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Alternative Gingival De-Epithelialization Techniques

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05947305
Recruitment Status : Enrolling by invitation
First Posted : July 17, 2023
Last Update Posted : May 1, 2024
Sponsor:
Collaborator:
Delta Dental Foundation
Information provided by (Responsible Party):
Sandra Hyon Mi Stuhr, University of Michigan

Study Description
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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?


Condition or disease Intervention/treatment Phase
Recession, Gingival Surgical Procedure, Unspecified Graft Complication Wound Heal Procedure: Surgical Blade Procedure: Mucotome Procedure: Diamond Bur Procedure: Er:YAG Laser Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Alternative Gingival De-Epithelialization Techniques: A Randomized Controlled Trial
Actual Study Start Date : April 4, 2024
Estimated Primary Completion Date : October 1, 2024
Estimated Study Completion Date : December 1, 2024
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05947305


Locations
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United States, Michigan
University of Michigan School of Dentistry
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Delta Dental Foundation
Investigators
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Principal Investigator: Sandra Stuhr, DMD, MS University of Michigan
More Information
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Publications of Results:

Other Publications:

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Responsible Party: Sandra Hyon Mi Stuhr, Clinical Assistant Professor of Dentistry, Periodontics and Oral Medicine, University of Michigan
ClinicalTrials.gov Identifier: NCT05947305    
Other Study ID Numbers: HUM00231789
First Posted: July 17, 2023    Key Record Dates
Last Update Posted: May 1, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Gingival Recession
Gingival Diseases
Periodontal Diseases
 Mouth Diseases
Stomatognathic Diseases
Periodontal Atrophy