Incidence Assessment of Gingival Fissures Associated with the Use of Manual and Electric Toothbru… (NCT06651723) | Clinical Trial Compass
UnknownNot Applicable
Incidence Assessment of Gingival Fissures Associated with the Use of Manual and Electric Toothbrushes
Brazil34 participantsStarted 2023-07-10
Plain-language summary
Gingival fissures (GF) have been suggested as risk indicators for clinical attachment loss (CAL) and gingival recession, especially in free surfaces and in patients with low plaque scores. The major factors related to the GF occurrence are high daily brushing frequencies, excessive force to brush, malpositioned teeth, use of abrasive dentifrices, and stiffness of the toothbrushes bristles. Thus, in order to better understand the pathogenesis and progression of GF, this study aim to evaluate the incidence of GF in young adults using manual and electric soft toothbrushes, in a cross-over randomized clinical trial along 2 months.
Who can participate
Age range
14 Years – 25 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:
Good systemic health (ASA I and II); No history of periodontitis (no interproximal bone loss ≥ 3 mm); No gingival recession ≥ 3 mm; Minimum number of 20 teeth.
Exclusion Criteria:
Use of medications that alter in some way the gingival and/or periodontal inflammatory response (phenytoin, sodium valproate, nifedipine, verapramil, diltiazem amlodipine, felodipine, cyclosporine \[Murakami et al., 2018\]); Having had antibiotic therapy in the last three months; Crowding; Presence of restorations and/or carious lesions in the cervical region on the buccal surfaces; Being under orthodontic treatment; Type 1 or 2 Diabetes Mellitus; Being a smoker; Being pregnant; Presence of full crowns and/or implants; Need for antibiotic prophylaxis for periodontal examination;
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
Gingival fissures
Timeframe: From enrollment to the end of experimental time (2 months)