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NCT Number: NCT05717985

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

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

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Key information

Conditions

Gingival Recession Gingival Diseases Mouth Diseases Periodontal Atrophy Periodontal Diseases Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry

Kuala Lumpur, 50300, Malaysia

Location status: Recruiting

Location contact

Nik Madihah Nik Azis, DClinDent

CONTACT

[email protected]

603-9289 7741

About this study

Harvesting a palatal mucosal tissue graft as an autologous donor for oral soft tissue augmentation is widely practiced. Tissue harvest in patients with anatomically thin phenotypes can cause significant morbidity and compromised healing process. The modified combined approach (MCA) for connective tissue grafts has the potential for faster healing and fewer postoperative complications, compared to the recommended harvesting technique of de-epithelized gingival graft (DGG). However, the modified combined approach for connective tissue grafts have yet to be extensively investigated.

This examiner-masked, randomized study aims to compare post-operative morbidity and treatment outcomes in patients undergoing modified combined approach for connective tissue graft (test group) compared to the de-epithelized gingival graft (control group) harvesting techniques in tissue augmentation.

Participants will be randomized into two groups receiving one of either modified combined approach for connective tissue graft or de-epithelized gingival graft. Collection of the study parameters will utilize both examiner-assessed, and patient reported outcomes.

The study will report on the optimum palatal mucosal graft harvesting technique in an Asian population. The findings of this study will be utilized to formulate clinical recommendations for soft tissues augmentation in this population.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

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.

de-epithelized gingival graft

Procedure

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

Primary outcomes

  1. Pain after gingival graft harvesting

    Time frame: up to 3 months after surgery

    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.

Secondary outcomes

  1. Healing after gingival graft harvesting

    Time frame: up to 3 months after surgery

    Measured clinically by the investigators. The donor site will be inspected and scored using the Wound Healing Index (Landry et. al, 1988). The photograph of the donor site will also be taken and analysed digitally to measure the amount of keratinisation using the ImageJ Software. Higher score on the Wound Healing Index is a better outcome (minimum score= 0, maximum score= 5). Higher amount of keratinised tissue as measured by the software is a better outcome (minimum value= 0, maximum value= the full surface of the donor site estimated at 3200 square mm).

Study contacts

Contact information is provided by the study sponsor or research team.

Nik Madihah Nik Azis, DClinDent

CONTACT

[email protected]

603-9289 7741

Sponsors and collaborators

Lead sponsor

National University of Malaysia

Other

Registry information

Official study title

A Randomized Controlled Trial to Compare De-epithelized Connective Tissue Grafts and Modified Combined Approach for Connective Tissue Grafts

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Feb 8, 2023
Registry last updated
Dec 2, 2024

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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