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 range18 Years – 50 Years

SexALL

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

What they're measuring

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).

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).

Trial details

NCT IDNCT07520994

SponsorUniversity of Roma La Sapienza

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-11-01

View on ClinicalTrials.gov More Gingivitis trials