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

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.

Study Overview

• Status: Recruiting
• Conditions: Palate; Wound
• Intervention / Treatment: Other: curcumin gel 2%

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tansim k ABdelrahman, BDS; Phone Number: +201001086940; Email: tansim.khaled@denistry.cu.edu.eg
• Study Contact Backup: Name: mohamed atef, PHD; Phone Number: +201224302609; Email: mohamed.atef@dentistry.cu.edu.eg

Study Locations

• Egypt
  • Manial
    • Cairo, Manial, Egypt, 12311
      • Recruiting
      • Faculty of Dentistry
      • Contact: mohamed atef, phd; Phone Number: +201224302609; Email: mohamed.atef@dentistry.ci.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Systematically healthy patient (American Society of Anesthesiology class I and II).
2. Male or female
3. Patients with mucogingival defects scheduled for free gingival graft.
4. Patients with good oral hygiene.

Exclusion Criteria:

1. Patients with any uncontrolled local or systemic disease where periodontal plastic surgery might be contraindicated.
2. History of recent periodontal surgery at the donor site.
3. Smokers.
4. Pregnancy and lactation.
5. Patients allergic to the used agents,
6. Severe gagging reflex.
7. Inability or unwillingness to provide informed consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
post-operative pain	post -operative pain measured by visual analouge scale from 0 (no pain) to 10 (highest pain value)	one week post operative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	up to three weeks post-operative
Re-epithelization of the palatal wound	Re-epithelization of the palatal wound using H2O2 test	up to three weeks post-operative

Collaborators and Investigators

• Sponsor: 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 record dates

Study Major Dates

• Study Start (Actual): November 1, 2022
• Primary Completion (Anticipated): February 1, 2024
• Study Completion (Anticipated): April 1, 2024

Study Registration Dates

• First Submitted: March 3, 2023
• First Submitted That Met QC Criteria: April 15, 2023
• First Posted (Actual): April 19, 2023

Study Record Updates

• Last Update Posted (Actual): April 19, 2023
• Last Update Submitted That Met QC Criteria: April 15, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Antineoplastic Agents; Curcumin
• Other Study ID Numbers: CairoU28122022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No