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

NCT ID: NCT06806566

Last Updated: 2025-02-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-01

Study Completion Date

2025-05-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Palatal Wound

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Biostatistician

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Test Group

Absorbable gelatin sponge soaked in carvacrol oil

Group Type EXPERIMENTAL

Carvacrol

Intervention Type 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)

Control Group

Gelatin Sponge

Group Type ACTIVE_COMPARATOR

Gelatin Sponge Sheet

Intervention Type 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).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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)

Intervention Type 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).

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

British University In Egypt

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Amin

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The british university in egypt

Cairo, , Egypt

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Amin I. Amin, Bachelors degree in dentisrty

Role: CONTACT

+201099922346

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Amin i. Amin, Bachelors degree in dentistry

Role: primary

+201099922346

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

23-011

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Effect of I-PRF After Gingivectomy
NCT07174934 NOT_YET_RECRUITING NA