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

NCT06806566 | Recruiting

• 1 other identifier: 23-011
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Palatal Wound

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Color Match

  42 days

• Wound Size

  21 days

• Post-Operative Pain (Indirectly)

  3 Weeks

Study Arms (2)

Test Group

EXPERIMENTAL

Absorbable gelatin sponge soaked in carvacrol oil

Other: Carvacrol

Control Group

ACTIVE COMPARATOR

Gelatin Sponge

Other: Gelatin Sponge Sheet

Interventions

Carvacrol OTHER

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)

Test Group

Gelatin Sponge Sheet OTHER

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).

Control Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• British University In Egypt: lead

Study Sites (1)

The british university in egypt

Cairo, Egypt

RECRUITING

MeSH Terms

Interventions

carvacrol

Central Study Contacts

Amin I. Amin, Bachelors degree in dentisrty

CONTACT

+201099922346; PG.Amin92142017@bue.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Biostatistician
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 3, 2025
• First Posted: February 4, 2025
• Study Start: February 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: February 4, 2025

Record last verified: 2025-02

Locations

EG (1)