Sonic Toothbrush Versus an Oscillating-rotating Toothbrush on Plaque Control and Gingival Health

NCT07651982 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: toothbrush01
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

Objective:To evaluate the usefulness of a sonic toothbrush compared to an electric toothbrush for plaque removal and improving gingival health.Patients:Patients over 18 years of age who attend the Master's Degree in Medicine, Surgery and Oral Implantology of the HOUB or other clinical activities of the group cooperating with the study, who comply with the follow-up, and sign the informed consent.Material and method:A randomized clinical trial will be conducted.

Conditions

Plaque Control; Gingival Health

Keywords

sonic; toothbrush; oscillating

Outcome Measures

Primary Outcomes (1)

• Plaque Index (O'Leary Plaque Control Record)

  Change in the percentage of tooth surfaces with dental plaque, assessed using the O'Leary Plaque Control Record. Plaque presence will be recorded on four surfaces of each tooth after application of a plaque-disclosing agent. Results will be expressed as the percentage of surfaces with plaque.

  Baseline and after each 3-week intervention period (up to 9 weeks).

Secondary Outcomes (4)

• Gingival Bleeding Index

  Baseline and after each 3-week intervention period (up to 9 weeks).

• Salivary pH

  Baseline and after each 3-week intervention period (up to 9 weeks).

• Unstimulated Salivary Flow Rate

  Baseline and after each 3-week intervention period (up to 9 weeks).

• Total Bacterial Load (16S rRNA Quantification)

  Baseline and after each 3-week intervention period (up to 9 weeks).

Study Arms (2)

sonic toothbrush

EXPERIMENTAL

Participants will be instructed to brush their teeth twice daily for 2 minutes using the assigned sonic toothbrush. Standardized oral hygiene instructions will be provided at the beginning of the phase

Device: sonic toothbrush

Oscillating toothbrush

ACTIVE COMPARATOR

Participants will be instructed to brush their teeth twice daily for 2 minutes using the assigned oscillating-rotating electric toothbrush . Standardized oral hygiene instructions will be provided at the beginning of the phase

Device: sonic toothbrush

Interventions

sonic toothbrush DEVICE

Participants will use a powered sonic toothbrush for 3 weeks as part of a randomized crossover study. Subjects will be instructed to brush twice daily (morning and evening) for 2 minutes using a standardized fluoridated toothpaste provided by the investigators. Standardized oral hygiene instructions will be given at the beginning of each intervention period. No antiseptic mouthwashes or additional intensive oral hygiene devices will be allowed during the study period.

Oscillating toothbrush; sonic toothbrush

Eligibility Criteria

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

You may qualify if:

• Willing and able to comply with study procedures and follow-up visits. Provision of written informed consent.

You may not qualify if:

• Moderate or severe periodontitis requiring immediate treatment. Fixed orthodontic appliances. Use of systemic antibiotics or antiseptic mouthwashes (e.g., chlorhexidine) within 4 weeks prior to enrollment.
• Pregnancy or breastfeeding. Participants unable to cooperate with study procedures due to psychomotor dysfunction or behavioral disorders.

Sponsors & Collaborators

• University of Barcelona: lead
• Hospital Odontològic UB: collaborator

Central Study Contacts

José López-López, Doctor

CONTACT

0034-606457362; jl.lopez@ub.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the interventions, participants and investigators cannot be blinded to the toothbrush assigned. However, the outcome assessor and data analyst will be fully blinded to treatment allocation to minimize bias
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor

Study Record Dates

• First Submitted: June 7, 2026
• First Posted: June 16, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): October 15, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: June 16, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share