Powered vs. Manual Toothbrushing in Stage 3-4 Periodontitis

NCT06980714 | Enrolling By Invitation

• 1 other identifier: Verb n. 25 del 14/09/22 Addend
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Periodontitis; Dental Plaque; Gingival Bleeding

Keywords

Periodontitis; Full-Mouth Plaque Score; Full-Mouth Bleeding Score; Home Oral Hygiene

Outcome Measures

Primary Outcomes (1)

• Full-Mouth Bleeding Score (FMBS)

  The Full-Mouth Bleeding Score (FMBS) will be used to assess the level of gingival bleeding upon gentle probing across all teeth in the mouth. This measure will evaluate the overall gum health of participants and will help compare the effectiveness of the powered versus manual toothbrushes in reducing gingival inflammation. FMBS will be recorded at baseline, 7 days, 1 month, 3 months, and 6 months to monitor changes in bleeding over time.

  FMBS will be assessed at baseline and at 7 days, 1 month, 3 months, and 6 months following the intervention.

Secondary Outcomes (1)

• Systolic and Diastolic Blood Pressure (SBP and DBP)

  SBP and DBP will be measured at baseline, 1 month, 3 months, and 6 months.

Study Arms (2)

Manual

ACTIVE COMPARATOR

Participants assigned to this arm use a manual toothbrush (TePe Select Soft) to perform twice-daily toothbrushing for at least 2 minutes. Brushing technique and duration are standardized through individual instruction at baseline. Participants are instructed not to use any additional oral hygiene aids, including mouthwash or interdental cleaners. Brushing sessions are monitored and recorded via a smartphone app to ensure compliance with the 2-minute minimum duration.

Behavioral: Manual

Powered

EXPERIMENTAL

Participants assigned to this arm use a powered toothbrush (Oral-B iO6) to perform twice-daily toothbrushing for at least two minutes. Brushing technique and duration are standardized through individual instruction at baseline. Participants are instructed not to use any additional oral hygiene aids, including mouthwash or interdental cleaners. The powered toothbrush provides consistent brushing performance, and participants are monitored to ensure compliance with the 2-minute minimum duration.

Behavioral: Powered

Interventions

Powered BEHAVIORAL

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.

Powered

Manual BEHAVIORAL

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.

Manual

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of L'Aquila: lead

Study Sites (1)

University of L'Aquila

L’Aquila, 67100, Italy

Location

MeSH Terms

Conditions

Periodontitis; Dental Plaque; Gingival Hemorrhage

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Dental Deposits; Tooth Diseases; Oral Hemorrhage; Gingival Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Davide Pietropaoli, DDS, PhD

  University of L'Aquila

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The clinical investigator who interacts with participants and the outcomes assessor responsible for evaluating clinical indices (FMBS and FMPS) are both blinded to group allocation. Participants are instructed not to disclose the type of toothbrush they are using. The masking helps ensure unbiased data collection and outcome assessment throughout the study.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI Davide Pietropaoli, Professor

Model Details: Participants are randomly assigned in a 1:1 ratio to either a powered toothbrush group or a manual toothbrush group. Each group follows the same oral hygiene protocol, with standardized brushing instructions. The two groups are followed in parallel over a 6-month period without crossover.

Study Record Dates

• First Submitted: May 8, 2025
• First Posted: May 20, 2025
• Study Start: November 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 20, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Time Frame: Starting 12 months after publication; available for 3 years
• Access Criteria: Researchers with a methodologically sound proposal and ethics approval

Locations

IT (1)