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Alternative Gingival De-Epithelialization Techniques

Primary Purpose

Recession, Gingival, Surgical Procedure, Unspecified, Graft Complication

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Surgical Blade
Mucotome
Diamond Bur
Er:YAG Laser
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recession, Gingival

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Michigan School of Dentistry

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

Surgical Blade

Mucotome

Diamond Bur

Er:YAG Laser

Arm Description

A surgical blade will be used to de-epithelialize gum tissue during the subject's regularly scheduled dental surgery.

A mucotome will be used to de-epithelialize gum tissue during the subject's regularly scheduled dental surgery.

A diamond bur will be used to de-epithelialize gum tissue during the subject's regularly scheduled dental surgery.

A dental laser will be used to de-epithelialize gum tissue during the subject's regularly scheduled dental surgery.

Outcomes

Primary Outcome Measures

Histomorphometric Comparison
Histomorphometric evaluation of the relative proportion of epithelial tissue remnants (percentage) after de-epithelialization of the CTG

Secondary Outcome Measures

Surgical Time
Time spent removing the epithelium (in minutes)
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.
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.

Full Information

First Posted
July 5, 2023
Last Updated
September 12, 2023
Sponsor
University of Michigan
Collaborators
Delta Dental Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT05947305
Brief Title
Alternative Gingival De-Epithelialization Techniques
Official Title
Alternative Gingival De-Epithelialization Techniques: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
July 1, 2024 (Anticipated)
Study Completion Date
September 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
Delta Dental Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recession, Gingival, Surgical Procedure, Unspecified, Graft Complication, Wound Heal

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Surgical Blade
Arm Type
Placebo Comparator
Arm Description
A surgical blade will be used to de-epithelialize gum tissue during the subject's regularly scheduled dental surgery.
Arm Title
Mucotome
Arm Type
Experimental
Arm Description
A mucotome will be used to de-epithelialize gum tissue during the subject's regularly scheduled dental surgery.
Arm Title
Diamond Bur
Arm Type
Experimental
Arm Description
A diamond bur will be used to de-epithelialize gum tissue during the subject's regularly scheduled dental surgery.
Arm Title
Er:YAG Laser
Arm Type
Experimental
Arm Description
A dental laser will be used to de-epithelialize gum tissue during the subject's regularly scheduled dental surgery.
Intervention Type
Procedure
Intervention Name(s)
Surgical Blade
Intervention Description
Using a 15c blade to de-epithelialize the soft tissue extra-orally
Intervention Type
Procedure
Intervention Name(s)
Mucotome
Intervention Description
Using Megagen Mucotome to de-epithelialize the soft tissue intra-orally
Intervention Type
Procedure
Intervention Name(s)
Diamond Bur
Intervention Description
Using a surgical diamond bur to de-epithelialize the soft tissue intra-orally
Intervention Type
Procedure
Intervention Name(s)
Er:YAG Laser
Intervention Description
Using an Er:YAG Laser to de-epithelialize the soft tissue intra-orally
Primary Outcome Measure Information:
Title
Histomorphometric Comparison
Description
Histomorphometric evaluation of the relative proportion of epithelial tissue remnants (percentage) after de-epithelialization of the CTG
Time Frame
After Day 0 (Baseline surgery)
Secondary Outcome Measure Information:
Title
Surgical Time
Description
Time spent removing the epithelium (in minutes)
Time Frame
Day 0 (Baseline Surgery)
Title
Patient-reported outcome measures
Description
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.
Time Frame
Days 1, 7, 14, 21 (Post-operative) after surgery
Title
Wound healing
Description
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.
Time Frame
Days 1, 7, 14, 21 (Post-operative) after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alice Ou, RDH, MS
Phone
7347633346
Email
aliceou@umich.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Sandra Stuhr, DMD, MS
Phone
7347633346
Email
sstuhr@umich.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandra Stuhr, DMD, MS
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan School of Dentistry
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sandra Stuhr, DMD, MS

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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31461778
Citation
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24640997
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PubMed Identifier
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Citation
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Alternative Gingival De-Epithelialization Techniques

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