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UWD: Ultra-wide Diameter Implants in Mandibular Molars

Sponsor
Abdelrahman Elshahawy (Other)
Overall Status
Completed
CT.gov ID
NCT05972447
Collaborator
(none)
12
Enrollment
1
Location
1
Arm
9.4
Actual Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The goal of this [clinical trial] is to [To evaluate both the clinical and radiographical outcome on osteointegration and peri-implant bone density when using ultra wide diameter implant placed immediately in molar extraction socket]

Condition or Disease Intervention/Treatment Phase
  • Procedure: Immediate implant placement of Ultrawide diameter dental implants
 N/A

Detailed Description

the aim of this study is to evaluate the clinical and radiographical outcomes on osseointegration and peri-implant bone density when using 12 ultrawide diameter dental implants placed immediately in 12 patients after atraumatic extraction of non-restorable mandibular molars without raising a flap or using bone grafts.

Study Design

Study Type:
Interventional
Actual Enrollment :
12 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Evaluation of Immediately Placed Ultra-wide Diameter Implant Placed in Mandibular Molars
Actual Study Start Date :
May 20, 2021
Actual Primary Completion Date :
Jan 12, 2022
Actual Study Completion Date :
Mar 3, 2022

Arms and Interventions

Arm Intervention/Treatment
Other: non-restorable mandibular molar teeth

patients with non restorable mandibular molar teeth without any periapical pathosis to be extracted and implanted immediately using ultrawide diameter dental implants

Procedure: Immediate implant placement of Ultrawide diameter dental implants
immediate placement of ultrawide diameter dental implants in a fresh extraction socket of mandibular molar teeth
Other Names:
  • Ultrawide diameter dental implants

    		•

    Outcome Measures

    Primary Outcome Measures

    1. the mean value of implant stability [up to 6months]

      The implant stability was measured by implant stability meter (Osstell™) immediately postoperative and at 6 months.

    2. the mean value of peri-implant bone density [up to 9 months]

      Radiographic evaluation of the bone density around each implant was done using OnDemand3D™.

    3. the mean value of Marginal bone loss [up to 9months]

      marginal bone levels were calculated from the reconstructed corrected sagittal views by drawing a line parallel to the implant serration extending from the crestal bone to the apical end of the implant. Average readings of the two sides at each interval were calculated and tabulated for statistical analysis.

    4. the mean of peri-implant probing depth [up to 9 months]

      Probing depth was assessed according to Gallagher and Silver Probing pocket depth refers to the distance between the gingival margin and the bottom of the pocket

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 40 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    Adult patients ranging from 20-40 years.

    • Adequate bone beyond teeth apices without jeopardizing any anatomical structure.

    • Non-restorable mandibular molar teeth.

    • Available bone with adequate width and buccolingual dimensions.

    • Peri-implant bone defect should be 2mm or lesser.

    Exclusion Criteria:

    • Smokers.

    • Medically compromised patients like uncontrolled diabetes and coagulation disorders.

    • Tooth with periapical pathosis or bony defects.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Alexandria University Alexandria Egypt 20200

    Sponsors and Collaborators

    • Abdelrahman Elshahawy

    Investigators

    • Study Director: Gaafar N Elhalawani, Alexandria University

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Abdelrahman Elshahawy, principle investigator, Alexandria University
    ClinicalTrials.gov Identifier:
    NCT05972447
    Other Study ID Numbers:
    • 0210-01/2021
    First Posted:
    Aug 2, 2023
    Last Update Posted:
    Aug 2, 2023
    Last Verified:
    Jul 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Abdelrahman Elshahawy, principle investigator, Alexandria University
    UWD implants

    Study Results

    No Results Posted as of Aug 2, 2023