curcumin: Clinical Comparison of Application of Curcumin Gel in Pain Management After Free Gingival Graft Harvesting

Sponsor

Cairo University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05819632

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Palate; Wound	Other: curcumin gel 2%	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

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

Actual Study Start Date :

Nov 1, 2022

Anticipated Primary Completion Date :

Feb 1, 2024

Anticipated Study Completion Date :

Apr 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: curcumin gel 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)	Other: curcumin gel 2% curcumin gel 2%
Active Comparator: gelatine sponge 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)	Other: curcumin gel 2% curcumin gel 2%

Arm

Intervention/Treatment

Experimental: curcumin gel

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)

Other: curcumin gel 2%

curcumin gel 2%

Active Comparator: gelatine sponge

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)

Other: curcumin gel 2%

curcumin gel 2%

Outcome Measures

Primary Outcome Measures

post-operative pain [one week post operative]
post -operative pain measured by visual analouge scale from 0 (no pain) to 10 (highest pain value)

Secondary Outcome Measures

Soft tissue healing of the palatal wound [up to three weeks post-operative]
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
Re-epithelization of the palatal wound [up to three weeks post-operative]
Re-epithelization of the palatal wound using H2O2 test

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Dentistry	Cairo	Manial	Egypt	12311

Sponsors and Collaborators

Cairo University

Investigators

Principal Investigator: tansim k abdelrahman, BDS, master student
Study Director: mohamed Atef, PHD, Lecture of oral medicine and periodontology, faculty of dentistry ,Cairo university
Study Chair: manal m hosny, phd, Professor of oral medicine and periodontology factuality of Dentistry,Cairo university

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Tansim Khaled Tawfik Abdelrahman, masters degree candidate, Cairo University

ClinicalTrials.gov Identifier:

NCT05819632

Other Study ID Numbers:

CairoU28122022

First Posted:

Apr 19, 2023

Last Update Posted:

Apr 19, 2023

Last Verified:

Apr 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Curcumin

Study Results

No Results Posted as of Apr 19, 2023