Evaluation of De-epithelized Connective Tissue Grafts and Modified Combined Approach for Connective Tissue Grafts

NCT05717985 | Recruiting

• 1 other identifier: GGPM-2022-024
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to compare the de-epithelized gingival graft (control group) and modified combined approach for connective tissue graft (test group) in patients undergoing palatal graft harvesting for mucogingival surgery in the oral cavity

Conditions

Gingival Recession

Outcome Measures

Primary Outcomes (1)

• Pain after gingival graft harvesting

  Measured using a self-reported questionnaire that is designed by the research group. The pain will be measured using a visual analogue score (minimum value=0 and maximum value=10), and using a surrogate measure of amount of painkillers taken by the participants after the surgery (minimum value= 0, maximum value= 2 grams for paracetamol, 1200 mg for ibuprofen). Higher score on the visual analogue scale and higher amount of painkillers taken is a worst outcome.

  up to 3 months after surgery

Secondary Outcomes (1)

• Healing after gingival graft harvesting

  up to 3 months after surgery

Study Arms (2)

de-epithelized gingival graft

ACTIVE COMPARATOR

A type of mucogingival surgery where a gingival graft is harvested from the palate, prepared chairside and placed on a recipient site to augment it. Dressing material and sutures is placed at the donor site.

Procedure: de-epithelized gingival graft

modified combined approach

EXPERIMENTAL

A type of mucogingival surgery where a gingival graft is harvested from the palate, prepared chairside and placed on a recipient site to augment it. A part of the prepared tissues namely the epithelial layer is replaced at the donor site and sutured.

Procedure: modified combined approach

Interventions

modified combined approach PROCEDURE

A thin layer of epithelium will be excised from the harvested graft. This epithelium will be replaced at the donor site and sutured.

modified combined approach

de-epithelized gingival graft PROCEDURE

Only dressing material will be placed at the donor site after graft harvesting

de-epithelized gingival graft

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• systemically healthy subjects;
• able to give informed consent;
• age ≥ 18 years;
• requiring palatal tissue harvesting for soft tissue augmentation in the oral cavity

You may not qualify if:

• subjects with periodontal diseases;
• subjects with poor oral hygiene of \>30% plaque index;
• pregnant or lactating females;
• subjects taking medication with any known effect on the periodontal soft tissues;
• subjects with pathology in the oral cavity causing any degree of pain;
• subjects wearing removable or fixed prothesis that is in contact with the donor site an
• those with allergies to painkillers including ibuprofen and paracetamol.

Sponsors & Collaborators

• National University of Malaysia: lead

Study Sites (1)

Faculty of Dentistry

Kuala Lumpur, 50300, Malaysia

RECRUITING

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Study Officials

• Nik Madihah Nik Azis, DClinDent

  Faculty of Dentistry, University Kebangsaan Malaysia

  STUDY DIRECTOR

Central Study Contacts

Nik Madihah Nik Azis, DClinDent

CONTACT

603-9289 7741; nikmadihah@ukm.edu.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2023
• First Posted: February 8, 2023
• Study Start: February 22, 2023
• Primary Completion: June 1, 2025
• Study Completion: September 1, 2025
• Last Updated: December 2, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)