Clinical trial NCT04234308: Properties of Absorbable and Nonabsorbable Suture Material in Dental Surgery
Official title: Clinical, Mechanical, and Histological Properties of Absorbable and Nonabsorbable Suture Materials Used in Periodontal and Dental Implant Surgery.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Suture Adverse Reaction
Suture; Complications, Mechanical
Suture Failure During Surgical Operation
Suture Related Complication
Suture Rupture
Suture; Complications, Infection or Inflammation
Suture Line Infection
Keywords: dental suture
suture infection
Mechanical properties
absorbable sutures
non-absorbable sutures
histological properties
Lead sponsor: Universidad Científica del Sur
Sponsor class: OTHER
Collaborators: name: New York University
First posted: 2020-01-21
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: A suture is a biomedical device that is made of natural or synthetic materials. Sutures are used to close tissue surfaces until wounds heal and regain their ability to withstand normal stresses. Although different suture materials are available for various dental procedures, clinicians commonly neglect to select sutures based on their mechanical properties and capabilities. Instead, clinicians rely on their clinical experience to determine which suture material will suffice for wound closure and healing. To our knowledge, there have been no published studies detailing the results of mechanical testing on sutures after clinical application. The aim of this study is to clinically, histologically, and mechanically assess the four common sutures used in periodontal and dental surgery, with the hopes of providing clinicians with a guide that will allow them to choose sutures based on the clinical, histological, mechanical properties that best fit the stress and strain applied to the wound.


Eligibility criteria: Inclusion Criteria:

Subject must have read, understood and signed the informed consent form. Subject must require either open flap debridement surgery or implant placement (one to three consecutive teeth replacement) surgery.

Subjects must be males or females who are a minimum of 20 years of age. No history of periodontal or implant surgery at the investigational area site within the past 12 months.

Periodontal probing depths ≥5 mm interdentally at the implant site. Subjects that received single interrupted sutures for flap closure following surgical procedures.

Exclusion Criteria:

* Subject is part of a vulnerable population will be excluded. Female subjects who are pregnant or lactating, or who intend to become pregnant during the study period following entrance into the study.

Subjects with a systemic disease that would preclude periodontal surgery. Subjects who are smokers or chew tobacco. Subjects that received periodontal dressing on the surgical area. Subjects with the presence of acute infectious lesions in the areas intended for surgery.

Subjects with conditions or circumstances, in the opinion of the Investigator, which would prevent completion of study participation or interfere with analysis of study results.

Primary outcomes:
measure: healing changes around each suture material
timeFrame: 1 week, 2 weeks 1 month and 3 months after surgery.
measure: Tensile and mechanical properties of each suture material
timeFrame: following 1 week of clinical application.
measure: Biofilm formation around each suture material
timeFrame: following 1 week of clinical application.
Secondary outcomes:
measure: complications including erythema, edema, hematoma, infection, wound dehiscence, keloid or scar tissue
timeFrame: 1 week, 2 weeks, 1 month and 3 months after surgery.
measure: plaque adherence over sutures, number of sutures present and number of stable (untied) sutures
timeFrame: 1 week after surgery.
measure: subject satisfaction
timeFrame: 1 week and 3 months following surgery.
Other outcomes:
Locations:
Study officials:
affiliation: New York University
name: Ismael Khouly, PhD
role: PRINCIPAL_INVESTIGATOR
References: