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Role of Plasma Rich Growth Factor in Repair Primary Cleft Palate

ConditionsCleft PalatePlasma Rich in Growth Factors
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-18
SponsorCairo University

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

Patients with recurrent palatal fistula

Existence of syndromic cleft palate

Blood diseases and platelet disorders (hematological disease)

Systematic disease radiotherapy or chemotherapy for malignancy

Trial design

Design model

Parallel

Treatments tested in this trial

  • Plasma Rich in Growth Factors (PRGF)

    Other intervention

    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

    Other intervention

    primary closing cleft palate-isolated cleft palate

Treatment groups

36 Participants
are divided into 2 treatment groups
Group A: plasma rich growth factor (PRGF) (intervention or study group)Active comparator 1 intervention
Group B: placebo (control group)Placebo comparator 1 intervention

Trial outcomes

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

Time frame
first day after surgery, 3rd day, and 5th day

Secondary outcomes

1

wound healing assesment

clinical records, counting days for healing as healing by days till closure

Time frame
2 years
2

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

Time frame
first day after surgery to end of treatment at 3 months

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Faculty of Dentistry, Cairo University Status unavailable Manial, Cairo GovernorateEgyptEgypt

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cairo University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: