Role of Plasma Rich Growth Factor in Repair Primary Cleft Palate

NCT06889181 | Not Yet Recruiting DMC

• 1 other identifier: Cleft palate - Omfs338
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cleft Palate; Plasma Rich in Growth Factors

Keywords

cleft palate; plasma rich growth factor; healing

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• wound healing assesment

  2 years

• the occurrence of oronasal fistula

  first day after surgery to end of treatment at 3 months

Study Arms (2)

plasma rich growth factor (PRGF) (intervention or study group)

ACTIVE COMPARATOR

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)

placebo (control group)

PLACEBO COMPARATOR

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

Interventions

Plasma Rich in Growth Factors (PRGF) OTHER

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

plasma rich growth factor (PRGF) (intervention or study group)

Placebo OTHER

primary closing cleft palate-isolated cleft palate

placebo (control group)

Eligibility Criteria

• Age: 6 Months - 18 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry, Cairo University

Manial, Cairo Governorate, Egypt

Location

MeSH Terms

Conditions

Cleft Palate

Interventions

Intercellular Signaling Peptides and Proteins

Condition Hierarchy (Ancestors)

Jaw Abnormalities; Jaw Diseases; Musculoskeletal Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Stomatognathic Diseases; Mouth Abnormalities; Mouth Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single blinded study. Blinding to the patient will be ensured by masking the instruments during the follow up. The patient will be informed of the steps of the follow up (as mentioned in the consent form) without getting into details of the method of follow up.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer

Model Details: Participants will be randomly assigned to either control or study group in the ratio of 1:1 using random number table.

Study Record Dates

• First Submitted: March 7, 2025
• First Posted: March 21, 2025
• Study Start: April 1, 2025
• Primary Completion: July 30, 2025
• Study Completion (Estimated): June 30, 2027
• Last Updated: March 21, 2025

Record last verified: 2025-03

Locations

EG (1)