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Completed

NCT Number: NCT06806566

Assessment of a Carvacrol-loaded Absorbable Gelatin Sponge Used as a Palatal Dressing Following 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

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Key information

Conditions

Palatal Wound

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The british university in egypt

Cairo, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

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).

Primary outcomes

  1. Post-Operative Pain

    Time frame: 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 outcomes

  1. Color Match

    Time frame: 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

  2. Wound Size

    Time frame: 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

  3. Post-Operative Pain (Indirectly)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

British University In Egypt

Other

Registry information

Official study title

Clinical Evaluation of Carvacrol Loaded Absorbable Gelatin Sponge as a Palatal Bandage After Free Gingival Graft Harvesting .

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 4, 2025
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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