Alternative Gingival De-Epithelialization Techniques

University of Michigan

Status: Invitation-only

Conditions: Recession, Gingival; Surgical Procedure, Unspecified; Wound Heal; Graft Complication

Treatments: Procedure: Surgical Blade; Procedure: Diamond Bur; Procedure: Er:YAG Laser; Procedure: Mucotome

Study type: Interventional

Funder types: Other

Identifiers

NCT05947305

HUM00231789

Details and patient eligibility

About

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?

Full 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.

Enrollment: 48 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

48 participants in 4 patient groups, including a placebo group

Surgical Blade

Placebo Comparator group

Description:

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

Treatment:

Procedure: Surgical Blade

Mucotome

Experimental group

Description:

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

Treatment:

Procedure: Mucotome

Diamond Bur

Experimental group

Description:

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

Treatment:

Procedure: Diamond Bur

Er:YAG Laser

Experimental group

Description:

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

Treatment:

Procedure: Er:YAG Laser