446</PMID>
    </reference>
    <reference>
      <citation>Mehra M, Somohano T, Choi M. Mandibular fibular graft reconstruction with CAD/CAM technology: A clinical report and literature review. J Prosthet Dent. 2016 Jan;115(1):123-8. doi: 10.1016/j.prosdent.2015.05.012. Epub 2015 Sep 11.</citation>
      <PMID>26372630</PMID>
    </reference>
    <reference>
      <citation>Molina A, Sanz-Sanchez I, Martin C, Blanco J, Sanz M. The effect of one-time abutment placement on interproximal bone levels and peri-implant soft tissues: a prospective randomized clinical trial. Clin Oral Implants Res. 2017 Apr;28(4):443-452. doi: 10.1111/clr.12818. Epub 2016 Mar 25.</citation>
      <PMID>27016157</PMID>
    </reference>
    <reference>
      <citation>Akoglan M, Tatli U, Kurtoglu C, Salimov F, Kurkcu M. Effects of different loading protocols on the secondary stability and peri-implant bone density of the single implants in the posterior maxilla. Clin Implant Dent Relat Res. 2017 Aug;19(4):624-631. doi: 10.1111/cid.12492. Epub 2017 May 10.</citation>
      <PMID>28493347</PMID>
    </reference>
    <reference>
      <citation>Pow EH, McMillan AS. A modified implant healing abutment to optimize soft tissue contours: a case report. Implant Dent. 2004 Dec;13(4):297-300. doi: 10.1097/01.id.0000144510.66524.87.</citation>
      <PMID>15591990</PMID>
    </reference>
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      <citation>Priest G. Virtual-designed and computer-milled implant abutments. J Oral Maxillofac Surg. 2005 Sep;63(9 Suppl 2):22-32. doi: 10.1016/j.joms.2005.05.158.</citation>
      <PMID>16125013</PMID>
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      <citation>Proussaefs P. Immediate provisionalization with a CAD/CAM interim abutment and crown: a guided soft tissue healing technique. J Prosthet Dent. 2015 Feb;113(2):91-5. doi: 10.1016/j.prosdent.2014.09.003. Epub 2014 Oct 28.</citation>
      <PMID>25438739</PMID>
    </reference>
    <reference>
      <citation>Pyo SW, Lim YJ, Koo KT, Lee J. Methods Used to Assess the 3D Accuracy of Dental Implant Positions in Computer-Guided Implant Placement: A Review. J Clin Med. 2019 Jan 7;8(1):54. doi: 10.3390/jcm8010054.</citation>
      <PMID>30621034</PMID>
    </reference>
    <reference>
      <citation>Rea M, Ricci S, Ghensi P, Lang NP, Botticelli D, Soldini C. Marginal healing using Polyetheretherketone as healing abutments: an experimental study in dogs. Clin Oral Implants Res. 2017 Jul;28(7):e46-e50. doi: 10.1111/clr.12854. Epub 2016 Apr 15.</citation>
      <PMID>27080305</PMID>
    </reference>
    <reference>
      <citation>Susin C, Finger Stadler A, Fiorini T, de Sousa Rabelo M, Ramos UD, Schupbach P. Safety and efficacy of a novel anodized abutment on soft tissue healing in Yucatan mini-pigs. Clin Implant Dent Relat Res. 2019 Mar;21 Suppl 1:34-43. doi: 10.1111/cid.12755. Epub 2019 Mar 12.</citation>
      <PMID>30859699</PMID>
    </reference>
    <reference>
      <citation>Wadhwani C, Schonnenbaum TR, Audia F, Chung KH. In-Vitro Study of the Contamination Remaining on Used Healing Abutments after Cleaning and Sterilizing in Dental Practice. Clin Implant Dent Relat Res. 2016 Dec;18(6):1069-1074. doi: 10.1111/cid.12385. Epub 2015 Dec 7.</citation>
      <PMID>26640198</PMID>
    </reference>
    <reference>
      <citation>Yunus N, Masood M, Saub R, Al-Hashedi AA, Taiyeb Ali TB, Thomason JM. Impact of mandibular implant prostheses on the oral health-related quality of life in partially and completely edentulous patients. Clin Oral Implants Res. 2016 Jul;27(7):904-9. doi: 10.1111/clr.12657. Epub 2015 Jul 14.</citation>
      <PMID>26173463</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 10, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 10, 2023</last_update_submitted>
    <last_update_submitted_qc>August 10, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Ain Shams University</investigator_affiliation>
      <investigator_full_name>Samar El Desouki</investigator_full_name>
      <investigator_title>Master student</investigator_title>
    </responsible_party>
    <keyword>Customized Healing Abutment</keyword>
    <keyword>PEEK</keyword>
    <keyword>Peri-implant soft tissue</keyword>
    <keyword>Dental implants</keyword>
    <keyword>Titanium</keyword>
    <keyword>Esthetic Zone</keyword>
    <provided_document_section>
      <provided_document>
        <document_type>Study Protocol and Statistical Analysis Plan</document_type>
        <document_has_protocol>Yes</document_has_protocol>
        <document_has_icf>No</document_has_icf>
        <document_has_sap>Yes</document_has_sap>
        <document_date>December 21, 2022</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/61/NCT05989061/Prot_SAP_000.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- 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/NCT05989061
  org study id: FDASU-RecIM122219
  nct id: NCT05989061
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  The study suggests that if the investigators used customized healing abutments synthesized
        from PEEK may have a favorable effect on peri-implant soft tissues regarding decreased plaque
        accumulation and healing stimulation compared to the customized conventional titanium healing
        abutments.
  Successful aesthetic implant therapy has several sequential goals such as prosthetically
        driven 3D implant placement. Implant placement must be done in the ideal position to support
        the restoration and the surrounding soft and hard tissues. The placement of a definitive
        restoration should also be in harmony with the adjacent natural teeth and surrounding soft
        tissue.
  
        Guided implant surgery can provide precise, predictable, and safe implant placement.
        Computer-generated surgical guides vary in design according to the dental condition
        (edentulous or partially edentulous), type of support (tooth, mucosa, or bone), and the
        degree of limitation (non-limiting, partially-limiting, or completely limiting).
  
        The use of healing abutments has the function which enables adequate healing of peri-implant
        soft tissue and promoting a good profile of peri-implant mucosa that allows an adequate
        emergence profile of the prostheses supported by the implant. They are available in different
        lengths and project through the soft tissue into the oral cavity.
  
        Janakievski stated that prefabricated healing abutments are unable to support the
        supracrestal soft tissues because of their circular profile. Therefore, a custom healing
        abutment is preferred because it provides a replica of the definitive restoration of the
        patient's gingival architecture.
  
        An evaluation of the use of customized healing abutments has been performed aiming to assess
        possible advantages associated with this treatment modality. This procedure allows to
        maintain the peri-implant tissue and improve aesthetics until crown delivery. CAD/CAM enables
        the fabrication of high-quality implant abutments from solid blocks of different materials.
  
        The contours of the healing abutment are based on the contours of a provisionally designed
        definitive prosthesis. The healing abutment promotes tissue healing and obtains contours that
        are well-matched with the contours of the definitive prosthesis.
  
        Currently healing abutments made of polymers such as polyetheretherketone (PEEK) which have
        been used in orthopedic surgery, are used in dentistry, because of aesthetic & biological
        reasons maintaining the health of peri-implant soft tissues during healing.
  
        Polyetheretherketone (PEEK) healing abutments can be chosen instead of titanium healing
        abutments because of their superior properties such as biocompatibility, inert chemical
        properties, white color, and decreased liability for biofilm accumulation.
  
        Research Question "May PEEK healing abutment have a favorable effect on peri-implant soft
        tissue that may be related to the superior biological properties of PEEK regarding both
        decreased biofilm accumulation& healing stimulation?"
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  measure: Clinical evaluation of peri-implant soft tissue changes
  time frame: 1 month after implantation and 4 months after implantation (just before prosthetic procedures)
  description: Clinical evaluation of peri-implant soft tissue changes the Probing Depth (PD).
  measure: Clinical evaluation of peri-implant soft tissue changes
  time frame: 1 month after implantation and 4 months after implantation (just before prosthetic procedures)
  description: Clinical evaluation of peri-implant soft tissue changes the Plaque Index (PI) score.
  measure: Clinical evaluation of peri-implant soft tissue changes
  time frame: 1 month after implantation and 4 months after implantation (just before prosthetic procedures)
  description: Clinical evaluation of peri-implant soft tissue changes the Gingival Index (GI)score.
  measure: Clinical evaluation of peri-implant soft tissue changes
  time frame: 1 month after implantation and 4 months after implantation (just before prosthetic procedures)
  description: Clinical evaluation of peri-implant soft tissue changes the Gingival Bleeding Time Index (GBTI).
  measure: Clinical evaluation of peri-implant soft tissue changes
  time frame: 1 month after implantation and 4 months after implantation (just before prosthetic procedures)
  description: Clinical evaluation of peri-implant soft tissue changes the Width of keratinized tissue (WKT).
  measure: Biochemical evaluation
  time frame: 1 month after implantation and 4 months after implantation (just before prosthetic procedures)
  description: Biochemical evaluation of peri-implant sulcus fluid (PISF) total bacterial load.
  arm group label: PEEK customized healing abutment.
  arm group type: Experimental
  description: Group I (Customized PEEK Healing Abutment):
  13 patients will receive guided delayed implant and a customized PEEK healing abutment placed simultaneously with implant surgery
  arm group label: Titanium customized healing abutment.
  arm group type: Active Comparator
  description: Group II (Customized Titanium Healing Abutment):
  13 patients will receive guided delayed implant and a customized titanium healing abutment placed simultaneously with implant surgery.
  intervention type: Device
  intervention name: PEEK customized healing abutment
  description: Guided delayed implant and a customized PEEK healing abutment placed simultaneously with implant surgery
  arm group label: PEEK customized healing abutment.
  intervention type: Device
  intervention name: Titanium customized healing abutment
  description: Guided delayed implant and a customized Titanium healing abutment placed simultaneously with implant surgery
  arm group label: Titanium customized healing abutment.
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: 50 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Ahmed E. Amr, Assoc Prof
  role: Study Director
  affiliation: Ain Shams University
  last name: Samar F. El Desouki, Master student
  phone: +201010876119
  email: SamarFakhrEldin@dent.asu.edu.eg
  last name: Hadeel G. Al Malahy, Lecturer
  phone: +201017767662
  email: dr.hadeel@dent.asu.edu.eg
  citation: Baltayan S, Pi-Anfruns J, Aghaloo T, Moy PK. The Predictive Value of Resonance Frequency Analysis Measurements in the Surgical Placement and Loading of Endosseous Implants. J Oral Maxillofac Surg. 2016 Jun;74(6):1145-52. doi: 10.1016/j.joms.2016.01.048. Epub 2016 Feb 1.
  PMID: 26917203
  citation: Beretta M, Poli PP, Pieriboni S, Tansella S, Manfredini M, Cicciu M, Maiorana C. Peri-Implant Soft Tissue Conditioning by Means of Customized Healing Abutment: A Randomized Controlled Clinical Trial. Materials (Basel). 2019 Sep 19;12(18):3041. doi: 10.3390/ma12183041.
  PMID: 31546800
  citation: Cakan U, Delilbasi C, Er S, Kivanc M. Is it safe to reuse dental implant healing abutments sterilized and serviced by dealers of dental implant manufacturers? An in vitro sterility analysis. Implant Dent. 2015 Apr;24(2):174-9. doi: 10.1097/ID.0000000000000198.
  PMID: 25706262
  citation: Chen ST, Buser D. Clinical and esthetic outcomes of implants placed in postextraction sites. Int J Oral Maxillofac Implants. 2009;24 Suppl:186-217.
  PMID: 19885446
  citation: Chen ST, Buser D. Esthetic outcomes following immediate and early implant placement in the anterior maxilla--a systematic review. Int J Oral Maxillofac Implants. 2014;29 Suppl:186-215. doi: 10.11607/jomi.2014suppl.g3.3.
  PMID: 24660198
  citation: Chew M, Tompkins G, Tawse-Smith A, Waddell JN, Ma S. Reusing Titanium Healing Abutments: Comparison of Two Decontamination Methods. Int J Prosthodont. 2018 November/December;31(6):613-618. doi: 10.11607/ijp.5881. Epub 2018 Jul 30.
  PMID: 30339159
  citation: Cochran DL, Nummikoski PV, Schoolfield JD, Jones AA, Oates TW. A prospective multicenter 5-year radiographic evaluation of crestal bone levels over time in 596 dental implants placed in 192 patients. J Periodontol. 2009 May;80(5):725-33. doi: 10.1902/jop.2009.080401.
  PMID: 19405825
  citation: de Almeida EO, Pellizzer EP, Goiatto MC, Margonar R, Rocha EP, Freitas AC Jr, Anchieta RB. Computer-guided surgery in implantology: review of basic concepts. J Craniofac Surg. 2010 Nov;21(6):1917-21. doi: 10.1097/SCS.0b013e3181f4b1a0.
  PMID: 21119455
  citation: Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.
  PMID: 17695343
  citation: Finelle G, Lee SJ. Guided Immediate Implant Placement with Wound Closure by Computer-Aided Design/Computer-Assisted Manufacture Sealing Socket Abutment: Case Report. Int J Oral Maxillofac Implants. 2017 Mar/Apr;32(2):e63-e67. doi: 10.11607/jomi.4770.
  PMID: 28291855
  citation: Jemt T. Measurements of tooth movements in relation to single-implant restorations during 16 years: a case report. Clin Implant Dent Relat Res. 2005;7(4):200-8. doi: 10.1111/j.1708-8208.2005.tb00065.x.
  PMID: 16336911
  citation: Joda T, Ferrari M, Braegger U. A digital approach for one-step formation of the supra-implant emergence profile with an individualized CAD/CAM healing abutment. J Prosthodont Res. 2016 Jul;60(3):220-3. doi: 10.1016/j.jpor.2016.01.005. Epub 2016 Feb 9.
  PMID: 26868927
  citation: Lang LA, Sierraalta M, Hoffensperger M, Wang RF. Evaluation of the precision of fit between the Procera custom abutment and various implant systems. Int J Oral Maxillofac Implants. 2003 Sep-Oct;18(5):652-8.
  PMID: 14579952
  citation: Margonar R, Queiroz TP, Luvizuto ER, Betoni-Junior W, Zocal EA. Mandibular rehabilitation using immediate implant loading after computer-guided surgery. J Craniofac Surg. 2012 Mar;23(2):e129-32. doi: 10.1097/SCS.0b013e31824cdb74.
  PMID: 22446446
  citation: Mehra M, Somohano T, Choi M. Mandibular fibular graft reconstruction with CAD/CAM technology: A clinical report and literature review. J Prosthet Dent. 2016 Jan;115(1):123-8. doi: 10.1016/j.prosdent.2015.05.012. Epub 2015 Sep 11.
  PMID: 26372630
  citation: Molina A, Sanz-Sanchez I, Martin C, Blanco J, Sanz M. The effect of one-time abutment placement on interproximal bone levels and peri-implant soft tissues: a prospective randomized clinical trial. Clin Oral Implants Res. 2017 Apr;28(4):443-452. doi: 10.1111/clr.12818. Epub 2016 Mar 25.
  PMID: 27016157
  citation: Akoglan M, Tatli U, Kurtoglu C, Salimov F, Kurkcu M. Effects of different loading protocols on the secondary stability and peri-implant bone density of the single implants in the posterior maxilla. Clin Implant Dent Relat Res. 2017 Aug;19(4):624-631. doi: 10.1111/cid.12492. Epub 2017 May 10.
  PMID: 28493347
  citation: Pow EH, McMillan AS. A modified implant healing abutment to optimize soft tissue contours: a case report. Implant Dent. 2004 Dec;13(4):297-300. doi: 10.1097/01.id.0000144510.66524.87.
  PMID: 15591990
  citation: Priest G. Virtual-designed and computer-milled implant abutments. J Oral Maxillofac Surg. 2005 Sep;63(9 Suppl 2):22-32. doi: 10.1016/j.joms.2005.05.158.
  PMID: 16125013
  citation: Proussaefs P. Immediate provisionalization with a CAD/CAM interim abutment and crown: a guided soft tissue healing technique. J Prosthet Dent. 2015 Feb;113(2):91-5. doi: 10.1016/j.prosdent.2014.09.003. Epub 2014 Oct 28.
  PMID: 25438739
  citation: Pyo SW, Lim YJ, Koo KT, Lee J. Methods Used to Assess the 3D Accuracy of Dental Implant Positions in Computer-Guided Implant Placement: A Review. J Clin Med. 2019 Jan 7;8(1):54. doi: 10.3390/jcm8010054.
  PMID: 30621034
  citation: Rea M, Ricci S, Ghensi P, Lang NP, Botticelli D, Soldini C. Marginal healing using Polyetheretherketone as healing abutments: an experimental study in dogs. Clin Oral Implants Res. 2017 Jul;28(7):e46-e50. doi: 10.1111/clr.12854. Epub 2016 Apr 15.
  PMID: 27080305
  citation: Susin C, Finger Stadler A, Fiorini T, de Sousa Rabelo M, Ramos UD, Schupbach P. Safety and efficacy of a novel anodized abutment on soft tissue healing in Yucatan mini-pigs. Clin Implant Dent Relat Res. 2019 Mar;21 Suppl 1:34-43. doi: 10.1111/cid.12755. Epub 2019 Mar 12.
  PMID: 30859699
  citation: Wadhwani C, Schonnenbaum TR, Audia F, Chung KH. In-Vitro Study of the Contamination Remaining on Used Healing Abutments after Cleaning and Sterilizing in Dental Practice. Clin Implant Dent Relat Res. 2016 Dec;18(6):1069-1074. doi: 10.1111/cid.12385. Epub 2015 Dec 7.
  PMID: 26640198
  citation: Yunus N, Masood M, Saub R, Al-Hashedi AA, Taiyeb Ali TB, Thomason JM. Impact of mandibular implant prostheses on the oral health-related quality of life in partially and completely edentulous patients. Clin Oral Implants Res. 2016 Jul;27(7):904-9. doi: 10.1111/clr.12657. Epub 2015 Jul 14.
  PMID: 26173463
  responsible party type: Principal Investigator
  investigator affiliation: Ain Shams University
  investigator full name: Samar El Desouki
  investigator title: Master student
  provided document: 