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?
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
48
Using a 15c blade to de-epithelialize the soft tissue extra-orally
Using Megagen Mucotome to de-epithelialize the soft tissue intra-orally
Using a surgical diamond bur to de-epithelialize the soft tissue intra-orally
University of Michigan School of Dentistry
Ann Arbor, Michigan, United States
Histomorphometric Comparison
Histomorphometric evaluation of the relative proportion of epithelial tissue remnants (percentage) after de-epithelialization of the CTG
Time frame: After Day 0 (Baseline surgery)
Surgical Time
Time spent removing the epithelium (in minutes)
Time frame: Day 0 (Baseline Surgery)
Patient-reported outcome measures
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.
Time frame: Days 1, 7, 14, 21 (Post-operative) after surgery
Wound healing
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.
Time frame: Days 1, 7, 14, 21 (Post-operative) after surgery
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Using an Er:YAG Laser to de-epithelialize the soft tissue intra-orally