Role of Plasma Rich Growth Factor in Repair Primary Cleft Palate (PRGF)

Evaluation of the Role of the Plasma-rich Growth Factor (PRGF) with Primary Cleft Palate Repair Versus Primary Cleft Palate Repair in Post-operative Wound Healing and Oronasal Fistula Occurrence, a Randomized Clinical Trial

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

Study Overview

• Status: Not yet recruiting
• Conditions: Cleft Palate; Plasma Rich in Growth Factors
• Intervention / Treatment: Other: Plasma Rich in Growth Factors (PRGF); Other: Placebo

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 Type: Interventional
• Enrollment (Estimated): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo
    • Manial, Cairo, Egypt
      • Faculty of Dentistry, Cairo University
      • Contact: sarah horia, M.Sc.; Phone Number: 00201010014043; Email: sarahhoria@gmail.com
      • Contact: El noman MK El shafie, lecturer; Phone Number: 002001063999203; Email: nomanmust@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: plasma rich growth factor (PRGF) (intervention or study group); plasma rich growth factor (PRGF) intervention or study group Has Surgical procedures "von Langenbeck technique " to repair cleft palate and placing plasma rich growth factors between nasal and palatal tissue then primary closure intraoperatively, then patient will come for follow up visit after surgery, 1st day, 3rd, 5th day and come for follow up visits at 1 week, 1 month and 3 months postoperative	Other: Plasma Rich in Growth Factors (PRGF); using prgf with closing primary cleft palate - isolated cleft palate Minutes before the surgery, 10-20 ml of venous blood from each patient. -The blood is centrifuged to obtain PRGF. -Fixed between nasal and palatal mucosa
Placebo Comparator: placebo (control group); placebo (control group) Has Surgical procedures "von Langenbeck technique " to repair cleft palate primary closure, then patient will come for follow up visit after surgery, 1st day, 3rd, 5th day and come for follow up visits at 1 week, 1 month and 3 months postoperative	Other: Placebo; primary closing cleft palate-isolated cleft palate

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2025
• Primary Completion (Estimated): July 30, 2025
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: March 7, 2025
• First Submitted That Met QC Criteria: March 16, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 16, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: cleft palate; healing; plasma rich growth factor
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Mouth Diseases; Stomatognathic Diseases; Jaw Diseases; Jaw Abnormalities; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Stomatognathic System Abnormalities; Congenital Abnormalities; Mouth Abnormalities; Cleft Palate; Molecular Mechanisms of Pharmacological Action; Mitosis Modulators; Mitogens
• Other Study ID Numbers: Cleft palate - Omfs338

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No