Assessment of Gingival Health Following Rubber-Dam Isolation (NCT05850065) | Clinical Trial Compass
UnknownNot Applicable
Assessment of Gingival Health Following Rubber-Dam Isolation
Turkey (Türkiye)30 participantsStarted 2023-03-10
Plain-language summary
The aim of this study is to evaluate the effect of retraction techniques on gingival health. Four different method (212 clamp (Hu-Friedy, USA); Brinker B4 clamp (Coltene Hygenic, USA); dental floss using the simple knot tie method; and using the simple knot tie and 212 clamp together) will evaluated. After rubber dam isolation restorations will be performed, each restoration will take maximum 30 minutes.
Changes in periodontal tissues will be evaluate; using plaque index, bleeding on probing, probing depth, keratinized gingiva, attached gingiva, relative gingival margin level, relative attachment level and VAS (visual analogue scale) scoring and patient comfort levels after the procedure at different times (pre-restoration, after restoration, 1 week, 1 month, 3 month). The evaluation time is planned not to exceed 10 minutes, restorations are done by a single specialist in Marmara University Restorative Dentistry Department.
Who can participate
Age range
18 Years – 35 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:
* Between the ages of 18-35
* Have sufficient cognitive ability to understand the consent procedure
* Clinically healthy gingiva and periodontium
* Daily cigarette consumption of 10 or less
* No attachment loss, bleeding on probing, or plaque buildup
* Vital upper teeth (12-22) without signs of irreversible pulpitis
* Patients with cervical lesions, abrasion lesions and/or indications for diastema closure requiring restoration
* Patients with cervical lesions at or below the gingival level
* Patients with direct composite restoration indications concerning the cervical region in their upper anterior 4 incisors.
Exclusion Criteria:
* Any disability (mental health conditions, mentally handicapped and physically handicapped)
* Systemic diseases or serious medical risks (Cardiovascular disorder, diabetes, hypertensive, epileptic)
* Compliance problem, inability to provide post-treatment hygiene
* Gingival hyperplasia or bleeding disorder
* Signs of attachment loss of periodontal disease
* Patients for whom rubber dam placement is contraindicated (patient with asthma diagnosis, mouth breathing, partially erupted tooth, overly malpositioned teeth and latex allergy).
* Signs of periapical pathology or pulpal posterior or anterior pathology
* Non-vital, endodontically treated teeth
* Teeth which have mobility
* Teeth with extraction indication
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.