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

NCT05819632 | Unknown DMC

• 1 other identifier: CairoU28122022
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Palate; Wound

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Soft tissue healing of the palatal wound

  up to three weeks post-operative

• Re-epithelization of the palatal wound

  up to three weeks post-operative

Study Arms (2)

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)

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)

Other: curcumin gel 2%

Interventions

curcumin gel 2% OTHER

curcumin gel 2%

curcumin gel; gelatine sponge

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry

Cairo, Manial, 12311, Egypt

RECRUITING

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

• tansim k abdelrahman, BDS

  master student

  PRINCIPAL INVESTIGATOR

• mohamed Atef, PHD

  Lecture of oral medicine and periodontology, faculty of dentistry ,Cairo university

  STUDY DIRECTOR

• manal m hosny, phd

  Professor of oral medicine and periodontology factuality of Dentistry,Cairo university

  STUDY CHAIR

Central Study Contacts

Tansim k ABdelrahman, BDS

CONTACT

+201001086940; tansim.khaled@denistry.cu.edu.eg

mohamed atef, PHD

CONTACT

+201224302609; mohamed.atef@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: masters degree candidate

Study Record Dates

• First Submitted: March 3, 2023
• First Posted: April 19, 2023
• Study Start: November 1, 2022
• Primary Completion: February 1, 2024
• Study Completion: April 1, 2024
• Last Updated: April 19, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)