Efficacy of Devices in Maintaining Oral Health and Managing Periodontal and Interproximal Tissues (NCT07520994) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Efficacy of Devices in Maintaining Oral Health and Managing Periodontal and Interproximal Tissues
Italy40 participantsStarted 2023-09-01
Plain-language summary
The aim of the study was to assess the acceptability of the assisted individual and compliance with home use, as well as their clinical impact on the plaque index (PI) and bleeding on probing (BOP), with monthly reassessments allowing for continuous monitoring of all parameters.
Who can participate
Age range
18 Years – 50 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 between 18 and 50 years
* Interdental spaces suitable for the use of interdental brushes
Exclusion Criteria:
* Age below 18 or above 50 years
* Presence of periodontitis
* Presence of generalized diastemas
* Presence of removable prostheses or orthodontic appliances
* Presence of tremors or reduced mobility of the upper limbs; adequate oculomotor coordination required
* Type 1 or type 2 diabetes
* Immunodeficiency or immunocompromised conditions (e.g., HIV infection)
* Pregnancy or breastfeeding
* Hormonal therapy
* Current pharmacological therapy with drugs known to cause gingival hyperplasia, such as phenytoin, cyclosporine, and calcium channel blockers
* Psychiatric disorders
* Heavy smoking (\>10 cigarettes/day)
* Alcohol or drug abuse
* Xerostomia
* Patients with fixed dental implants
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
Full mouth bleeding score
Timeframe: From baseline (T0) to the end of the study at 180 days, with follow-up assessments every 30 days (T1-T6).
2
Full mouth plaque score
Timeframe: From baseline (T0) to the end of the study at 180 days, with follow-up assessments every 30 days (T1-T6).