The Effect of Retraction Cord on the Surrounding Periodontal Tissues in Restorative Treatment (NCT07734935) | Clinical Trial Compass
CompletedNot Applicable
The Effect of Retraction Cord on the Surrounding Periodontal Tissues in Restorative Treatment
Turkey (Türkiye)10 participantsStarted 2025-02-18
Plain-language summary
The goal of this clinical trial is to learn whether a retraction cord affects gum health when used during tooth restoration procedures. A retraction cord is a thin thread that dentists sometimes place between the tooth and the gum surrounding it, to gently push the gum aside so the restoration can be performed in a clean surface isolated from saliva.
The study includes adult teeth with tooth damage near the gumline that has not been caused by decay, yet needs a restoration. The main research question is: Does using a retraction cord make a difference for gum health as opposed to not using one? Participants will be assigned into four separate groups. Two groups will receive a restoration with one type of bonding material, either with or without a retraction cord. The other two groups will receive a restoration with a different kind of bonding material, either with or without a retraction cord.
Researchers will check gum health status before the restorations and again on days 1, 7, and 28. They will observe symptoms such as swelling in the gums, bleeding of the gums, and gum margin positions. A fluid sample from the area between the gum and tooth will be collected to test for molecules of inflammation.
Who can participate
Age range
18 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:
* Age 18 years or older
* Systemically healthy
* Non-smoker
* Periodontally healthy (whole-mouth bleeding on probing \<10%, mean probing pocket depth ≤3 mm, mean Plaque Index and Gingival Index ≤1.1)
* At least 20 teeth in occlusion (full/near-full dentition)
* At least 4 non-carious cervical lesions, each ≥1 mm in depth, involving both enamel and dentin, with vital pulp status
Exclusion Criteria:
* Presence of systemic disease
* Use of medication known to affect inflammatory response during the study period
* Inability or unwillingness to comply with follow-up visits
* Pregnancy or lactation
* Current smoking
* Presence of periodontal disease
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
Change in Split-Mouth Gingival Index Difference (ΔGI) Over Time
Timeframe: Baseline, and Days 1, 7, and 28 after restoration