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Clinical Trials in Italy / NCT06980714
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Powered vs. Manual Toothbrushing in Stage 3-4 Periodontitis

NCT06980714 · tracked via the Priya Life Science Italy tracker
Phase
Not applicable
Started
2024-11-01
Last updated
2025-05-20

Condition(s) studied

PeriodontitisDental PlaqueGingival Bleeding

Investigational drug(s) / intervention(s)

PoweredManual

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.

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: * Adults aged 18 to 75 years * Diagnosis of stage 3 or 4 periodontitis based on clinical and radiographic examination * Retaining at least 16 natural teeth * Ability to follow oral hygiene instructions and compliance with the study protocol * Willingness to refrain from using additional oral hygiene products (e.g., mouthwash, interdental cleaners) during the study * Ability to provide informed consent Exclusion Criteria: * Presence of systemic conditions that may affect oral health (e.g., uncontrolled diabetes, immunocompromised states) * Pregnancy or breastfeeding * Ongoing use of antibiotics or other medications that could interfere with gum health * Severe dental conditions (e.g., tooth mobility \> 2, advanced root resorption) * Prior use of a powered toothbrush within the last 6 months * Participation in another clinical trial that could interfere with study outcomes * Inability or unwillingness to comply with study requirements or provide informed consent

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
University of L'Aquila L’Aquila Italy

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06980714 on ClinicalTrials.gov ↗ ← All trials in Italy