Alternative Gingival De-Epithelialization Techniques (NCT05947305) | Clinical Trial Compass
By InvitationNot Applicable
Alternative Gingival De-Epithelialization Techniques
United States48 participantsStarted 2024-04-04
Plain-language 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?
Who can participate
Age range18 Years
SexALL
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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