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/NCT06038487</url>
    </required_header>
    <id_info>
      <org_study_id>STUDY20221174</org_study_id>
      <nct_id>NCT06038487</nct_id>
    </id_info>
    <brief_title>Immediate Versus Delayed Loading of Maxillary Overdenture Implants</brief_title>
    <official_title>Immediate Versus Delayed Loading of Maxillary Overdenture Implants</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Case Western Reserve University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Institut Straumann AG</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>Case Western Reserve University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of the study is to evaluate the radiographic, clinical and patient-centered&#xD;
        outcomes of implant-retained immediately-loaded maxillary complete dentures in comparison to&#xD;
        delayed loading approach by primarily evaluating radiographic bone loss of dental implants&#xD;
        placed in the maxilla over 36 months&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The primary objective of this study is to evaluate radiographically at 6, 12, 24, and 36&#xD;
        months post-loading the performance of the BLX Roxolid™ implants placed using a flapless&#xD;
        guided surgery and immediately loaded with a maxillary overdenture versus delayed loading 3&#xD;
        months after surgical placement. The outcome will be evaluated using peri-implant,&#xD;
        radiographic bone level changes from baseline to 6, 12, 24, and 36 months post-implant&#xD;
        placement. The secondary objectives include evaluation of the condition of the peri-implant&#xD;
        mucosa (pocket depth and bleeding on probing); Implant survival at 6, 12, 24, and 36 months;&#xD;
        The nature and the frequency of surgical and prosthetic complications; Patient-centred&#xD;
        outcomes (OHIP 14). An initial evaluation will be conducted to determine whether a patient&#xD;
        meets the study inclusion criteria. This evaluation will include medical history, clinical&#xD;
        examination, and radiographic examination (OPT). A pre-operative prosthetic evaluation of the&#xD;
        existing prostheses will be made to establish their quality and the need for a new set of&#xD;
        complete dentures before the implant placement. The maxillary denture will be used as a&#xD;
        radiographic guide for the pre-treatment CBCT assessment. The tridimensional image obtained&#xD;
        with the CBCT will be used for the surgical planning of the implant positioning using a&#xD;
        dedicated implant planning software (coDiagnostix, Dental Wings Gbmh, Chemniz Germany)) and a&#xD;
        stereo-lithographic surgical guide will obtained using a 3D printer (Formlab 3B, Formlabs&#xD;
        Inc. Somerville MA.). The implants will be inserted under local anesthesia, following&#xD;
        consumption of prophylactic antibiotic medications consisting of 2 grams of amoxicillin 1&#xD;
        hour before the surgical procedure (Esposito et al 2010). If the patient is allergic to&#xD;
        penicillin or penicillin derivatives, azithromycin or other classes of antibiotics will be&#xD;
        administered according to ADA guidelines. The implant placement will be performed using the&#xD;
        stereo-lithographic surgical guide. A small crestal incision and a minimal flap elevation&#xD;
        will be performed in the location of the implant sites. The osteotomy site will be prepared&#xD;
        following the drilling sequence provided by the manufacturer's surgical manual. The implant&#xD;
        will be placed, and the maximum value of insertion torque (peak of insertion torque, IT) will&#xD;
        be measured during the seating of the most coronal implant threads using the surgical unit&#xD;
        (W&amp;H, Burmoos, Austria) and recorded as 20, 30, 40, 50 N/cm IT category. In case of IT lower&#xD;
        than 20 N/cm the patient will be excluded from the study and the implant treatment will be&#xD;
        completed following the standard delayed protocol. After implant placement, the patient will&#xD;
        be randomly allocated to the test or control group. BLX Roxolid dental implants will be used,&#xD;
        and length and size will be chosen based on the available bone volume. A minimum amount of&#xD;
        bone at the 2nd premolar position to house a 3.5 x 10 mm BLX-Roxolid will be required. The&#xD;
        patient will be randomly assigned to have their implants immediately loaded or conventionally&#xD;
        loaded/delayed. The randomization will be computer-generated and your assignment will be&#xD;
        placed in a sealed envelope. On the day of surgery, after the implants are placed, we will&#xD;
        open the envelope to see which group the patient has been assigned to. If assigned to the&#xD;
        test group, the denture will be immediately connected to the implants. The abutment screw&#xD;
        will be torqued at 15 Ncm. The Novalok cap attachments will be picked up intra-orally using&#xD;
        cold-curing resin. To avoid contact of the resin with the surgical wound, a circular portion&#xD;
        of a sterile rubber dam sheet will be adapted on the cap attachment once placed on the&#xD;
        abutment during the pickup procedure. Occlusion is then checked and adjusted if necessary as&#xD;
        well as the adaptation on the residual ridges and the patient is dismissed. If assigned to&#xD;
        the control group, a cover screw will be seated on the implants and the flap will be sutured&#xD;
        for submerged healing. After 3 months of healing the implants will be exposed and connected&#xD;
        to the prosthesis following the same prosthetic protocol as described for the test group. The&#xD;
        abutment screw will be torqued at 35 Ncm. As per post-surgical instructions, the patients&#xD;
        will be asked not to brush the operated areas and to rinse instead with 0,12% chlorhexidine&#xD;
        solution twice a day for 1 minute for 14 days. Pain control is provided with 400 mg&#xD;
        ibuprofen, as needed. A soft diet is recommended for 2 weeks. The patients in the test group&#xD;
        will be instructed not to remove the prosthesis for one week. The patients in the control&#xD;
        group will be asked not to wear the denture for 7 days. Patients will be recalled at 1, 2, 4,&#xD;
        12 weeks, and 6, 12, 24, and 36 months after surgery. At the post-operative visit occlusion&#xD;
        will be checked, as well as stability and retention of the prostheses and the need for any&#xD;
        prosthetic maintenance. At 12 weeks the test group patient will have the abutment screw&#xD;
        torqued at 35 Ncm. The control group patient will have the implant exposed and connected to&#xD;
        Novalock using a 35 Ncm torque. Periapical radiographs will be taken at abutment connection&#xD;
        and 6, 12, 24, 36 months visit by paralleling technique using a Rinnâ (Dentsply Rinn, Elgin,&#xD;
        Illinois, USA) film holder. The film holder will be indexed on the attachment so that the&#xD;
        film position can be reproduced for the follow-up radiographs. All patient complaints or any&#xD;
        complications resulting from a change in health status from baseline or any implant-related&#xD;
        complications such as pain, paraesthesia, or peri-implant infection will be recorded as an&#xD;
        adverse event in the CRF and will be monitored until the condition is resolved. OHIP-14&#xD;
        questionnaire will be administered at baseline, at 4 weeks post-surgery, and months 6, 12,&#xD;
        24, and 36 months.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">February 1, 2023</start_date>
    <completion_date type="Anticipated">February 1, 2028</completion_date>
    <primary_completion_date type="Anticipated">February 1, 2025</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>Double (Care Provider, Investigator)</masking>
      <masking_description>Every patient will be given a participant identification number. An independent investigator, not involved with patient treatment, will generate the allocation list. Computer software will be used to randomize the participant identification numbers into one of the two groups. This information will be concealed in sealed opaque envelopes, which will be open after implants are placed. Neither the surgeon, nor the patient will be aware of the group assignment until after implant insertion.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Radiographic bone level of changes of implants</measure>
      <time_frame>36 months</time_frame>
      <description>The primary objective of this study is to evaluate radiographically at 6, 12, 24 and 36 months post-loading the performance of the BLX Roxolid™ implants placed using a flapless guided surgery and immediately loaded with a maxillary overdenture versus delayed loading 3 months after surgical placement. The outcome will be evaluated using peri-implant, radiographic bone level changes from baseline to 6, 12, 24 and 36 months post implant placement.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Peri-implant mucosa</measure>
      <time_frame>36 months</time_frame>
      <description>Condition of the peri-implant mucosa (pocket depth and bleeding on probing)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Implant survival</measure>
      <time_frame>36 months</time_frame>
      <description>Implant survival at 6, 12, 24 and 36 months.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Complications</measure>
      <time_frame>36 months</time_frame>
      <description>The nature and the frequency of surgical and prosthetic complications</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient-centered outcomes</measure>
      <time_frame>36 months</time_frame>
      <description>Patient-centered outcomes according to Oral Health Impact Profile-14 (OHIP 14)</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">18</enrollment>
    <condition>Implant Complication</condition>
    <arm_group>
      <arm_group_label>Test - IL ( Immediate Loading)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The maxillary denture will be immediately connected to the implants on the day of the surgery</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control - DL ( Delayed Loading)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>At the time of surgery, the cover screw will be seated on the implants and the flap will be sutured for a submerged healing. After 3 months of healing the implants will be exposed and connected to the prosthesis following the same prosthetic protocol as the test group.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Immediate loading of maxillary implant overdenture</intervention_name>
      <description>The denture will be immediately connected to the implants. The abutment screw will be torqued at 15 Ncm. The Novaloc cap attachments will be picked up intra-orally using cold curing resin. To avoid contact of the resin with the surgical wound, a circular portion of a sterile rubber dam sheet will be adapted on the cap attachment once placed on the abutment during the pickup procedure. Occlusion is then checked and adjusted if necessary as well as the adaptation on the residual ridges and the patient dismissed. The patients in the test group will be instructed not to remove the prosthesis for one week.</description>
      <arm_group_label>Test - IL ( Immediate Loading)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Delayed loading of maxillary implant overdenture</intervention_name>
      <description>A cover screw will be seated on the implants and the flap will be sutured for a submerged healing. After 3 months of healing the implants will be exposed and connected to the prosthesis following the same prosthetic protocol as described for the test group. The abutment screw will be torqued at 35 Ncm. As post-surgical instructions, the patients will be asked not to brush the operated areas and to rinse instead with 0,12% chlorhexidine solution twice a day for 1 minute for 14 days. Pain control is provided with 400 mg ibuprofen, as needed. Soft diet is recommended for 2 weeks. The patients in the control group will be asked not to wear the denture for 7 days.</description>
      <arm_group_label>Control - DL ( Delayed Loading)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Males and females must be at least ≥ 21 years of age&#xD;
  &#xD;
            2. Fully edentulous maxilla&#xD;
  &#xD;
            3. The implant site has to be healed for at least 4 months after extraction&#xD;
  &#xD;
            4. Wearing complete dentures deemed adequate&#xD;
  &#xD;
            5. Orthopantomogram available (OPT)&#xD;
  &#xD;
            6. Adequate amount of bone at least at the 2nd premolar position to house at minimum a&#xD;
               3.5 x 10 mm BLX-Roxolid implant&#xD;
  &#xD;
            7. No bone grafting required&#xD;
  &#xD;
            8. Implant IT ≥ 20 N/cm&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Conditions requiring chronic routine prophylactic use of antibiotics&#xD;
  &#xD;
            2. Conditions requiring prolonged use of steroids&#xD;
  &#xD;
            3. History of leukocyte dysfunction and deficiencies&#xD;
  &#xD;
            4. Bleeding disorders&#xD;
  &#xD;
            5. History of neoplastic disease requiring use of radiation or chemotherapy&#xD;
  &#xD;
            6. Metabolic bone disorders&#xD;
  &#xD;
            7. Uncontrolled endocrine disorder&#xD;
  &#xD;
            8. Use of any investigational drug or device within the 30-day period prior to implant&#xD;
               surgery&#xD;
  &#xD;
            9. Vaping, Tobacco Chewing or Smoking more than 10 cigarettes a day&#xD;
  &#xD;
           10. Alcoholism or drug abuse&#xD;
  &#xD;
           11. Patient infected with HIV&#xD;
  &#xD;
           12. Condition or circumstances, in the opinion of the investigator, which would prevent&#xD;
               completion of study participation or interfere with analysis of study results, such as&#xD;
               as history of non-compliance, unreliability.&#xD;
  &#xD;
           13. Local inflammation including untreated periodontitis&#xD;
  &#xD;
           14. Mucosal disease such as erosive lichen planus&#xD;
  &#xD;
           15. History of local irradiation therapy&#xD;
  &#xD;
           16. Osseous lesion&#xD;
  &#xD;
           17. Severe bruxism and clenching habits&#xD;
  &#xD;
           18. Active infection with suppuration or fistula track&#xD;
  &#xD;
           19. Persistent intraoral infection&#xD;
  &#xD;
           20. Lack of primary stability &lt;20Ncm. In this instance, the patient must be withdrawn and&#xD;
               treated according to the standard protocol.&#xD;
  &#xD;
           21. Inadequate oral hygiene or unmotivated home care.&#xD;
  &#xD;
           22. Bone grafting needed&#xD;
  &#xD;
           23. Inadequate bone volume for implants insertion as measured on the pre-treatment cone&#xD;
               beam computed tomography (CBCT).&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>21 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Gian P Schincaglia, DDS, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Case Western Reserve University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Elysha Pomerantz, DMD</last_name>
      <phone>216-368-4412</phone>
      <email>emp142@case.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>Case Western Reserve University Department of Periodontics</name>
        <address>
          <city>Cleveland</city>
          <state>Ohio</state>
          <zip>44106</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Gian Pietro Schincaglia, DDS, PhD</last_name>
        <phone>216-368-4412</phone>
        <email>gxs486@case.edu</email>
      </contact>
      <contact_backup>
        <last_name>Elysha Pomerantz, DMD</last_name>
        <phone>216-368-4412</phone>
        <email>emp142@case.edu</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>September 8, 2023</study_first_submitted>
    <study_first_submitted_qc>September 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 8, 2023</last_update_submitted>
    <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Case Western Reserve University</investigator_affiliation>
      <investigator_full_name>Gian Schincaglia</investigator_full_name>
      <investigator_title>Professor, Chair and Graduate Program Director</investigator_title>
    </responsible_party>
    <keyword>Implant Overdenture</keyword>
    <keyword>Immediate loading</keyword>
    <keyword>Delayed loading</keyword>
    <keyword>Maxillary Overdenture</keyword>
    <keyword>Novaloc Retention System</keyword>
    <keyword>Guided Implants</keyword>
    <keyword>Immediate vs Delayed loading</keyword>
    <keyword>Implant-supported overdenture</keyword>
    <!-- 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/NCT06038487
  org study id: STUDY20221174
  nct id: NCT06038487
  lead sponsor: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of the study is to evaluate the radiographic, clinical and patient-centered
        outcomes of implant-retained immediately-loaded maxillary complete dentures in comparison to
        delayed loading approach by primarily evaluating radiographic bone loss of dental implants
        placed in the maxilla over 36 months
  The primary objective of this study is to evaluate radiographically at 6, 12, 24, and 36
        months post-loading the performance of the BLX Roxolid™ implants placed using a flapless
        guided surgery and immediately loaded with a maxillary overdenture versus delayed loading 3
        months after surgical placement. The outcome will be evaluated using peri-implant,
        radiographic bone level changes from baseline to 6, 12, 24, and 36 months post-implant
        placement. The secondary objectives include evaluation of the condition of the peri-implant
        mucosa (pocket depth and bleeding on probing); Implant survival at 6, 12, 24, and 36 months;
        The nature and the frequency of surgical and prosthetic complications; Patient-centred
        outcomes (OHIP 14). An initial evaluation will be conducted to determine whether a patient
        meets the study inclusion criteria. This evaluation will include medical history, clinical
        examination, and radiographic examination (OPT). A pre-operative prosthetic evaluation of the
        existing prostheses will be made to establish their quality and the need for a new set of
        complete dentures before the implant placement. The maxillary denture will be used as a
        radiographic guide for the pre-treatment CBCT assessment. The tridimensional image obtained
        with the CBCT will be used for the surgical planning of the implant positioning using a
        dedicated implant planning software (coDiagnostix, Dental Wings Gbmh, Chemniz Germany)) and a
        stereo-lithographic surgical guide will obtained using a 3D printer (Formlab 3B, Formlabs
        Inc. Somerville MA.). The implants will be inserted under local anesthesia, following
        consumption of prophylactic antibiotic medications consisting of 2 grams of amoxicillin 1
        hour before the surgical procedure (Esposito et al 2010). If the patient is allergic to
        penicillin or penicillin derivatives, azithromycin or other classes of antibiotics will be
        administered according to ADA guidelines. The implant placement will be performed using the
        stereo-lithographic surgical guide. A small crestal incision and a minimal flap elevation
        will be performed in the location of the implant sites. The osteotomy site will be prepared
        following the drilling sequence provided by the manufacturer's surgical manual. The implant
        will be placed, and the maximum value of insertion torque (peak of insertion torque, IT) will
        be measured during the seating of the most coronal implant threads using the surgical unit
        (W&H, Burmoos, Austria) and recorded as 20, 30, 40, 50 N/cm IT category. In case of IT lower
        than 20 N/cm the patient will be excluded from the study and the implant treatment will be
        completed following the standard delayed protocol. After implant placement, the patient will
        be randomly allocated to the test or control group. BLX Roxolid dental implants will be used,
        and length and size will be chosen based on the available bone volume. A minimum amount of
        bone at the 2nd premolar position to house a 3.5 x 10 mm BLX-Roxolid will be required. The
        patient will be randomly assigned to have their implants immediately loaded or conventionally
        loaded/delayed. The randomization will be computer-generated and your assignment will be
        placed in a sealed envelope. On the day of surgery, after the implants are placed, we will
        open the envelope to see which group the patient has been assigned to. If assigned to the
        test group, the denture will be immediately connected to the implants. The abutment screw
        will be torqued at 15 Ncm. The Novalok cap attachments will be picked up intra-orally using
        cold-curing resin. To avoid contact of the resin with the surgical wound, a circular portion
        of a sterile rubber dam sheet will be adapted on the cap attachment once placed on the
        abutment during the pickup procedure. Occlusion is then checked and adjusted if necessary as
        well as the adaptation on the residual ridges and the patient is dismissed. If assigned to
        the control group, a cover screw will be seated on the implants and the flap will be sutured
        for submerged healing. After 3 months of healing the implants will be exposed and connected
        to the prosthesis following the same prosthetic protocol as described for the test group. The
        abutment screw will be torqued at 35 Ncm. As per post-surgical instructions, the patients
        will be asked not to brush the operated areas and to rinse instead with 0,12% chlorhexidine
        solution twice a day for 1 minute for 14 days. Pain control is provided with 400 mg
        ibuprofen, as needed. A soft diet is recommended for 2 weeks. The patients in the test group
        will be instructed not to remove the prosthesis for one week. The patients in the control
        group will be asked not to wear the denture for 7 days. Patients will be recalled at 1, 2, 4,
        12 weeks, and 6, 12, 24, and 36 months after surgery. At the post-operative visit occlusion
        will be checked, as well as stability and retention of the prostheses and the need for any
        prosthetic maintenance. At 12 weeks the test group patient will have the abutment screw
        torqued at 35 Ncm. The control group patient will have the implant exposed and connected to
        Novalock using a 35 Ncm torque. Periapical radiographs will be taken at abutment connection
        and 6, 12, 24, 36 months visit by paralleling technique using a Rinnâ (Dentsply Rinn, Elgin,
        Illinois, USA) film holder. The film holder will be indexed on the attachment so that the
        film position can be reproduced for the follow-up radiographs. All patient complaints or any
        complications resulting from a change in health status from baseline or any implant-related
        complications such as pain, paraesthesia, or peri-implant infection will be recorded as an
        adverse event in the CRF and will be monitored until the condition is resolved. OHIP-14
        questionnaire will be administered at baseline, at 4 weeks post-surgery, and months 6, 12,
        24, and 36 months.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Care Provider, Investigator)
  masking description: Every patient will be given a participant identification number. An independent investigator, not involved with patient treatment, will generate the allocation list. Computer software will be used to randomize the participant identification numbers into one of the two groups. This information will be concealed in sealed opaque envelopes, which will be open after implants are placed. Neither the surgeon, nor the patient will be aware of the group assignment until after implant insertion.
  measure: Radiographic bone level of changes of implants
  time frame: 36 months
  description: The primary objective of this study is to evaluate radiographically at 6, 12, 24 and 36 months post-loading the performance of the BLX Roxolid™ implants placed using a flapless guided surgery and immediately loaded with a maxillary overdenture versus delayed loading 3 months after surgical placement. The outcome will be evaluated using peri-implant, radiographic bone level changes from baseline to 6, 12, 24 and 36 months post implant placement.
  measure: Peri-implant mucosa
  time frame: 36 months
  description: Condition of the peri-implant mucosa (pocket depth and bleeding on probing)
  measure: Implant survival
  time frame: 36 months
  description: Implant survival at 6, 12, 24 and 36 months.
  measure: Complications
  time frame: 36 months
  description: The nature and the frequency of surgical and prosthetic complications
  measure: Patient-centered outcomes
  time frame: 36 months
  description: Patient-centered outcomes according to Oral Health Impact Profile-14 (OHIP 14)
  arm group label: Test - IL ( Immediate Loading)
  arm group type: Experimental
  description: The maxillary denture will be immediately connected to the implants on the day of the surgery
  arm group label: Control - DL ( Delayed Loading)
  arm group type: Active Comparator
  description: At the time of surgery, the cover screw will be seated on the implants and the flap will be sutured for a submerged healing. After 3 months of healing the implants will be exposed and connected to the prosthesis following the same prosthetic protocol as the test group.
  intervention type: Procedure
  intervention name: Immediate loading of maxillary implant overdenture
  description: The denture will be immediately connected to the implants. The abutment screw will be torqued at 15 Ncm. The Novaloc cap attachments will be picked up intra-orally using cold curing resin. To avoid contact of the resin with the surgical wound, a circular portion of a sterile rubber dam sheet will be adapted on the cap attachment once placed on the abutment during the pickup procedure. Occlusion is then checked and adjusted if necessary as well as the adaptation on the residual ridges and the patient dismissed. The patients in the test group will be instructed not to remove the prosthesis for one week.
  arm group label: Test - IL ( Immediate Loading)
  intervention type: Procedure
  intervention name: Delayed loading of maxillary implant overdenture
  description: A cover screw will be seated on the implants and the flap will be sutured for a submerged healing. After 3 months of healing the implants will be exposed and connected to the prosthesis following the same prosthetic protocol as described for the test group. The abutment screw will be torqued at 35 Ncm. As post-surgical instructions, the patients will be asked not to brush the operated areas and to rinse instead with 0,12% chlorhexidine solution twice a day for 1 minute for 14 days. Pain control is provided with 400 mg ibuprofen, as needed. Soft diet is recommended for 2 weeks. The patients in the control group will be asked not to wear the denture for 7 days.
  arm group label: Control - DL ( Delayed Loading)
  criteria: 
  gender: All
  minimum age: 21 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Gian P Schincaglia, DDS, PhD
  role: Principal Investigator
  affiliation: Case Western Reserve University
  last name: Elysha Pomerantz, DMD
  phone: 216-368-4412
  email: emp142@case.edu
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: Case Western Reserve University
  investigator full name: Gian Schincaglia
  investigator title: Professor, Chair and Graduate Program Director