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Sticky Bone Grafting With Concentrated Growth Factor Membrane for Repair of Unilateral Alveolar Cleft

Evaluation of Using Sticky Bone Grafting Combined With Concentrated Growth Factor Membrane for Repair of Unilateral Alveolar Cleft

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07066293
Enrollment
10
Registered
2025-07-15
Start date
2022-11-15
Completion date
2025-10-02
Last updated
2026-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Unilateral Alveolar Cleft of Maxilla

Keywords

alveolar cleft, sticky bone, concentrated growth factor, volumetric assessment, bone mineral density

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.

Detailed description

This study will be carried out on ten patients with unilateral alveolar clefts, The patients will be recieved, clinically& radiographically examined and managed at Oral & Maxillofacial Surgery Department, Faculty of Dentistry, Tanta University. Preoperative evaluation: Clinical evaluation will include presence of oronasal fistulas, nasal regurgitation and Presence of erupting teeth in cleft. .Preoperative cone beam computed tomography (CBCT) scans will be analyzed to measure alveolar cleft dimensions and the total cleft defect volume will be calculated. Surgical technique: Under general anesthesia, mucoperiosteal flaps will be raised along the cleft margins, exposing the defect. The nasal lining will be sutured with 4/0 Vicryl, followed by the application of a concentrated growth factor (CGF) membrane to cover the nasal mucosa. The sticky bone graft will be packed tightly into the cleft, ensuring complete defect filling. A CGF membrane will be then placed over the graft to enhance stability and healing. The flaps will be sutured using tension-free interrupted 3/0 Vicryl sutures to ensure full coverage of the graft. Postoperative evaluation: The patients will be evaluated over a nine-months follow-up period clinically at intervals of 1st & 2nd weeks, then 1st ,3rd and 9th months for healing parameters such as infection, wound dehiscence, recurrence of oronasal fistulas, nasal regurgitation and graft exposure & radiographically by using CBCT for assessing graft volume, bone mineral density immediate, 3rd & 9th months postoperatively.

Interventions

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

Sponsors

Tanta University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
13 Years to 30 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* Bilateral alveolar clefts. * Immunocompromised patients. * Syndromic patients.

Design outcomes

Primary

MeasureTime frameDescription
inflammation1 monthmild, moderate, severe
nasal regurgitation1 monthYes or No
fistula recurrence1 monthpositive or negative
bone graft volume1 monthsoft ware
bone mineral density1 monthsoft ware

Secondary

MeasureTime frameDescription
bone graft volume9 monthssoft ware
bone mineral density9 monthssoft ware

Countries

Egypt

Contacts

PRINCIPAL_INVESTIGATOROmnia M Saber

Faculty of Dentistry, Tanta University, Egypt

PRINCIPAL_INVESTIGATORMohamed S Khedr, Prof

Faculty of Dentistry, Tanta University, Egypt

PRINCIPAL_INVESTIGATORAhmed M Elshareef, Ass prof

Faculty of Dentistry, Tanta University, Egypt

PRINCIPAL_INVESTIGATORMaram N Breshah, Lecturer

Faculty of Dentistry, Tanta University, Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026