Mucogingival DefectsNCT06521333
Resveratrol-Based Gel Application in a Palatal Wound Following Free Gingival Graft Surgery
A study testing Resveratrol-Based gel, Hyaluronic acid gel 0.2% and Stent in people with Mucogingival Defects, run by Cairo University at 1 site in Egypt.
Trial summary
Aim of the study to compare the effect of Resveratrol- Based gel versus 0.2% Hyaluronic acid gel applied to the palatal donor site and acrylic resin stent only in post-operative pain reduction after free gingival graft harvesting. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mucogingival Defects
- What is being tested?
- Resveratrol-Based gel, Hyaluronic acid gel 0.2% and Stent
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 14 May 2024to 1 Jan 2026
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient over 18 years of age
- Systemically healthy
- Plaque index (PI) and gingival index (GI) less than 15% (Silness \& Löe)
- Patients with Mucogingival defects scheduled for free gingival graft
Who cannot join
- Pregnancy or breastfeeding.
- Occlusal trauma at site of graft.
- Severe gagging reflex
- Smokers.
- Patients allergic to the used materials.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Resveratrol-Based Gel Versus Hyaluronic Acid Gel as a Palatal Wound Dressing Materials on Postoperative Pain Following Free Gingival Graft Surgery: A Randomized Controlled Clinical Trial
Aim of the study to compare the effect of Resveratrol- Based gel versus 0.2% Hyaluronic acid gel applied to the palatal donor site and acrylic resin stent only in post-operative pain reduction after free gingival graft harvesting.
Read the detailed description
Treatment Protocol Presurgical Phase Initial phase will involve comprehensive periodontal treatment, including full mouth supragingival scaling, subgingival debridement using ultrasonic devices and Gracey curettes, and polishing one month prior to surgery. Patients will receive detailed instructions on mechanical plaque control techniques, such as the brushing technique with a soft toothbrush, and the importance of maintaining oral health.
Additionally, 0.12% Chlorhexidine HCL mouthwash will be prescribed for chemical plaque control, to be used twice daily for 2 weeks.
Surgical procedure Step 1: Preparing the recipient site. Step 2: Harvesting the free gingival graft from palate. The Free Gingival Graft (FGG) will be harvested from the palate using a standardized technique. The palatal sites will be anaesthetized with a solution of 2% lidocaine and 0.001% adrenaline. A partial thickness graft, consisting of epithelium and a thin layer of connective tissue, will be harvested with proper thickness between 1.0 and 1.5 mm for optimal graft survival.
Step 3: Placement of free gingival graft on the recipient beds Step 4: Management of the Palatal Wound
Denuded palatal area will be protected using one of the following options:
- Resveratrol- Based gel covered with acrylic resin stent (test group I).
- Hyaluronic acid (HA) gel 0.2% with acrylic resin stent (test group II)
- Acrylic resin stent (control group III) Test Group I Resveratrol- Based gel The Resveratrol-Based gel will be applied using a sterile plastic syringe, and the palatal wound will be immediately covered by an acrylic resin stent. Three days postoperatively, the patients will be recalled, the stent will be removed for evaluation and the Resveratrol gel will be reapplied. Test Group II (0.2% HA) 0.2% hyaluronic acid gel (Gengigel®) The 0.2% Hyaluronic acid gel will be applied using a sterile plastic syringe, and the palatal wound will be covered by an acrylic resin stent. Three days postoperatively, the patients will be recalled, the stent will be removed for evaluation, and the Hyaluronic acid gel will be reapplied.
Group III (Control Group) The palatal wound will be immediately covered by acrylic resin stent three days postoperatively, the patients will be recalled, and the stent will be removed for evaluating the healing of the palatal wound and then recover with stent.
Step 5: Postoperative care The postoperative instructions will be specified to avoid using a toothbrush or floss in the vicinity of the surgical sites. During the first week, patients will be instructed to limit their food intake to soft foods and to avoid any mechanical trauma.
Patient evaluation of post-operative morbidity and aesthetics will be conducted during appointments on days 3, 7, 14, 21, and 42 following the evaluation.
- Conditions
- Mucogingival Defects
- Being tested
- Resveratrol-Based gel, Hyaluronic acid gel 0.2%, Stent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resveratrol-Based gelDrug
The Resveratrol-Based gel will be applied using a sterile plastic syringe, and the palatal wound will be immediately covered by an acrylic resin stent. Three days postoperatively, the patients will be recalled, the stent will be removed for evaluation and the Resveratrol gel will be reapplied.
Hyaluronic acid gel 0.2%Drug
Also called Gengigel
The 0.2% Hyaluronic acid gel will be applied using a sterile plastic syringe, and the palatal wound will be covered by an acrylic resin stent. Three days postoperatively, the patients will be recalled, the stent will be removed for evaluation, and the Hyaluronic acid gel will be reapplied.
StentDevice
The palatal wound will be immediately covered by acrylic resin stent three days postoperatively, the patients will be recalled, and the stent will be removed for evaluating the healing of the palatal wound and then recover with stent.
| Study group | Role | What they receive |
|---|---|---|
| Resveratrol-Based gel | Experimental | The Resveratrol-Based gel will be applied using a sterile plastic syringe, and the palatal wound will be immediately covered by an acrylic resin stent. Three days postoperatively, the patients will be recalled, the stent will be removed for evaluation and the Resveratrol gel will be reapplied. Receives: Drug: Resveratrol-Based gel |
| Hyaluronic acid gel 0.2% | Active comparator | 0.2% hyaluronic acid gel (Gengigel®) The 0.2% Hyaluronic acid gel will be applied using a sterile plastic syringe, and the palatal wound will be covered by an acrylic resin stent. Three days postoperatively, the patients will be recalled, the stent will be removed for evaluation, and the Hyaluronic acid gel will be reapplied. Receives: Drug: Hyaluronic acid gel 0.2% |
| Acrylic resin stent only. | Placebo comparator | The palatal donor site covered with acrylic resin stent only. Receives: Device: Stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain
direct measure by using Visual Analog Scale (VAS) pain scores (ranging from 0 to 10, where 0 indicates no pain 1: minimal pain and 10 signifies severe pain) will be recorded daily for one week as the pain is expected to reach its maximum level during the initial healing phase (0-3 days)
Measured: at (0--7 days)
Secondary outcomes (4)
Indirect Postoperative Pain by analgesic consumption consumption Postoperative
Pain Indirect measurement by analgesic consumption Postoperative for 7 days postoperatively
Measured: at (0-7) days
Wound size
measure by using UNC-15 periodontal probe.
Measured: at surgery day, day 3, day 7, day 14 and day 21
patient satisfaction with the healing process
measure by using Visual analogue scale.
a Visual Analog Scale (VAS) specifically designed for measuring patient satisfaction with medical care. This type of scale allows patients to express their level of satisfaction by marking a point along a continuous line, which is typically 10 cm long, representing a range from complete dissatisfaction (0) to full satisfaction (10).
Measured: completed 1 week after the surgery
Color match..
measure by using Visual analogue scale. Colour match (CM) of the donor site was also assessment by using VAS scores (between 0 and 10. 0: no CM, 10: excellent CM) in comparison with adjacent and contra-lateral palatal mucosa.
Measured: on day 3, day 7, day 14, day 21, and day 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2024
- Study start14 May 2024
- Primary completion30 Dec 2025
- Study completion1 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mucogingival DefectsStudies 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
- A Randomized Controlled Clinical Trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liza saleh kasem ALhakam, Cairo University
- Investigators
- Liza S ALhakam, Principal investigator, master student.Manar T El-Zanaty, PhD, Study chair, Lecturer of oral medicine and Periodontology, Faculty of Dentistry, Cairo University.Enji A Mahmoud, Professor, Study director, Professor of Oral Medicine and Periodontology, Faculty of Dentistry, Cairo University.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06521333
- Sponsor's protocol ID
- 19424
- Status last verified
- Jul 2024
- First submitted
- 21 Jul 2024
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Resveratrol-Based Gel Versus Hyaluronic Acid Gel as a Palatal Wound Dressing Materials on Postoperative Pain Following Free Gingival Graft Surgery: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06521333
- Acronym / sponsor ID
- 19424
- Conditions
- Mucogingival Defects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 14 May 2024 (actual)
- Primary completion
- 30 Dec 2025 (actual)
- Study completion
- 1 Jan 2026 (actual)
- First posted
- 25 Jul 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.
Aim of the study to compare the effect of Resveratrol- Based gel versus 0.2% Hyaluronic acid gel applied to the palatal donor site and acrylic resin stent only in post-operative pain reduction after free gingival graft harvesting.
Detailed description
Treatment Protocol Presurgical Phase Initial phase will involve comprehensive periodontal treatment, including full mouth supragingival scaling, subgingival debridement using ultrasonic devices and Gracey curettes, and polishing one month prior to surgery. Patients will receive detailed instructions on mechanical plaque control techniques, such as the brushing technique with a soft toothbrush, and the importance of maintaining oral health.
Additionally, 0.12% Chlorhexidine HCL mouthwash will be prescribed for chemical plaque control, to be used twice daily for 2 weeks.
Surgical procedure Step 1: Preparing the recipient site. Step 2: Harvesting the free gingival graft from palate. The Free Gingival Graft (FGG) will be harvested from the palate using a standardized technique. The palatal sites will be anaesthetized with a solution of 2% lidocaine and 0.001% adrenaline. A partial thickness graft, consisting of epithelium and a thin layer of connective tissue, will be harvested with proper thickness between 1.0 and 1.5 mm for optimal graft survival.
Step 3: Placement of free gingival graft on the recipient beds Step 4: Management of the Palatal Wound
Denuded palatal area will be protected using one of the following options:
- Resveratrol- Based gel covered with acrylic resin stent (test group I).
- Hyaluronic acid (HA) gel 0.2% with acrylic resin stent (test group II)
- Acrylic resin stent (control group III) Test Group I Resveratrol- Based gel The Resveratrol-Based gel will be applied using a sterile plastic syringe, and the palatal wound will be immediately covered by an acrylic resin stent. Three days postoperatively, the patients will be recalled, the stent will be removed for evaluation and the Resveratrol gel will be reapplied. Test Group II (0.2% HA) 0.2% hyaluronic acid gel (Gengigel®) The 0.2% Hyaluronic acid gel will be applied using a sterile plastic syringe, and the palatal wound will be covered by an acrylic resin stent. Three days postoperatively, the patients will be recalled, the stent will be removed for evaluation, and the Hyaluronic acid gel will be reapplied.
Group III (Control Group) The palatal wound will be immediately covered by acrylic resin stent three days postoperatively, the patients will be recalled, and the stent will be removed for evaluating the healing of the palatal wound and then recover with stent.
Step 5: Postoperative care The postoperative instructions will be specified to avoid using a toothbrush or floss in the vicinity of the surgical sites. During the first week, patients will be instructed to limit their food intake to soft foods and to avoid any mechanical trauma.
Patient evaluation of post-operative morbidity and aesthetics will be conducted during appointments on days 3, 7, 14, 21, and 42 following the evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
- Model description
- A Randomized Controlled Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| Resveratrol-Based gel | Experimental | Drug: Resveratrol-Based gelThe Resveratrol-Based gel will be applied using a sterile plastic syringe, and the palatal wound will be immediately covered by an acrylic resin stent. Three days postoperatively, the patients will be recalled, the stent will be removed for evaluation and the Resveratrol gel will be reapplied. |
| Hyaluronic acid gel 0.2% | Active comparator | Drug: Hyaluronic acid gel 0.2%0.2% hyaluronic acid gel (Gengigel®) The 0.2% Hyaluronic acid gel will be applied using a sterile plastic syringe, and the palatal wound will be covered by an acrylic resin stent. Three days postoperatively, the patients will be recalled, the stent will be removed for evaluation, and the Hyaluronic acid gel will be reapplied. |
| Acrylic resin stent only. | Placebo comparator | Device: StentThe palatal donor site covered with acrylic resin stent only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient over 18 years of age
- Systemically healthy
- Plaque index (PI) and gingival index (GI) less than 15% (Silness \& Löe)
- Patients with Mucogingival defects scheduled for free gingival graft
Key exclusion criteria (5 listed)
- Pregnancy or breastfeeding.
- Occlusal trauma at site of graft.
- Severe gagging reflex
- Smokers.
- Patients allergic to the used materials.
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 |
|---|---|---|
| Resveratrol-Based gelThe Resveratrol-Based gel will be applied using a sterile plastic syringe, and the palatal wound will be immediately covered by an acrylic resin stent. Three days postoperatively, the patients will be recalled, the stent will be removed for evaluation and the Resveratrol gel will be reapplied. | Drug | Resveratrol-Based gel |
| Hyaluronic acid gel 0.2%Also: GengigelThe 0.2% Hyaluronic acid gel will be applied using a sterile plastic syringe, and the palatal wound will be covered by an acrylic resin stent. Three days postoperatively, the patients will be recalled, the stent will be removed for evaluation, and the Hyaluronic acid gel will be reapplied. | Drug | Hyaluronic acid gel 0.2% |
| StentThe palatal wound will be immediately covered by acrylic resin stent three days postoperatively, the patients will be recalled, and the stent will be removed for evaluating the healing of the palatal wound and then recover with stent. | Device | Acrylic resin stent only. |
Primary outcome
Postoperative Pain
Time frame: at (0--7 days)
direct measure by using Visual Analog Scale (VAS) pain scores (ranging from 0 to 10, where 0 indicates no pain 1: minimal pain and 10 signifies severe pain) will be recorded daily for one week as the pain is expected to reach its maximum level during the initial healing phase (0-3 days)
4 secondary outcomes
Indirect Postoperative Pain by analgesic consumption consumption Postoperative
Time frame: at (0-7) days
Wound size
Time frame: at surgery day, day 3, day 7, day 14 and day 21
patient satisfaction with the healing process
Time frame: completed 1 week after the surgery
Color match..
Time frame: on day 3, day 7, day 14, day 21, and day 42
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 17 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Mucogingival Defects, Recession, Gingival
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.
Liza S ALhakam principal investigator
master student.
Manar T El-Zanaty, PhD study chair
Lecturer of oral medicine and Periodontology, Faculty of Dentistry, Cairo University.
Enji A Mahmoud, Professor study director
Professor of Oral Medicine and Periodontology, Faculty of Dentistry, Cairo University.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resveratrol-Based gel, Hyaluronic acid gel 0.2% and Stent in people with Mucogingival Defects, 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 4 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 17 Mar 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 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?
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?
Postoperative Pain (time frame: at (0--7 days)). 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 17 Mar 2026.