NCT07066293

Brief Summary

The aim of this study is to evaluate using Sticky Bone grafting combined with concentrated growth factor membrane for repair of unilateral alveolar cleft.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 15, 2022

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 12, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 4, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 15, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 2, 2025

Completed
Last Updated

February 3, 2026

Status Verified

July 1, 2025

Enrollment Period

2.2 years

First QC Date

July 4, 2025

Last Update Submit

January 30, 2026

Conditions

Unilateral Alveolar Cleft of Maxilla

Keywords

alveolar cleftsticky boneconcentrated growth factorvolumetric assessmentbone mineral density

Outcome Measures

Primary Outcomes (5)

  • inflammation

    mild, moderate, severe

    1 month

  • nasal regurgitation

    Yes or No

    1 month

  • fistula recurrence

    positive or negative

    1 month

  • bone graft volume

    soft ware

    1 month

  • bone mineral density

    soft ware

    1 month

Secondary Outcomes (2)

  • bone graft volume

    9 months

  • bone mineral density

    9 months

Study Arms (1)

Sticky Bone grafting with concentrated growth factor membrane for unilateral alveolar cleft

EXPERIMENTAL

This will include 10 patients in whom unilateral alveolar cleft will be repaired using sticky bone grafting combined with concentrated growth factor membrane

Procedure: Unilateral alveolar cleft repair

Interventions

Unilateral alveolar cleft repairPROCEDURE

10 patients in whom unilateral alveolar cleft will be repaired using sticky bone grafting combined with concentrated growth factor membrane

Sticky Bone grafting with concentrated growth factor membrane for unilateral alveolar cleft

Eligibility Criteria

Age13 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patients with unilateral alveolar clefts requiring repair.
  • patients free from any systemic disease that may affect normal healing of bone.
  • patients at an age older than 12 years

You may not qualify if:

  • Bilateral alveolar clefts.
  • Immunocompromised patients.
  • Syndromic patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, Tanta University

Tanta, 31527, Egypt

Location

Study Officials

  • Omnia M Saber

    Faculty of Dentistry, Tanta University, Egypt

    PRINCIPAL INVESTIGATOR

  • Mohamed S Khedr, Prof

    Faculty of Dentistry, Tanta University, Egypt

    PRINCIPAL INVESTIGATOR

  • Ahmed M Elshareef, Ass prof

    Faculty of Dentistry, Tanta University, Egypt

    PRINCIPAL INVESTIGATOR

  • Maram N Breshah, Lecturer

    Faculty of Dentistry, Tanta University, Egypt

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Oral & Maxillofacial Surgery

Study Record Dates

First Submitted

July 4, 2025

First Posted

July 15, 2025

Study Start

November 15, 2022

Primary Completion

February 12, 2025

Study Completion

October 2, 2025

Last Updated

February 3, 2026

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)