Allogenic Bone Block for Oro-Antral Communication Closure for Subsequent Implant Placement (CAD-CAM)

May 17, 2026 updated by: mona samy sheta, Tanta University

Novel Application of CAD-CAM Designed Allogenic Bone Block in Oro-Antral Communication Closure for Subsequent Implant Placement: Radiographic and Histological Analysis

13 patients will be included in this study with a badly destructed upper molar indicated for extraction. Cone beam computerized tomography images revealed the presence of a large bone defect associated with oro-antral communication with the maxillary sinus. after extraction, The prefabricated allogenic scaffold will be seated. then 6 months later, implant will be inserted.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

13 patients will be included in this study with a badly destructed upper molar indicated for extraction. Cone beam computerized tomography images revealed the presence of a large bone defect associated with oro-antral communication with the maxillary sinus. : Extraction will be performed atraumatically using a piezotome surgical motor with an extraction kit. After removal of tooth, oro-antral communication will be verified .The prefabricated CAD-CAM allogenic bone will be seated and covered with nonporous d-PTFE membrane which was secured with simple interrupted sutures. After 6 months, a new CBCT scan will be performed. A mucoperiosteal flap will be reflected ,and a bone biopsy will be taken using a trephine bur. Under strictly aseptic circumstances, the selected implant will be inserted

Study Type

Interventional

Enrollment (Estimated)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Tanta, Egypt, 3111
        • Faculty of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • ≥ 20 badly destructed upper molar indicated for extraction CBCT revealed the presence of a large bone defect associated with oro-antral communication with the maxillary sinus

Exclusion Criteria:

  • any systemic disesse affect healing heavy smoker sinus disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: a badly destructed upper molar indicated for extraction. Cone beam computerized tomography images re
a badly destructed upper molar indicated for extraction. Cone beam computerized tomography images revealed the presence of a large bone defect associated with oro-antral communication with the maxillary sinus. Extraction will be performed atraumatically using a piezotome surgical motor with an extraction kit. After removal of tooth, oro-antral communication will be verified .The prefabricated scaffold will be seated and covered with nonporous d-PTFE membrane. after 6 months, a bone biopsy will be taken using a trephine bur. Under strictly aseptic circumstances, the selected implant will be inserted.
Device: Extraction will be performed atraumatically using a piezotome surgical motor with an extraction kit
Extraction will be performed atraumatically using a piezotome surgical motor with an extraction kit. After removal of tooth, oro-antral communication will be verified .The prefabricated CAD-CAM Allogenic bone will be seated and covered with nonporous d-PTFE membrane

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the integration of graft
Time Frame: 6 months
CBCT
6 months
histological analysis of graft
Time Frame: 6 months
histomorphometric analysis
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Investigators

  • Principal Investigator: rehab ghouraba, professor, Tanta University
  • Principal Investigator: mohamed helal, lecturer, Tanta University
  • Principal Investigator: aya alsherif, lecturer, Tanta University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 20, 2025

Primary Completion (Estimated)

October 25, 2026

Study Completion (Estimated)

November 30, 2026

Study Registration Dates

First Submitted

May 17, 2026

First Submitted That Met QC Criteria

May 17, 2026

First Posted (Actual)

May 22, 2026

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 17, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 456789

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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