Assessment of a Carvacrol-loaded Absorbable Gelatin Sponge Used As a Palatal Dressing Following Free Gingival Graft Harvesting: a Randomized Clinical Study

Not Applicable

Recruiting

• Conditions: Palatal Wound

• Registration Number: NCT06806566
• Lead Sponsor: British University In Egypt

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-01
• Status Verified: 2025-02
• Study First Submitted: 2025-02-03
• Study First Submitted QC: 2025-02-03
• Last Update Submitted: 2025-02-03
• Study First Posted: 2025-02-04
• Last Update Posted: 2025-02-04
• Primary Completion: 2025-05-01
• Study Completion: 2025-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1 - Patients with mucogingival defects scheduled for free gingival graft. 2- Medically free patients 3- Palate with sufficient connective tissue to accommodate soft tissue defects. 4- Good oral hygiene

Exclusion Criteria

1 - Smokers 2- Pregnancy 3- Medically compromised patients 4- Severe gag reflex 5- Patients allergic to the used agent 6- Occlusal trauma at the site of graft

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Post-Operative Pain	2 weeks	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)

Secondary Outcome Measures

Name	Time	Method
Color Match	42 days	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
Wound Size	21 days	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
Post-Operative Pain (Indirectly)	3 Weeks	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.

Trial Locations

Locations (1)

The british university in egypt; 🇪🇬 Cairo, Egypt