Powered vs. Manual Toothbrushing in Stage 3-4 Periodontitis

University of L'Aquila

Status: Invitation-only

Conditions: Periodontitis; Dental Plaque; Gingival Bleeding

Treatments: Behavioral: Manual; Behavioral: Powered

Study type: Interventional

Funder types: Other

Identifiers

NCT06980714

Verb n. 25 del 14/09/22 Addend

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups

Manual

Active Comparator group

Description:

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.

Treatment:

Behavioral: Manual

Powered

Experimental group

Description:

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.

Treatment:

Behavioral: Powered