Properties of Absorbable and Nonabsorbable Suture Material in Dental Surgery (NCT04234308) | Clinical Trial Compass
UnknownNot Applicable
Properties of Absorbable and Nonabsorbable Suture Material in Dental Surgery
200 participantsStarted 2020-03
Plain-language 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.
Who can participate
Age range
20 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
healing changes around each suture material
Timeframe: 1 week, 2 weeks 1 month and 3 months after surgery.
2
Tensile and mechanical properties of each suture material
Timeframe: following 1 week of clinical application.
3
Biofilm formation around each suture material
Timeframe: following 1 week of clinical application.