Conventional Flap Versus Vestibular Flap in Bone Augmentation ((RCT))

June 17, 2026 updated by: Piatrece Amgad Wadeea, Cairo University

Assessment of Vestibular Shifted Flap Versus Conventional Flap on Ridge Augmentation in Patients With Anterior Maxillary Bony Deficiency: a Randomized Control Trial

two groups of patients both have alveolar bone deficiency in anterior maxilla, one group will be subjected to khoury bone augmentation with conventional flap the other with vestibular shifted flap

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The procedure begins with preoperative preparation, including patient positioning in a semi supine position with appropriate head support, induction of local anesthesia, and meticulous surgical site sterilization.

  • Full thickness Vestibular flap and 2 horizontal releasing incision are made (Key Concept: The vestibular shifted flap provides additional flap length by translating vestibular mucosa coronally while preserving keratinized tissue and blood supply) in a group and conventional flap in the other group
  • Flap elevation: Full thickness flap in the Donor site
  • Using piezoelectric device, thin cortical bone blocks (1-1.5 mm thick) are harvested.
  • Blocks are carefully shaped into flat "plates."
  • The shell Graft placed, adapted and fixed with microscrews to restore desired horizontal dimension
  • The space between the host bone and the fixed cortical plates is filled with bone particles.
  • Tension free bilayered suturing

Study Type

Interventional

Enrollment (Estimated)

24

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 Contact

Study Contact Backup

Study Locations

  • Egypt
    • Giza Governorate
      • Cairo, Giza Governorate, Egypt, 12613

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

Yes

Description

Inclusion Criteria:

  • Adult patients with horizontal bone defects in anterior maxilla
  • Mixed dentition age (21-75)
  • Good periodontal health
  • Non smokers
  • Both genders males and females will be included

Exclusion Criteria:

  • Uncontrolled systemic disease
  • General contraindications to surgery.
  • Patients participating in other studies, if the present protocol could not be properly followed.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: vestibular flap group
Procedure: vestibular shifted flap for bone augmentation

The procedure begins with preoperative preparation, including patient positioning in a semi supine position with appropriate head support, induction of local anesthesia, and meticulous surgical site sterilization.

  • Full thickness Vestibular flap and 2 horizontal releasing incision are made (Key Concept: The vestibular shifted flap provides additional flap length by translating vestibular mucosa coronally while preserving keratinized tissue and blood supply)
  • Flap elevation: Full thickness flap in the Donor site
  • Using piezoelectric device, thin cortical bone blocks (1-1.5 mm thick) are harvested.
  • Blocks are carefully shaped into flat "plates."

  • The shell Graft placed, adapted and fixed with microscrews to restore desired horizontal dimension

    . • The space between the host bone and the fixed cortical plates is filled with bone particles.

  • Tension free bilayered suturing.
Active Comparator: conventional flap group
Procedure: conventional flap

The procedure begins with preoperative preparation, including patient positioning in a semi supine position with appropriate head support, induction of local anesthesia, and meticulous surgical site sterilization.

  • Full thickness conventional flap and 2 horizontal releasing incision are made
  • Flap elevation Full thickness flap in the Donor site
  • Using piezoelectric device, thin cortical bone blocks (1-1.5 mm thick) are harvested.
  • Blocks are carefully shaped into flat "plates."
  • The shell Graft placed, adapted and fixed with microscrews to restore desired horizontal dimension.
  • The space between the host bone and the fixed cortical plates is filled with bone particles.
  • Tension free bilayered suturing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Horizontal Bone Gain Assessed in millimeters by Cone-Beam Computed Tomography (CBCT)
Time Frame: 6 months
Horizontal bone gain will be evaluated using cone-beam computed tomography (CBCT). Alveolar ridge width will be measured in millimeters (mm) at standardized reference points before the augmentation procedure and at 6 months postoperatively. The outcome will be calculated as the change in ridge width (mm) from baseline to follow-up.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Width of Keratinized Tissue Assessed by Periodontal Probe
Time Frame: 6 months
The width of keratinized tissue will be measured clinically using a calibrated periodontal probe and recorded in millimeters (mm) at baseline and 6 months postoperatively. The outcome will be calculated as the change in keratinized tissue width from baseline to follow-up.
6 months

Collaborators and Investigators

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

Sponsor

Cairo University

Investigators

  • Study Director: Sameh mekhemer, PHD, Mekhemer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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 (Estimated)

August 15, 2026

Primary Completion (Estimated)

June 15, 2027

Study Completion (Estimated)

June 15, 2027

Study Registration Dates

First Submitted

June 15, 2026

First Submitted That Met QC Criteria

June 17, 2026

First Posted (Actual)

June 23, 2026

Study Record Updates

Last Update Posted (Actual)

June 23, 2026

Last Update Submitted That Met QC Criteria

June 17, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • vestibular & conventional flap

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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