Clinical trial NCT05947305: Alternative Gingival De-Epithelialization Techniques
Official title: Alternative Gingival De-Epithelialization Techniques: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Recession, Gingival
Surgical Procedure, Unspecified
Graft Complication
Wound Heal
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Delta Dental Foundation
First posted: 2023-07-17
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Histomorphometric Comparison
timeFrame: After Day 0 (Baseline surgery)
Secondary outcomes:
measure: Surgical Time
timeFrame: Day 0 (Baseline Surgery)
measure: Patient-reported outcome measures
timeFrame: Days 1, 7, 14, 21 (Post-operative) after surgery
measure: Wound healing
timeFrame: Days 1, 7, 14, 21 (Post-operative) after surgery
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan School of Dentistry
state: Michigan
Study officials:
affiliation: University of Michigan
name: Sandra Stuhr, DMD, MS
role: PRINCIPAL_INVESTIGATOR
References:
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