Alternative Gingival De-Epithelialization Techniques

January 14, 2026 updated by: Sandra Hyon Mi Stuhr, University of Michigan

Alternative Gingival De-Epithelialization Techniques: A Randomized Controlled Trial

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?

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan School of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Histomorphometric Comparison
Time Frame: After Day 0 (Baseline surgery)
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 Frame: Day 0 (Baseline Surgery)
Time spent removing the epithelium (in minutes)
Day 0 (Baseline Surgery)
Patient-reported outcome measures
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.
Days 1, 7, 14, 21 (Post-operative) after surgery
Wound healing
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.
Days 1, 7, 14, 21 (Post-operative) after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Collaborators

Delta Dental Foundation

Investigators

  • Principal Investigator: Sandra Stuhr, DMD, MS, University of Michigan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 4, 2024

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

July 5, 2023

First Submitted That Met QC Criteria

July 12, 2023

First Posted (Actual)

July 17, 2023

Study Record Updates

Last Update Posted (Estimated)

January 16, 2026

Last Update Submitted That Met QC Criteria

January 14, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM00231789

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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