Alternative Gingival De-Epithelialization Techniques

Not Applicable

• Conditions: Recession, Gingival; Wound Heal; Surgical Procedure, Unspecified; Graft Complication
• Interventions: Procedure: Mucotome; Procedure: Diamond Bur; Procedure: Surgical Blade

• Registration Number: NCT05947305
• Lead Sponsor: University of Michigan

Brief Summary

The goal of this clinical trial is to compare different de-epithelialization methods in patients undergoing soft tissue augmentation surgery. The main questions it aims to answer are:

• Which technique is superior for de-epithelialization in terms of remaining epithelium, wound healing of the donor site, and clinical outcomes?

Detailed Description

Participants will be randomly assigned to one of four surgical techniques during their surgical procedure and the wound site will be assessed on post-operative days 1, 7, 14, and 21.

Researchers will compare the use of mucotome, Er:YAG laser, surgical diamond bur, or blade to observe patterns of wound healing and assess if one method is superior in terms of removing the epithelium.

Study Timeline

• Study First Submitted: 2023-07-05
• Study First Submitted QC: 2023-07-12
• Study First Posted: 2023-07-17
• Study Start: 2024-04-04
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-04
• Last Update Posted: 2024-11-06
• Primary Completion: 2025-09-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• American Society of Anesthesiologists (ASA) Physical Status Classification I or II
• Subjects undergoing periodontal surgical procedures that involve harvesting of soft tissue samples, who have a treatment plan including the use or removal of keratinized mucosa or subepithelial connective tissue that will not require additional anesthesia for sample collection
• Adequate physical and mental health to undergo routine dental treatment
• Ability and willingness to follow instructions related to the study procedures

Exclusion Criteria

• Poorly controlled diabetes, defined as HbA1c >/= 7.0
• Autoimmune or inflammatory conditions such as systemic lupus erythematous, rheumatoid arthritis.
• Pregnant women or nursing mothers, or unsure of pregnancy status (self-reported)
• Severe hematologic disorders, such as leukemia or hemophilia
• Subjects on anticoagulant or antiplatelet therapy
• Local or systemic infection that may interfere with healing
• Hepatic or renal diseases
• Currently under cancer treatment or within 18 months from completion of radio- or chemotherapy
• History of antibiotic or immunosuppressant use in the last 3 months
• Subjects on concomitant drug therapy for systemic conditions that may affect outcomes of the study
• Current smokers (CDC definition): heavy smokers: subjects who have smoked >10 cigarettes per day within 6 months of study onset, and have smoked >100 cigarettes in their lifetime

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mucotome	Mucotome	A mucotome will be used to de-epithelialize gum tissue during the subject's regularly scheduled dental surgery.
Diamond Bur	Diamond Bur	A diamond bur will be used to de-epithelialize gum tissue during the subject's regularly scheduled dental surgery.
Surgical Blade	Surgical Blade	A surgical blade will be used to de-epithelialize gum tissue during the subject's regularly scheduled dental surgery.

Primary Outcome Measures

Name	Time	Method
Histomorphometric Comparison	After Day 0 (Baseline surgery)	Histomorphometric evaluation of the relative proportion of epithelial tissue remnants (percentage) after de-epithelialization of the CTG

Secondary Outcome Measures

Name	Time	Method
Wound healing	Days 1, 7, 14, 21 (Post-operative) after surgery	Wound healing comparisons using a clinical healing index (CHI) developed by Pippi et al 2015 will be completed. The possible total score is 7 (ideal score demonstrating ideal healing = 0), with scores for each section being dichotomous (0 or 1). Parameters related to clinical inspection include: mucosal color, granulation tissue, epithelialization degree, and swelling. Palpation parameters include bleeding, pain, and suppuration.
Surgical Time	Day 0 (Baseline Surgery)	Time spent removing the epithelium (in minutes)
Patient-reported outcome measures	Days 1, 7, 14, 21 (Post-operative) after surgery	Patient-reported outcome measures regarding pain and discomfort after the procedure using a line scale (from no pain to worst pain imaginable), box scale (ranging from 0-10 with 0 being no pain and 10 being worst pain imaginable), and a verbal rating scale (no pain, slightly painful, moderately painful, very painful, extremely painful). The number of analgesics (along with dosage) taken during the post-operative period will be recorded.

Trial Locations

Locations (1)

University of Michigan School of Dentistry; 🇺🇸 Ann Arbor, Michigan, United States