Cleft PalatePRGFNCT06889181
Role of Plasma Rich Growth Factor in Repair Primary Cleft Palate
A study testing Plasma Rich in Growth Factors (PRGF) in people with Cleft Palate and Plasma Rich in Growth Factors, run by Cairo University at 1 site in Egypt.
Trial summary
Does the plasma-rich growth factor (PRGF) with primary cleft palate repair accelerate wound healing and prevent post-operative oronasal fistula occurrence? Read more about this study
- Who is it for?
- Ages 6 to 18 monthsHealthy volunteers can take part
- Conditions the study is for
- Cleft Palate, Plasma Rich in Growth Factors
- What is being tested?
- Plasma Rich in Growth Factors (PRGF)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2025to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Faculty of Dentistry, Cairo University
Manial, Cairo Governorate
sarah horia, M.Sc., 00201010014043, sarahhoria@gmail.com
El noman MK El shafie, lecturer, 002001063999203, nomanmust@gmail.com
About this study
Official title: 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?
Read the 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
- Conditions
- Cleft Palate, Plasma Rich in Growth Factors
- Being tested
- Plasma Rich in Growth Factors (PRGF), Placebo
- Keywords
- cleft palate, plasma rich growth factor, healing
- Medical subject headings
- Cleft Palate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
PlaceboOther
primary closing cleft palate-isolated cleft palate
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: first day after surgery, 3rd day, and 5th day
Secondary outcomes (2)
wound healing assesment
clinical records, counting days for healing as healing by days till closure
Measured: 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
Measured: first day after surgery to end of treatment at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2025
- Study start1 Apr 2025 (estimated)
- Primary completion30 Jul 2025 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cleft PalateStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to either control or study group in the ratio of 1:1 using random number table.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Samir Horia, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06889181
- Sponsor's protocol ID
- Cleft palate - Omfs338
- Acronym
- PRGF
- Status last verified
- Mar 2025
- First submitted
- 7 Mar 2025
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06889181
- Acronym / sponsor ID
- PRGF / Cleft palate - Omfs338
- Conditions
- Cleft Palate, Plasma Rich in Growth Factors
- Keywords
- cleft palate, plasma rich growth factor, healing
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- 30 Jul 2025 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 21 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to either control or study group in the ratio of 1:1 using random number table.
| Arm | Type | Receives |
|---|---|---|
| plasma rich growth factor (PRGF) (intervention or study group) | Active comparator | Other: Plasma Rich in Growth Factors (PRGF)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 |
| placebo (control group) | Placebo comparator | Other: Placeboplacebo (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 |
Who may qualify
- Ages
- 6 to 18 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- Patients with recurrent palatal fistula
- Existence of syndromic cleft palate
- Blood diseases and platelet disorders (hematological disease)
- Systematic disease radiotherapy or chemotherapy for malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Other | plasma rich growth factor (PRGF) (intervention or study group) |
| Placeboprimary closing cleft palate-isolated cleft palate | Other | placebo (control group) |
Primary outcome
wound healing assesment (edema at 5th day post operatively)
Time frame: 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
2 secondary outcomes
wound healing assesment
Time frame: 2 years
the occurrence of oronasal fistula
Time frame: first day after surgery to end of treatment at 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plasma Rich in Growth Factors (PRGF) in people with Cleft Palate and Plasma Rich in Growth Factors, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
wound healing assesment (edema at 5th day post operatively) (time frame: first day after surgery, 3rd day, and 5th day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2025.