Palate; WoundcurcuminNCT05819632
Clinical Comparison of Application of Curcumin Gel in Pain Management After Free Gingival Graft Harvesting
A study testing curcumin gel 2% in people with Palate; Wound, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of this study is to compare the effect of using 2% curcumin gel versus gelatin sponge when applied to palatal donor site in pain management and wound healing after free gingival graft harvesting. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Palate; Wound
- What is being tested?
- curcumin gel 2%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2022to 1 Apr 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Systematically healthy patient (American Society of Anesthesiology class I and II).
- Male or female
- Patients with mucogingival defects scheduled for free gingival graft.
- Patients with good oral hygiene.
Who cannot join
- Patients with any uncontrolled local or systemic disease where periodontal plastic surgery might be contraindicated.
- History of recent periodontal surgery at the donor site.
- Smokers.
- Pregnancy and lactation.
- Patients allergic to the used agents,
- Severe gagging reflex.
- Inability or unwillingness to provide informed consent.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dentistry
Cairo, Manial, 12311
mohamed atef, phd, +201224302609, mohamed.atef@dentistry.ci.edu.eg
About this study
Official title: Clinical Comparison of Topical Application of Curcumin Gel Versus Gelatin Sponge in Pain Management and Wound Healing After Free Gingival Graft Harvesting: a Randomized Controlled Clinical Trial
The aim of this study is to compare the effect of using 2% curcumin gel versus gelatin sponge when applied to palatal donor site in pain management and wound healing after free gingival graft harvesting.
- Conditions
- Palate; Wound
- Being tested
- curcumin gel 2%
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
curcumin gel 2%Other
curcumin gel 2%
| Study group | Role | What they receive |
|---|---|---|
| curcumin gel | Experimental | the denuded palatal area will be superficially covered with a continuous thin layer of curcumin gel 2% one time immediately after the surgery (curcumin gel will be prepared in 2% concentration on a carbapol base)according to (Bhatia et al., 2014) Receives: Other: curcumin gel 2% |
| gelatine sponge | Active comparator | absorbable gelatin sponge will be cut to the palatal wound size and applied. Following manual compression of the wound area, both agents will be secured in place using compressive palatal sling sutures.
commercial name (CUTANPLAST) Receives: Other: curcumin gel 2% |
What is being measured
The primary outcome is the main question the study is designed to answer.
post-operative pain
post -operative pain measured by visual analouge scale from 0 (no pain) to 10 (highest pain value)
Measured: one week post operative
Secondary outcomes (2)
Soft tissue healing of the palatal wound
Soft tissue healing of the palatal wound measured by Modified Landry's wound healing score from 1 indicates poorest healing to 5 indicates excellent healing
Measured: up to three weeks post-operative
Re-epithelization of the palatal wound
Re-epithelization of the palatal wound using H2O2 test
Measured: up to three weeks post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2023
- Study start1 Nov 2022
- Primary completion1 Feb 2024 (estimated)
- Study completion1 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Palate; WoundStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tansim Khaled Tawfik Abdelrahman, Cairo University
- Investigators
- tansim k abdelrahman, BDS, Principal investigator, master studentmohamed Atef, PHD, Study director, Lecture of oral medicine and periodontology, faculty of dentistry ,Cairo universitymanal m hosny, phd, Study chair, Professor of oral medicine and periodontology factuality of Dentistry,Cairo university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05819632
- Sponsor's protocol ID
- CairoU28122022
- Acronym
- curcumin
- Status last verified
- Apr 2023
- First submitted
- 3 Mar 2023
- Last updated
- 19 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Comparison of Topical Application of Curcumin Gel Versus Gelatin Sponge in Pain Management and Wound Healing After Free Gingival Graft Harvesting: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05819632
- Acronym / sponsor ID
- curcumin / CairoU28122022
- Conditions
- Palate; Wound
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 1 Feb 2024 (estimated)
- Study completion
- 1 Apr 2024 (estimated)
- First posted
- 19 Apr 2023 (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 study is to compare the effect of using 2% curcumin gel versus gelatin sponge when applied to palatal donor site in pain management and wound healing after free gingival graft harvesting.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| curcumin gel | Experimental | Other: curcumin gel 2%the denuded palatal area will be superficially covered with a continuous thin layer of curcumin gel 2% one time immediately after the surgery (curcumin gel will be prepared in 2% concentration on a carbapol base)according to (Bhatia et al., 2014) |
| gelatine sponge | Active comparator | Other: curcumin gel 2%absorbable gelatin sponge will be cut to the palatal wound size and applied. Following manual compression of the wound area, both agents will be secured in place using compressive palatal sling sutures. commercial name (CUTANPLAST) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Systematically healthy patient (American Society of Anesthesiology class I and II).
- Male or female
- Patients with mucogingival defects scheduled for free gingival graft.
- Patients with good oral hygiene.
Key exclusion criteria (7 listed)
- Patients with any uncontrolled local or systemic disease where periodontal plastic surgery might be contraindicated.
- History of recent periodontal surgery at the donor site.
- Smokers.
- Pregnancy and lactation.
- Patients allergic to the used agents,
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 |
|---|---|---|
| curcumin gel 2%curcumin gel 2% | Other | curcumin gel, gelatine sponge |
Primary outcome
post-operative pain
Time frame: one week post operative
post -operative pain measured by visual analouge scale from 0 (no pain) to 10 (highest pain value)
2 secondary outcomes
Soft tissue healing of the palatal wound
Time frame: up to three weeks post-operative
Re-epithelization of the palatal wound
Time frame: up to three weeks post-operative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2023.
- Individual participant dataSharing planned: No
Related trials for Palate; Wound
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Clinical and Histological Evaluation of Subepithelial Connective Tissue Graft Maturation at Different Healing Timepoints, With and Without Topical Application of a Polynucleotide- and Hyaluronic Acid-Based Gel
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Clinical Comparison of Alb-PRF vs PRF on Postoperative Morbidity Following FGG Harvesting
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Effect of Cyanoacrylate Tissue Adhesive Versus Collagen Sponge on Palatal Donor Site Healing
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Palatal Mucosa Wound Healing Following Antimicrobial Gel Application
Wound Healing, Palate; Wound
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.
tansim k abdelrahman, BDS principal investigator
master student
mohamed Atef, PHD study director
Lecture of oral medicine and periodontology, faculty of dentistry ,Cairo university
manal m hosny, phd study chair
Professor of oral medicine and periodontology factuality 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 curcumin gel 2% in people with Palate; Wound, 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 7 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: status not confirmed, as of the sponsor's last update on 19 Apr 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tansim k ABdelrahman, BDS (+201001086940, tansim.khaled@denistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
post-operative pain (time frame: one week post operative). 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 19 Apr 2023; AzTrials last refreshed its copy on 8 Nov 2026.