Role of Plasma Rich Growth Factor in Repair Primary Cleft Palate

Not Applicable

Not yet recruiting

• Conditions: Cleft Palate; Plasma Rich in Growth Factors

• Registration Number: NCT06889181
• Lead Sponsor: Cairo University

Brief Summary

Does the plasma-rich growth factor (PRGF) with primary cleft palate repair accelerate wound healing and prevent post-operative oronasal fistula occurrence?

Detailed Description

The primary objective is to assess and evaluate the improvement of wound healing (edema at 5th day post operatively) as a primary outcome, and secondary objective is to assess and evaluate the wound closure and the decreasing of the occurrence of the oronasal fistula as a secondary outcome among children with cleft palate, using plasma rich growth factor between nasal mucosa and palatal mucosa

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-07
• Study First Submitted QC: 2025-03-16
• Last Update Submitted: 2025-03-16
• Study First Posted: 2025-03-21
• Last Update Posted: 2025-03-21
• Study Start: 2025-04-01
• Primary Completion: 2025-07-30
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• systemically healthy patients (American Society of Anesthesiologists -ASA I and II); not older than 6-18 months
• Patients with primary non-syndromic isolated cleft palate
• Apprehensive to be in the study.

Exclusion Criteria

• Patients with recurrent palatal fistula
• Existence of syndromic cleft palate
• Blood diseases and platelet disorders (hematological disease)
• Systematic disease radiotherapy or chemotherapy for malignancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
wound healing assesment (edema at 5th day post operatively)	first day after surgery, 3rd day, and 5th day	clinical records, percentage of persistence of edema number of participants with percentage of persisting of edema

Secondary Outcome Measures

Name	Time	Method
wound healing assesment	2 years	clinical records, counting days for healing as healing by days till closure
the occurrence of oronasal fistula	first day after surgery to end of treatment at 3 months	clinical records, yes/no Postoperative complications; mainly oronasal fistula by; clinical observation: inspection, clinical signs: regurgitation of food or drink

Trial Locations

Locations (1)

Faculty of Dentistry, Cairo University; 🇪🇬 Manial, Cairo, Egypt