University of Michigan School of Dentistry
Ann Arbor, Michigan, 48109, United States
NCT Number: NCT05947305
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?
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Ann Arbor, Michigan, 48109, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Using an Er:YAG Laser to de-epithelialize the soft tissue intra-orally
Time frame: After Day 0 (Baseline surgery)
Histomorphometric evaluation of the relative proportion of epithelial tissue remnants (percentage) after de-epithelialization of the CTG
Time frame: Day 0 (Baseline Surgery)
Time spent removing the epithelium (in minutes)
Time frame: 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.
Time frame: 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.
University of Michigan
Other
Alternative Gingival De-Epithelialization Techniques: A Randomized Controlled Trial
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.
Published trials that share one or more normalized conditions with this study.
NCT05470660
Gingival Diseases, Gingival Recession
Cairo, Egypt
View Trial DetailsNCT07349056
Buccal Bone Thickness, Dental Surgery
Edirne, Turkey (Türkiye)
View Trial DetailsNCT06037161
Gingival Diseases, Gingival Recession
Cleveland, Ohio, United States
View Trial DetailsNCT05565079
Gingival Diseases, Gingival Recession
Louisville, Kentucky, United States
View Trial Details