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Enrolling by Invitation

NCT Number: NCT05947305

Alternative Gingival De-Epithelialization Techniques

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?

Enrolling by Invitation

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan School of Dentistry

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Surgical Blade

Procedure

Using a 15c blade to de-epithelialize the soft tissue extra-orally

Mucotome

Procedure

Using Megagen Mucotome to de-epithelialize the soft tissue intra-orally

Diamond Bur

Procedure

Using a surgical diamond bur to de-epithelialize the soft tissue intra-orally

Er:YAG laser

Procedure

Using an Er:YAG Laser to de-epithelialize the soft tissue intra-orally

Primary outcomes

  1. 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

Secondary outcomes

  1. Surgical Time

    Time frame: Day 0 (Baseline Surgery)

    Time spent removing the epithelium (in minutes)

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • Delta Dental Foundation

Registry information

Official study title

Alternative Gingival De-Epithelialization Techniques: A Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 17, 2023
Registry last updated
Jan 16, 2026

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.

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