Alternative Gingival De-Epithelialization Techniques

Launched by UNIVERSITY OF MICHIGAN · Jul 12, 2023

Keywords

ClinConnect Summary

This clinical trial is testing four different ways to remove the outer layer of gum tissue (the epithelium) during a gum/graft procedure to see which method helps healing best and what the final results are like. It’s a randomized study, meaning you would be assigned by chance to one of four techniques: surgical blade (standard method), mucotome, diamond bur, or an Er:YAG laser. The researchers will compare how much epithelial tissue remains after the procedure and how the donor site heals, as well as practical details like how long the surgery takes and how much pain you have after surgery.

Who can join? Adults 18 years and older who are generally healthy (no serious conditions and ASA I or II) and are planning periodontal surgery that involves taking soft tissue grafts, without needing extra anesthesia just for sampling. Exclusions include poorly controlled diabetes, certain autoimmune or inflammatory diseases, pregnancy, heavy smoking, active infections, liver or kidney disease, recent cancer treatment, and several other health factors. The study is at the University of Michigan in Ann Arbor and is currently enrolling by invitation. If enrolled, you’ll have post-operative follow-ups on days 1, 7, 14, and 21 to report pain and assess healing. The trial has not yet reported results.

Gender

ALL

Eligibility criteria

• 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