Palatal WoundNCT06806566
Assessment of a Carvacrol-loaded Absorbable Gelatin Sponge Used as a Palatal Dressing Following Free Gingival Graft Harvesting.
A study testing Carvacrol and Gelatin Sponge Sheet in people with Palatal Wound, run by British University In Egypt at 1 site in Egypt.
Trial summary
To evaluate the effect of carvacrol loaded to absorbable gelatin sponge as a palatal bandage on the palatal donor site in post-operative pain reduction after free gingival graft harvesting Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Palatal Wound
- What is being tested?
- Carvacrol and Gelatin Sponge Sheet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2024to 1 May 2025
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with mucogingival defects scheduled for free gingival graft.
- Medically free patients
- Palate with sufficient connective tissue to accommodate soft tissue defects.
- Good oral hygiene
Who cannot join
- Smokers
- Pregnancy
- Medically compromised patients
- Severe gag reflex
- Patients allergic to the used agent
- Occlusal trauma at the site of graft
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of Carvacrol Loaded Absorbable Gelatin Sponge as a Palatal Bandage After Free Gingival Graft Harvesting .
To evaluate the effect of carvacrol loaded to absorbable gelatin sponge as a palatal bandage on the palatal donor site in post-operative pain reduction after free gingival graft harvesting
- Conditions
- Palatal Wound
- Being tested
- Carvacrol, Gelatin Sponge Sheet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarvacrolOther
1-absorbable gelatine sponge soaked in carvacrol oil placed in the palatal donor site.
Procedure:
The palatal sites will be anaesthetized with 0.3 ml of a solution of 4% Articaine and 0.001% Adrenalin. Graft harvesting will be performed by basic surgical techniques previously described by Miller (1982). A rectangular shaped piece of mucosa will be harvested from the area of the hard palate by a split-thickness dissection.
The graft will then be used as it on the recipient bed. The graft dimensions will be recorded (width and length). Denuded palatal area will then be protected using a carvacrol loaded absorbable gelatin sponge (test group)
Gelatin Sponge SheetOther
Absorbable gelatin sponge placed in the palatal donor site
Procedure:
The palatal sites will be anaesthetized with 0.3 ml of a solution of 4% Articaine and 0.001% Adrenalin. Graft harvesting will be performed by basic surgical techniques previously described by Miller (1982). A rectangular shaped piece of mucosa will be harvested from the area of the hard palate by a split-thickness dissection.
The graft will then be used as it on the recipient bed. The graft dimensions will be recorded (width and length). Denuded palatal area will then be protected using a absorbable gelatin sponge(control group).
| Study group | Role | What they receive |
|---|---|---|
| Test Group | Experimental | Absorbable gelatin sponge soaked in carvacrol oil Receives: Other: Carvacrol |
| Control Group | Active comparator | Gelatin Sponge Receives: Other: Gelatin Sponge Sheet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-Operative Pain
Pain score reported by the patient directly through Visual Analogue Scale score (between 0 and 10. 0: no pain, 1: minimal pain, 5:moderate pain, 10: severe pain)
Measured: 2 weeks
Secondary outcomes (3)
Color Match
On day 3, day 7, day 14, day 21 and day 42, the color of the palatal mucosa will be assessed by comparing it with that of the adjacent and opposite side by using the objective VAS (VAS score 0-10) represented by a continuous line, by a clinician blinded to the treatment group assignment.
A score of 0 indicates no color match, and a score of 10 indicates excellent color match with the adjacent tissues
Measured: 42 days
Wound Size
To be recorded using (UNC15) periodontal probe to the nearest measurement of 0.5 mm at surgery day, day 3, day 7, day 14 and day 21
Measured: 21 days
Post-Operative Pain (Indirectly)
Postoperative pain, number of analgesic pills taken, and number of days pills were taken were assessed using questionnaires administered at the 3-day and 3-week postoperative appointments.
Measured: 3 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2025
- Study start1 Feb 2024
- Primary completion1 May 2025
- Study completion1 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Palatal WoundStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- British University In Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amin, British University In Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06806566
- Sponsor's protocol ID
- 23-011
- Status last verified
- Apr 2026
- First submitted
- 3 Feb 2025
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Carvacrol Loaded Absorbable Gelatin Sponge as a Palatal Bandage After Free Gingival Graft Harvesting .
- ClinicalTrials.gov ID
- NCT06806566
- Acronym / sponsor ID
- 23-011
- Conditions
- Palatal Wound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- British University In EgyptUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 4 Feb 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.
To evaluate the effect of carvacrol loaded to absorbable gelatin sponge as a palatal bandage on the palatal donor site in post-operative pain reduction after free gingival graft harvesting
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Group | Experimental | Other: CarvacrolAbsorbable gelatin sponge soaked in carvacrol oil |
| Control Group | Active comparator | Other: Gelatin Sponge SheetGelatin Sponge |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients with mucogingival defects scheduled for free gingival graft.
- Medically free patients
- Palate with sufficient connective tissue to accommodate soft tissue defects.
- Good oral hygiene
Key exclusion criteria (6 listed)
- Smokers
- Pregnancy
- Medically compromised patients
- Severe gag reflex
- Patients allergic to the used agent
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 |
|---|---|---|
| Carvacrol1-absorbable gelatine sponge soaked in carvacrol oil placed in the palatal donor site. Procedure: The palatal sites will be anaesthetized with 0.3 ml of a solution of 4% Articaine and 0.001% Adrenalin. Graft harvesting will be performed by basic surgical techniques previously described by Miller (1982). A rectangular shaped piece of mucosa will be harvested from the area of the hard palate by a split-thickness dissection. The graft will then be used as it on the recipient bed. The graft dimensions will be recorded (width and length). Denuded palatal area will then be protected using a carvacrol loaded absorbable gelatin sponge (test group) | Other | Test Group |
| Gelatin Sponge SheetAbsorbable gelatin sponge placed in the palatal donor site Procedure: The palatal sites will be anaesthetized with 0.3 ml of a solution of 4% Articaine and 0.001% Adrenalin. Graft harvesting will be performed by basic surgical techniques previously described by Miller (1982). A rectangular shaped piece of mucosa will be harvested from the area of the hard palate by a split-thickness dissection. The graft will then be used as it on the recipient bed. The graft dimensions will be recorded (width and length). Denuded palatal area will then be protected using a absorbable gelatin sponge(control group). | Other | Control Group |
Primary outcome
Post-Operative Pain
Time frame: 2 weeks
Pain score reported by the patient directly through Visual Analogue Scale score (between 0 and 10. 0: no pain, 1: minimal pain, 5:moderate pain, 10: severe pain)
3 secondary outcomes
Color Match
Time frame: 42 days
Wound Size
Time frame: 21 days
Post-Operative Pain (Indirectly)
Time frame: 3 Weeks
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 6 Apr 2026.
- Individual participant dataSharing planned: Undecided
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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 Carvacrol and Gelatin Sponge Sheet in people with Palatal Wound, run by British University In Egypt 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 6 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 6 Apr 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. 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?
Post-Operative Pain (time frame: 2 weeks). 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 6 Apr 2026.