Cleft PalateNCT07752849
Palatoplasty Techniques Using PRF and Gentamicin-Loaded PRF in Cleft Palate
A study testing Platelet _ Rich Fibrin ( PRF) and gentamicin_ loaded PRF in people with Cleft Palate and Unilateral Cleft Palate, run by Al-Thawra Modern General Hospital at 1 site in Yemen.
Trial summary
This prospective, randomized controlled trial evaluates the clinical efficacy of autologous Platelet-Rich Fibrin (PRF) and Gentamicin-Loaded PRF as regenerative and antimicrobial biological adjuncts in primary palatoplasty. Read more about this study
- Who is it for?
- Ages 3 months to 18 years
- Conditions the study is for
- Cleft Palate, Unilateral Cleft Palate, Bilateral Cleft Palate
- What is being tested?
- Platelet _ Rich Fibrin ( PRF) and gentamicin_ loaded PRF
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteYemen
- Study dates
- 1 Aug 2026to Dec 2028
- 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 3 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients presenting with non-syndromic complete or incomplete unilateral or bilateral cleft palate.
- Scheduled for primary palatoplasty.
- Age within the specified study range.
- Informed consent signed by parents or legal guardians.
Who cannot join
- Patients with associated syndromic clefts or major congenital anomalies.
- Previous history of palatal surgery or failed prior palatoplasty.
- Bleeding disorders, active systemic infections, or contraindications to surgery or general anesthesia.
- Patients lost to follow-up or incomplete records.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Yemen1 site, 1 recruiting
- Recruiting
Al_ Thawra General Hospital Authority
Sanaa
SUMYAH Mohammed Abdulwasea, MSc Trainee, +967730129165, deman9038@gamil.com
About this study
Official title: A Prospective Randomized Clinical Trial Comparing Standard Palatoplasty Alone, Standard Palatoplasty With Platelet-Rich Fibrin (PRF), and Standard Palatoplasty With Gentamicin-Loaded PRF for Unilateral and Bilateral Complete and Incomplete Cleft Palate Cases
This prospective, randomized controlled trial evaluates the clinical efficacy of autologous Platelet-Rich Fibrin (PRF) and Gentamicin-Loaded PRF as regenerative and antimicrobial biological adjuncts in primary palatoplasty. A total of 90 pediatric and adolescent patients with unilateral and bilateral complete and incomplete cleft palates will be assigned across three parallel treatment arms: standard palatoplasty alone (control), palatoplasty augmented with standard PRF, and palatoplasty augmented with gentamicin-loaded PRF. The primary objective is to compare quantitative primary mucosal healing scores, wound dehiscence rates, and the incidence of postoperative oronasal fistula formation to determine whether local gentamicin-PRF delivery significantly improves soft-tissue healing and reduces surgical breakdown
- Conditions
- Cleft Palate, Unilateral Cleft Palate, Bilateral Cleft Palate, Complete Cleft Palat, Incompelet Cleft Palate
- Being tested
- Standard palatoplasty ( control), Platelet _ Rich Fibrin ( PRF), gentamicin_ loaded PRF
- Medical subject headings
- Cleft Palate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard palatoplasty ( control)Procedure or surgery
Conventional palatoplasty performed without biological adjuncts
Platelet _ Rich Fibrin ( PRF)Procedure or surgery
Conventional palatoplasty augmented with autologous PRF matrix
gentamicin_ loaded PRFCombination product
Conventional palatoplasty augmented with gentamicin _ loaded PRF matrix
| Study group | Role | What they receive |
|---|---|---|
| Standard palatoplasty ( control ) | Active comparator | Conventional palatoplasty without biological adjuncts Receives: Procedure: Standard palatoplasty ( control) |
| Standard palatoplasty + PRF | Experimental | Conventional palatoplasty augmented PRF Receives: Procedure: Platelet _ Rich Fibrin ( PRF) |
| Standard palatoplasty +Gentamicin- PRF | Experimental | Conventional palatoplasty augmented with gentamicine - loaded PRF Receives: Combination Product: gentamicin_ loaded PRF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound dehiscence rate
Assessed using Wound Dehiscence Severity Score (WDSS) ranging from 0 (Intact, complete structural integrity) to 3 (Complete failure, full-thickness structural separation requiring surgical revision). Higher scores indicate worse outcomes.
Measured: At 7 day , 14 day , and 30 day postoperatively
palatal fistula formation rate
Assessed using Oronasal Fistula Severity \& Dimension Score (OFSDS) ranging from 0 (Absent, intact palate) to 3 (Major fistula, anatomical defect > 5 mm requiring secondary surgical closure). Higher scores indicate worse outcomes
Measured: at 3 month postoperatively
wound healing score
Assessed using Modified Primary Healing Scale (MPHS) ranging from 1 (Optimal Healing) to 4 (Severe Failure). Higher scores indicate worse outcomes.
Measured: At 7 day , 14 day , and 30 day postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2026
- Study start1 Aug 2026
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (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.
- 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Thawra Modern General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sumyah Mohammed Abdulwasea Saeed, Al-Thawra Modern General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07752849
- Sponsor's protocol ID
- CLEFT_PRF_2026
- Status last verified
- Aug 2026
- First submitted
- 3 Aug 2026
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Clinical Trial Comparing Standard Palatoplasty Alone, Standard Palatoplasty With Platelet-Rich Fibrin (PRF), and Standard Palatoplasty With Gentamicin-Loaded PRF for Unilateral and Bilateral Complete and Incomplete Cleft Palate Cases
- ClinicalTrials.gov ID
- NCT07752849
- Acronym / sponsor ID
- CLEFT_PRF_2026
- Conditions
- Cleft Palate, Unilateral Cleft Palate, Bilateral Cleft Palate, Complete Cleft Palat, Incompelet Cleft Palate
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Al-Thawra Modern General HospitalUniversity, hospital or other
- Study start
- 1 Aug 2026 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 7 Aug 2026 (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.
This prospective, randomized controlled trial evaluates the clinical efficacy of autologous Platelet-Rich Fibrin (PRF) and Gentamicin-Loaded PRF as regenerative and antimicrobial biological adjuncts in primary palatoplasty. A total of 90 pediatric and adolescent patients with unilateral and bilateral complete and incomplete cleft palates will be assigned across three parallel treatment arms: standard palatoplasty alone (control), palatoplasty augmented with standard PRF, and palatoplasty augmented with gentamicin-loaded PRF. The primary objective is to compare quantitative primary mucosal healing scores, wound dehiscence rates, and the incidence of postoperative oronasal fistula formation to determine whether local gentamicin-PRF delivery significantly improves soft-tissue healing and reduces surgical breakdown
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard palatoplasty ( control ) | Active comparator | Procedure: Standard palatoplasty ( control)Conventional palatoplasty without biological adjuncts |
| Standard palatoplasty + PRF | Experimental | Procedure: Platelet _ Rich Fibrin ( PRF)Conventional palatoplasty augmented PRF |
| Standard palatoplasty +Gentamicin- PRF | Experimental | Combination Product: gentamicin_ loaded PRFConventional palatoplasty augmented with gentamicine - loaded PRF |
Who may qualify
- Ages
- 3 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Patients presenting with non-syndromic complete or incomplete unilateral or bilateral cleft palate.
- Scheduled for primary palatoplasty.
- Age within the specified study range.
- Informed consent signed by parents or legal guardians.
Key exclusion criteria (4 listed)
- Patients with associated syndromic clefts or major congenital anomalies.
- Previous history of palatal surgery or failed prior palatoplasty.
- Bleeding disorders, active systemic infections, or contraindications to surgery or general anesthesia.
- Patients lost to follow-up or incomplete records.
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 |
|---|---|---|
| Standard palatoplasty ( control)Conventional palatoplasty performed without biological adjuncts | Procedure or surgery | Standard palatoplasty ( control ) |
| Platelet _ Rich Fibrin ( PRF)Conventional palatoplasty augmented with autologous PRF matrix | Procedure or surgery | Standard palatoplasty + PRF |
| gentamicin_ loaded PRFConventional palatoplasty augmented with gentamicin _ loaded PRF matrix | Combination product | Standard palatoplasty +Gentamicin- PRF |
Primary outcome
Wound dehiscence rate
Time frame: At 7 day , 14 day , and 30 day postoperatively
Assessed using Wound Dehiscence Severity Score (WDSS) ranging from 0 (Intact, complete structural integrity) to 3 (Complete failure, full-thickness structural separation requiring surgical revision). Higher scores indicate worse outcomes.
palatal fistula formation rate
Time frame: at 3 month postoperatively
Assessed using Oronasal Fistula Severity \& Dimension Score (OFSDS) ranging from 0 (Absent, intact palate) to 3 (Major fistula, anatomical defect > 5 mm requiring secondary surgical closure). Higher scores indicate worse outcomes
wound healing score
Time frame: At 7 day , 14 day , and 30 day postoperatively
Assessed using Modified Primary Healing Scale (MPHS) ranging from 1 (Optimal Healing) to 4 (Severe Failure). Higher scores indicate worse outcomes.
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 7 Aug 2026.
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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 Platelet _ Rich Fibrin ( PRF) and gentamicin_ loaded PRF in people with Cleft Palate and Unilateral Cleft Palate, run by Al-Thawra Modern General Hospital at 1 site in Yemen.
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 4 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: looking for participants now, as of the sponsor's last update on 7 Aug 2026. 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 Yemen. 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. 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 dehiscence rate (time frame: At 7 day , 14 day , and 30 day postoperatively). The study lists 3 primary outcomes in all. 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 7 Aug 2026.