Palatal WoundNCT06610331
EVALUATION OF THE EFFECT OF POLYVINYLPYROLIDONE AND SODIUM HYALURONATE GEL ON PALATINAL WOUND HEALING
A study testing FREE GİNGİVAL GRAFT and polyvinylpyrrolidone sodium hyaluronate gel in people with Palatal Wound, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this clinical study was to evaluate the effect of polyvinylpyrrolidone sodium hyaluronate gel on palatal wound healing, pain, and bleeding after free gingival graft surgery. This study included 32 systemically healthy patients who required free gingival graft surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Palatal Wound
- What is being tested?
- FREE GİNGİVAL GRAFT and polyvinylpyrrolidone sodium hyaluronate gel
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2024to 15 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Able to adapt to the study, not having a physical or psychological condition that would prevent surgical procedure under local anesthesia, and being able to follow the planned operation and control sessions
- Patients who consciously accept and sign the detailed informed consent form regarding the study that will be explained to them verbally
- Insufficiently attached gingiva on the mandibular or maxillary vestibular teeth and implant surfaces
Who cannot join
- Presence of infection and inflammation in the recipient and donor area
- Presence of systemic disease
- Women who are pregnant, suspected of being pregnant or breastfeeding
- Smoking
- Orofacial neurological symptoms
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bolu Abant Izzet Baysal University Faculty of Dentistry Department of Periodontology
Bolu, 14000
About this study
Official title: EVALUATION OF THE EFFECT OF POLYVINYLPYROLIDONE AND SODIUM HYALURONATE GEL ON PALATINAL WOUND HEALING: A RANDOMIZED CONTROLLED CLINICAL STUDY
The aim of this clinical study was to evaluate the effect of polyvinylpyrrolidone sodium hyaluronate gel on palatal wound healing, pain, and bleeding after free gingival graft surgery. This study included 32 systemically healthy patients who required free gingival graft surgery. After the operation, the test group received polyvinylpyrrolidone sodium hyaluronate gel in addition to chlorhexidine gluconate mouthwash, whereas the control group received only chlorhexidine gluconate mouthwash. VAS scale was used to evaluate palatal pain, burning, and chewing discomfort, WHI was used to evaluate wound healing, and H2O2 foaming test was used to evaluate epithelialization. VAS and bleeding values were recorded on postoperative day 1; VAS, WHI, H2O2, and bleeding values on postoperative days 3, 7, and 14; and WHI, H2O2, and bleeding values on postoperative day 28.
- Conditions
- Palatal Wound
- Being tested
- FREE GİNGİVAL GRAFT, polyvinylpyrrolidone sodium hyaluronate gel
- Keywords
- WOUND HEALİNG, sodium hyaluronate, Polyvinylpyrrolidone, Free gingival graft, PALATAL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FREE GİNGİVAL GRAFTProcedure or surgery
Free Gingival Graft removal from the palate donor area for the treatment of gingival recession
polyvinylpyrrolidone sodium hyaluronate gelDevice
Patients are told to gargle with a mouthwash containing polyvinyl pyrrolidone sodium hyaluronate twice a day for 2 weeks. 15 ml (1 tablespoon) of mouthwash containing polyvinyl pyrrolidone sodium hyaluronate is poured into a glass and approximately 40 ml (3 tablespoons) of water is added and mixed well, then it is shaken for at least 1 minute, making contact with the entire mouth.
| Study group | Role | What they receive |
|---|---|---|
| Control Group - Free Gingival Graft | Sham comparator | Not described Receives: Procedure: FREE GİNGİVAL GRAFT |
| Test Group - Free Gingival Graft + polyvinylpyrrolidone sodium hyaluronate gel | Experimental | Not described Receives: Procedure: FREE GİNGİVAL GRAFT; Device: polyvinylpyrrolidone sodium hyaluronate gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Epithelialization
Epithelialization of the palatal region was performed by applying 3% hydrogen peroxide to the wound area with the help of an injector, and the areas showing foaming (H2O2 bubbling) in the total surface area of the wound area were calculated as a percentage and recorded, providing information about epithelialization.
Measured: 28 days
Secondary outcomes (1)
wound healing
Palatal wound healing was assessed using the Wound Healing Index (WHI) as described by Landry et al. (1985)
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2024
- Study start1 Feb 2024
- Primary completion10 Jul 2024
- Study completion15 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Palatal WoundStudies of the same condition, open and under way.
- More trials run by Abant Izzet Baysal 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, nuray Ercan, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06610331
- Sponsor's protocol ID
- BAIBU-SBF-NE-01
- Status last verified
- Sep 2024
- First submitted
- 20 Sep 2024
- Last updated
- 24 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Bulut T, Ercan N. The effect of Polyvinylpyrrolidone-Sodium hyaluronate gel on palatal wound healing: a randomized controlled clinical trial. BMC Oral Health. 2025 Aug 8;25(1):1305. doi: 10.1186/s12903-025-06677-w.
PubMed 40781616
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EVALUATION OF THE EFFECT OF POLYVINYLPYROLIDONE AND SODIUM HYALURONATE GEL ON PALATINAL WOUND HEALING: A RANDOMIZED CONTROLLED CLINICAL STUDY
- ClinicalTrials.gov ID
- NCT06610331
- Acronym / sponsor ID
- BAIBU-SBF-NE-01
- Conditions
- Palatal Wound
- Keywords
- WOUND HEALİNG, sodium hyaluronate, Polyvinylpyrrolidone, Free gingival graft, PALATAL
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 10 Jul 2024 (actual)
- Study completion
- 15 Aug 2024 (actual)
- First posted
- 24 Sep 2024 (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.
The aim of this clinical study was to evaluate the effect of polyvinylpyrrolidone sodium hyaluronate gel on palatal wound healing, pain, and bleeding after free gingival graft surgery. This study included 32 systemically healthy patients who required free gingival graft surgery. After the operation, the test group received polyvinylpyrrolidone sodium hyaluronate gel in addition to chlorhexidine gluconate mouthwash, whereas the control group received only chlorhexidine gluconate mouthwash. VAS scale was used to evaluate palatal pain, burning, and chewing discomfort, WHI was used to evaluate wound healing, and H2O2 foaming test was used to evaluate epithelialization. VAS and bleeding values were recorded on postoperative day 1; VAS, WHI, H2O2, and bleeding values on postoperative days 3, 7, and 14; and WHI, H2O2, and bleeding values on postoperative day 28.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group - Free Gingival Graft | Sham comparator | Procedure: FREE GİNGİVAL GRAFT |
| Test Group - Free Gingival Graft + polyvinylpyrrolidone sodium hyaluronate gel | Experimental | Procedure: FREE GİNGİVAL GRAFT, Device: polyvinylpyrrolidone sodium hyaluronate gel |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Able to adapt to the study, not having a physical or psychological condition that would prevent surgical procedure under local anesthesia, and being able to follow the planned operation and control sessions
- Patients who consciously accept and sign the detailed informed consent form regarding the study that will be explained to them verbally
- Insufficiently attached gingiva on the mandibular or maxillary vestibular teeth and implant surfaces
Key exclusion criteria (5 listed)
- Presence of infection and inflammation in the recipient and donor area
- Presence of systemic disease
- Women who are pregnant, suspected of being pregnant or breastfeeding
- Smoking
- Orofacial neurological symptoms
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 |
|---|---|---|
| FREE GİNGİVAL GRAFTFree Gingival Graft removal from the palate donor area for the treatment of gingival recession | Procedure or surgery | Control Group - Free Gingival Graft, Test Group - Free Gingival Graft + polyvinylpyrrolidone sodium hyaluronate gel |
| polyvinylpyrrolidone sodium hyaluronate gelPatients are told to gargle with a mouthwash containing polyvinyl pyrrolidone sodium hyaluronate twice a day for 2 weeks. 15 ml (1 tablespoon) of mouthwash containing polyvinyl pyrrolidone sodium hyaluronate is poured into a glass and approximately 40 ml (3 tablespoons) of water is added and mixed well, then it is shaken for at least 1 minute, making contact with the entire mouth. | Device | Test Group - Free Gingival Graft + polyvinylpyrrolidone sodium hyaluronate gel |
Primary outcome
Epithelialization
Time frame: 28 days
Epithelialization of the palatal region was performed by applying 3% hydrogen peroxide to the wound area with the help of an injector, and the areas showing foaming (H2O2 bubbling) in the total surface area of the wound area were calculated as a percentage and recorded, providing information about epithelialization.
1 secondary outcome
wound healing
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2024.
- Derived from this study: PubMed 40781616Bulut T, Ercan N. The effect of Polyvinylpyrrolidone-Sodium hyaluronate gel on palatal wound healing: a randomized controlled clinical trial. BMC Oral Health. 2025 Aug 8;25(1):1305. doi: 10.1186/s12903-025-06677-w.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FREE GİNGİVAL GRAFT and polyvinylpyrrolidone sodium hyaluronate gel in people with Palatal Wound, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
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 5 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: finished, as of the sponsor's last update on 24 Sep 2024. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Epithelialization (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06610331, which also lists 1 linked publication.
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 24 Sep 2024.