Powered vs. Manual Toothbrushing in Stage 3-4 Periodontitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Powered, Manual.
- Who it may be relevant to
- Registry conditions: Periodontitis, Dental Plaque, Gingival Bleeding. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Efficacy of Powered Versus Manual Toothbrushes on Full-Mouth Bleeding and Plaque Scores in Patients With Stage 3 or 4 Periodontitis
Overview
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.
Interventions
- 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 - 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 press
Primary outcome measures
- Full-Mouth Bleeding Score (FMBS) [Time frame: FMBS will be assessed at baseline and at 7 days, 1 month, 3 months, and 6 months following the intervention.]
Secondary outcome measures (1)
- Systolic and Diastolic Blood Pressure (SBP and DBP) [Time frame: SBP and DBP will be measured at baseline, 1 month, 3 months, and 6 months.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
Italy · 1 center
- University of L'Aquila — L’Aquila
Identifiers
NCT: NCT06980714 · Verb n. 25 del 14/09/22 Addend