Alternative Gingival De-Epithelialization Techniques

Study Overview
=================
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.

Official Title
-----------------
Alternative Gingival De-Epithelialization Techniques: A Randomized Controlled Trial

Conditions
-----------------
Recession, Gingival, Surgical Procedure, Unspecified, Graft Complication, Wound Heal

Intervention / Treatment
-----------------
* Procedure: Surgical Blade
* Procedure: Mucotome
* Procedure: Diamond Bur
* Procedure: Er:YAG Laser


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Surgical Blade<br>A surgical blade will be used to de-epithelialize gum tissue during the subject's regularly scheduled dental surgery. | Procedure: Surgical Blade<br>* Using a 15c blade to de-epithelialize the soft tissue extra-orally<br>|
| Experimental: Mucotome<br>A mucotome will be used to de-epithelialize gum tissue during the subject's regularly scheduled dental surgery. | Procedure: Mucotome<br>* Using Megagen Mucotome to de-epithelialize the soft tissue intra-orally<br>|
| Experimental: Diamond Bur<br>A diamond bur will be used to de-epithelialize gum tissue during the subject's regularly scheduled dental surgery. | Procedure: Diamond Bur<br>* Using a surgical diamond bur to de-epithelialize the soft tissue intra-orally<br>|
| Experimental: Er:YAG Laser<br>A dental laser will be used to de-epithelialize gum tissue during the subject's regularly scheduled dental surgery. | Procedure: Er:YAG Laser<br>* Using an Er:YAG Laser to de-epithelialize the soft tissue intra-orally<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Histomorphometric Comparison | Histomorphometric evaluation of the relative proportion of epithelial tissue remnants (percentage) after de-epithelialization of the CTG | After Day 0 (Baseline surgery) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical Time | Time spent removing the epithelium (in minutes) | 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. | 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. | Days 1, 7, 14, 21 (Post-operative) after surgery |