NCT06980714

Powered vs. Manual Toothbrushing in Stage 3-4 Periodontitis

Efficacy of Powered Versus Manual Toothbrushes on Full-Mouth Bleeding and Plaque Scores in Patients With Stage 3 or 4 Periodontitis

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: University of L'Aquila · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study compares the effectiveness of powered and manual toothbrushes in reducing gum bleeding and dental plaque in people with stage 3 or 4 periodontitis. All participants are trained to brush for at least two minutes twice a day. The goal is to find out whether using a powered toothbrush leads to better oral hygiene results than a manual one, when brushing time is standardized. The study will measure bleeding and plaque levels at the beginning and over a 6-month period.

Detailed description

This single-blind, randomized controlled trial evaluates the clinical effectiveness of powered versus manual toothbrushing in patients newly diagnosed with stage 3 or 4 periodontitis. Participants are randomly assigned to one of two groups: powered toothbrush (Oral-B iO6) or manual toothbrush (TePe Select Soft). All participants receive standardized oral hygiene instructions and are instructed to brush twice daily for a minimum of two minutes. Manual brush users are required to use a smartphone app to monitor and record brushing duration. The use of adjunctive oral hygiene aids, such as mouthwash or interdental cleaners, is restricted throughout the study period. The primary clinical outcomes are full-mouth bleeding score (FMBS) and full-mouth plaque score (FMPS), measured at baseline and at follow-ups of 7 days, 1 month, 3 months, and 6 months.

Conditions

• Periodontitis
• Dental Plaque
• Gingival Bleeding

Interventions

Type	Name	Description
BEHAVIORAL	Powered	The intervention involves the use of the Oral-B iO6 powered toothbrush, which provides oscillating-rotating brushing action with personalized feedback via its smart pressure sensor and app integration. Participants in this group are instructed to brush for at least two minutes twice daily. The toothbrush is designed to ensure consistent brushing performance, with real-time feedback on brushing technique and duration, allowing for improved oral hygiene habits. The intervention aims to standardize brushing duration and technique, eliminating potential variations found with manual brushing.
BEHAVIORAL	Manual	The intervention involves the use of the TePe Select Soft manual toothbrush, which features soft bristles for gentle yet effective plaque removal. Participants in this group are instructed to brush for at least two minutes twice daily, with guidance on proper brushing technique. To ensure compliance with the brushing duration, participants are required to use a smartphone app that tracks and records their brushing sessions. The manual toothbrush allows for participant control over brushing pressure and technique, with no additional oral hygiene aids allowed during the study period.

Timeline

• Start date: 2024-11-01
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2025-05-20
• Last updated: 2025-05-20

Locations

1 site across 1 country: Italy