Assessment of a Carvacrol-loaded Absorbable Gelatin Sponge Used as a Palatal Dressing Following Free Gingival Graft Harvesting.

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

Study Overview

• Status: Completed
• Conditions: Palatal Wound
• Intervention / Treatment: Other: Carvacrol; Other: Gelatin Sponge Sheet

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

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • The british university in egypt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Smokers
• Pregnancy
• Medically compromised patients
• Severe gag reflex
• Patients allergic to the used agent
• Occlusal trauma at the site of graft

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test Group; Absorbable gelatin sponge soaked in carvacrol oil	Other: Carvacrol; 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)
Active Comparator: Control Group; Gelatin Sponge	Other: Gelatin Sponge Sheet; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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.	3 Weeks

Collaborators and Investigators

• Sponsor: British University In Egypt

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2024
• Primary Completion (Actual): May 1, 2025
• Study Completion (Actual): May 1, 2025

Study Registration Dates

• First Submitted: February 3, 2025
• First Submitted That Met QC Criteria: February 3, 2025
• First Posted (Actual): February 4, 2025

Study Record Updates

• Last Update Posted (Actual): April 6, 2026
• Last Update Submitted That Met QC Criteria: April 1, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: carvacrol
• Other Study ID Numbers: 23-011

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No