Palatal Donor Site Wound HealingNCT07689695
MOUTHRİNSES AND PALATAL DONOR SİTE HEALİNG AFTER FREE GİNGİVAL GRAFT
A study testing Hypochlorous Acid, Hyaluronic Acid (HA) and Chlorhexidine gluconate 0.2% in people with Palatal Donor Site Wound Healing and Periodontal Plastic Surgery, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
Trial summary
This single-blind randomized controlled clinical trial aimed to compare the effects of hypochlorous acid, hyaluronic acid, and chlorhexidine mouthrinses on palatal donor site healing following free gingival graft surgery. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Palatal Donor Site Wound Healing, Periodontal Plastic Surgery
- What is being tested?
- Hypochlorous Acid, Hyaluronic Acid (HA) and Chlorhexidine gluconate 0.2%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jun 2020to 7 Jul 2021
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 18 and 55 years.
- Indication for free gingival graft surgery to increase keratinized tissue width.
- Systemically healthy individuals.
- Palatal donor site suitable for graft harvesting.
- No history of periodontal surgery within the previous six months.
- Ability and willingness to comply with postoperative instructions and follow-up visits.
- Provision of written informed consent.
Who cannot join
- Systemic diseases that could affect wound healing.
- Smoking.
- Antibiotic use within the previous six months.
- Pregnancy or lactation.
- Known hypersensitivity to chlorhexidine, hypochlorous acid, hyaluronic acid, or any component of the study products.
- Active oral infection, periodontal abscess, or poor oral hygiene.
- Previous palatal surgery, mucosal lesions, anatomical limitations, or conditions affecting hemostasis at the donor site.
- Inability or unwillingness to comply with the study protocol.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Van Yuzuncu Yil University Faculty of Dentistry
Van, Tuşba, 65100
About this study
Official title: COMPARİSON OF HYPOCHLOROUS ACİD, HYALURONİC ACİD, AND CHLORHEXİDİNE MOUTHRİNSES ON PALATAL DONOR SİTE HEALİNG FOLLOWİNG FREE GİNGİVAL GRAFT SURGERY: A SİNGLE-BLİND CONTROLLED CLİNİCAL TRİAL
This single-blind randomized controlled clinical trial aimed to compare the effects of hypochlorous acid, hyaluronic acid, and chlorhexidine mouthrinses on palatal donor site healing following free gingival graft surgery. Fifty-four patients requiring free gingival graft surgery were randomly assigned to one of three mouthrinse groups. Clinical wound healing, wound dimensions, epithelialization, tissue consistency, bleeding control, and postoperative pain were evaluated during a 28-day follow-up period. The findings of this study may contribute to the identification of an effective postoperative mouthrinse for improving palatal donor site healing and patient comfort.
Read the detailed description
Free gingival graft (FGG) surgery is a well-established periodontal procedure for increasing the width of keratinized tissue. Healing of the palatal donor site is often associated with postoperative pain and patient discomfort. Various mouthrinses have been proposed to improve wound healing and reduce postoperative symptoms; however, evidence comparing hypochlorous acid, hyaluronic acid, and chlorhexidine is limited.
This single-blind, parallel-group, randomized controlled clinical trial was conducted to compare the effects of hypochlorous acid, hyaluronic acid, and chlorhexidine mouthrinses on palatal donor site healing following FGG surgery. Fifty-four participants requiring FGG surgery were randomly allocated to one of three intervention groups. Clinical assessments included wound dimensions, wound healing index, epithelialization, tissue consistency, bleeding control, and postoperative pain using a visual analogue scale. Participants were followed for 28 days after surgery. The primary objective was to evaluate the effect of each mouthrinse on palatal donor site healing and postoperative recovery.
- Being tested
- Hypochlorous Acid, Hyaluronic Acid (HA), Chlorhexidine gluconate 0.2%
- Keywords
- Free gingival graft, Hypochlorous acid, Hyaluronic acid, Chlorhexidine, Palatal wound healing, Soft tissue healing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypochlorous AcidDrug
Commercially available hypochlorous acid mouthrinse (Crystalin®, NHP İlaç San. ve Tic. A.Ş., Ankara, Türkiye). Participants rinsed with 15 mL for 60 seconds three times daily for 14 days beginning 24 hours after free gingival graft surgery.
Hyaluronic Acid (HA)Drug
Commercially available hyaluronic acid mouthrinse (Gengigel®, Ricerfarma, Milan, Italy). Participants rinsed with 15 mL for 60 seconds three times daily for 14 days beginning 24 hours after free gingival graft surgery.
Chlorhexidine gluconate 0.2%Drug
Commercially available 0.2% chlorhexidine gluconate mouthrinse (Kloroben®, Drogsan, Ankara, Türkiye). Participants rinsed with 15 mL for 60 seconds three times daily for 14 days beginning 24 hours after free gingival graft surgery.
| Study group | Role | What they receive |
|---|---|---|
| Hypochlorous Acid Mouthrinse | Experimental | Participants received a commercially available hypochlorous acid mouthrinse (Crystalin®, NHP İlaç San. ve Tic. A.Ş., Ankara, Türkiye). Participants were instructed to rinse with 15 mL for 60 seconds, three times daily for 14 days, beginning 24 hours after free gingival graft surgery. Receives: Drug: Hypochlorous Acid |
| Hyaluronic Acid Mouthrinse | Experimental | Participants received a commercially available hyaluronic acid mouthrinse (Gengigel®, Ricerfarma, Milan, Italy). Participants were instructed to rinse with 15 mL for 60 seconds, three times daily for 14 days, beginning 24 hours after free gingival graft surgery. Receives: Drug: Hyaluronic Acid (HA) |
| 0.2% Chlorhexidine Mouthrinse | Active comparator | Participants received a commercially available 0.2% chlorhexidine gluconate mouthrinse (Kloroben®, Drogsan, Ankara, Türkiye). Participants were instructed to rinse with 15 mL for 60 seconds, three times daily for 14 days, beginning 24 hours after free gingival graft surgery. Receives: Drug: Chlorhexidine gluconate 0.2% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Palatal donor site wound healing assessed using the Wound Healing Index (WHI)
Wound healing was evaluated using the Wound Healing Index (WHI) following free gingival graft surgery. The index was used to compare the healing effects of hypochlorous acid, hyaluronic acid, and chlorhexidine mouthrinses.
Measured: 28 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2026
- Study start20 Jun 2020
- Primary completion7 Jul 2021
- Study completion7 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Palatal Donor Site Wound HealingStudies 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
- Model description
- Participants were randomly assigned to one of three parallel groups receiving hypochlorous acid, hyaluronic acid, or 0.2% chlorhexidine mouthrinse following free gingival graft surgery.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kübra Eskin, Yuzuncu Yil University
- Investigators
- Hacer Şahin Aydınyurt, DDS, PhD, Principal investigator, Van Yuzuncu Yil University Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07689695
- Sponsor's protocol ID
- FGG-RCT-2021-01
- Status last verified
- Jul 2026
- First submitted
- 1 Jul 2026
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared because participant consent for public data sharing was not obtained at the time of enrollment, and the dataset contains information that could potentially compromise participant confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMPARİSON OF HYPOCHLOROUS ACİD, HYALURONİC ACİD, AND CHLORHEXİDİNE MOUTHRİNSES ON PALATAL DONOR SİTE HEALİNG FOLLOWİNG FREE GİNGİVAL GRAFT SURGERY: A SİNGLE-BLİND CONTROLLED CLİNİCAL TRİAL
- ClinicalTrials.gov ID
- NCT07689695
- Acronym / sponsor ID
- FGG-RCT-2021-01
- Keywords
- Free gingival graft, Hypochlorous acid, Hyaluronic acid, Chlorhexidine, Palatal wound healing, Soft tissue healing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- 20 Jun 2020 (actual)
- Primary completion
- 7 Jul 2021 (actual)
- Study completion
- 7 Jul 2021 (actual)
- First posted
- 8 Jul 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 single-blind randomized controlled clinical trial aimed to compare the effects of hypochlorous acid, hyaluronic acid, and chlorhexidine mouthrinses on palatal donor site healing following free gingival graft surgery. Fifty-four patients requiring free gingival graft surgery were randomly assigned to one of three mouthrinse groups. Clinical wound healing, wound dimensions, epithelialization, tissue consistency, bleeding control, and postoperative pain were evaluated during a 28-day follow-up period. The findings of this study may contribute to the identification of an effective postoperative mouthrinse for improving palatal donor site healing and patient comfort.
Detailed description
Free gingival graft (FGG) surgery is a well-established periodontal procedure for increasing the width of keratinized tissue. Healing of the palatal donor site is often associated with postoperative pain and patient discomfort. Various mouthrinses have been proposed to improve wound healing and reduce postoperative symptoms; however, evidence comparing hypochlorous acid, hyaluronic acid, and chlorhexidine is limited.
This single-blind, parallel-group, randomized controlled clinical trial was conducted to compare the effects of hypochlorous acid, hyaluronic acid, and chlorhexidine mouthrinses on palatal donor site healing following FGG surgery. Fifty-four participants requiring FGG surgery were randomly allocated to one of three intervention groups. Clinical assessments included wound dimensions, wound healing index, epithelialization, tissue consistency, bleeding control, and postoperative pain using a visual analogue scale. Participants were followed for 28 days after surgery. The primary objective was to evaluate the effect of each mouthrinse on palatal donor site healing and postoperative recovery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Participants were randomly assigned to one of three parallel groups receiving hypochlorous acid, hyaluronic acid, or 0.2% chlorhexidine mouthrinse following free gingival graft surgery.
| Arm | Type | Receives |
|---|---|---|
| Hypochlorous Acid Mouthrinse | Experimental | Drug: Hypochlorous AcidParticipants received a commercially available hypochlorous acid mouthrinse (Crystalin®, NHP İlaç San. ve Tic. A.Ş., Ankara, Türkiye). Participants were instructed to rinse with 15 mL for 60 seconds, three times daily for 14 days, beginning 24 hours after free gingival graft surgery. |
| Hyaluronic Acid Mouthrinse | Experimental | Drug: Hyaluronic Acid (HA)Participants received a commercially available hyaluronic acid mouthrinse (Gengigel®, Ricerfarma, Milan, Italy). Participants were instructed to rinse with 15 mL for 60 seconds, three times daily for 14 days, beginning 24 hours after free gingival graft surgery. |
| 0.2% Chlorhexidine Mouthrinse | Active comparator | Drug: Chlorhexidine gluconate 0.2%Participants received a commercially available 0.2% chlorhexidine gluconate mouthrinse (Kloroben®, Drogsan, Ankara, Türkiye). Participants were instructed to rinse with 15 mL for 60 seconds, three times daily for 14 days, beginning 24 hours after free gingival graft surgery. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age between 18 and 55 years.
- Indication for free gingival graft surgery to increase keratinized tissue width.
- Systemically healthy individuals.
- Palatal donor site suitable for graft harvesting.
- No history of periodontal surgery within the previous six months.
Key exclusion criteria (8 listed)
- Systemic diseases that could affect wound healing.
- Smoking.
- Antibiotic use within the previous six months.
- Pregnancy or lactation.
- Known hypersensitivity to chlorhexidine, hypochlorous acid, hyaluronic acid, or any component of the study products.
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 |
|---|---|---|
| Hypochlorous AcidCommercially available hypochlorous acid mouthrinse (Crystalin®, NHP İlaç San. ve Tic. A.Ş., Ankara, Türkiye). Participants rinsed with 15 mL for 60 seconds three times daily for 14 days beginning 24 hours after free gingival graft surgery. | Drug | Hypochlorous Acid Mouthrinse |
| Hyaluronic Acid (HA)Commercially available hyaluronic acid mouthrinse (Gengigel®, Ricerfarma, Milan, Italy). Participants rinsed with 15 mL for 60 seconds three times daily for 14 days beginning 24 hours after free gingival graft surgery. | Drug | Hyaluronic Acid Mouthrinse |
| Chlorhexidine gluconate 0.2%Commercially available 0.2% chlorhexidine gluconate mouthrinse (Kloroben®, Drogsan, Ankara, Türkiye). Participants rinsed with 15 mL for 60 seconds three times daily for 14 days beginning 24 hours after free gingival graft surgery. | Drug | 0.2% Chlorhexidine Mouthrinse |
Primary outcome
Palatal donor site wound healing assessed using the Wound Healing Index (WHI)
Time frame: 28 days after surgery
Wound healing was evaluated using the Wound Healing Index (WHI) following free gingival graft surgery. The index was used to compare the healing effects of hypochlorous acid, hyaluronic acid, and chlorhexidine mouthrinses.
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 8 Jul 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared because participant consent for public data sharing was not obtained at the time of enrollment, and the dataset contains information that could potentially compromise participant confidentiality.
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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.
Hacer Şahin Aydınyurt, DDS, PhD principal investigator
Van Yuzuncu Yil University Faculty of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypochlorous Acid, Hyaluronic Acid (HA) and Chlorhexidine gluconate 0.2% in people with Palatal Donor Site Wound Healing and Periodontal Plastic Surgery, run by Yuzuncu Yil 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 7 inclusion and 8 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 8 Jul 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 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. 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?
Palatal donor site wound healing assessed using the Wound Healing Index (WHI) (time frame: 28 days after surgery). 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 8 Jul 2026.