NCT07520994

Efficacy of Devices in Maintaining Oral Health and Managing Periodontal and Interproximal Tissues: a RCT

Clinical Efficacy of Various Devices in Maintaining Oral Health and Managing Periodontal Tissues and Interproximal Spaces During Home Oral Hygiene Procedures: a Randomized Controlled Clinical Trial

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: University of Roma La Sapienza · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study was conducted as a randomized controlled clinical trial with a crossover design in patients affected by gingivitis. All data were anonymized by assigning a unique identification code to each participant. Subjects were selected according to predefined inclusion and exclusion criteria. Patients aged between 18 and 65 years with interdental spaces suitable for the use of interdental brushes were included. At baseline (T0), all patients underwent a periodontal clinical examination, including assessment of clinical indices and documentation of initial conditions. A professional oral hygiene session was also performed using ultrasonic instruments and air flow with glycine powder. Patients received instructions for home oral hygiene using a two-tone plaque disclosing agent to highlight areas of greater cleaning difficulty. Initial intraoral conditions were documented photographically. At the end of the session, each patient was assigned to one of two treatment groups. Randomization was performed by coin toss. All patients were provided with a supply of interdental brushes and received standardized instructions for their use. After collecting clinical indices at baseline (T0), six evaluation time points (T1-T6) were scheduled at 30-day intervals. At each time point, the following clinical parameters were recorded: * Full Mouth Plaque Score (FMPS) * Interdental Plaque Index * Full Mouth Bleeding Score (FMBS) * Papillary Bleeding Index Measurements were performed using a standardized millimeter periodontal probe (PCP UNC 15) and a plaque disclosing agent. At T3 (90 days), a crossover of the interdental devices between the two groups was performed: patients in Group 1 replaced the rubber interdental brush with the bristle device and vice versa. Subsequent clinical assessments were conducted using the same methods until the end of the study (T6). During each follow-up visit, a clinical reassessment was performed, including removal of any residual plaque using air polishing if necessary. At the end of the study (T6), in addition to recording clinical indices and final photographic documentation, participants completed a 17-item questionnaire designed to assess device acceptability, frequency and method of use, and knowledge of interdental devices. All collected data were recorded digitally and processed for descriptive and comparative statistical analyses between the two treatments.

Conditions

• Gingivitis
• Gum Disease
• Oral Health

Interventions

Type	Name	Description
DEVICE	Group 1: use of the rubber interdental brush (picks) at baseline for 3 months	Group 1: use of the rubber interdental brush (picks) at baseline for 3 months, followed by use of the traditional bristle interdental brush for an additional 3 months.
DEVICE	Group 2: use of the traditional bristle interdental brush at baseline for 3 months	Group 2: use of the traditional bristle interdental brush at baseline for 3 months, followed by use of the rubber interdental brush for an additional 3 months

Timeline

• Start date: 2023-09-01
• Primary completion: 2025-11-01
• Completion: 2026-04-30
• First posted: 2026-04-09
• Last updated: 2026-04-09

Locations

1 site across 1 country: Italy