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

A Randomized Crossover Clinical Trial Comparing a Sonic Toothbrush Versus an Oscillating-rotating Toothbrush on Plaque Control and Gingival Health

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Plaque Control; Gingival Health
• Intervention / Treatment: Device: sonic toothbrush

Detailed Description

This study is a single-center, randomized, evaluator-blinded, 2×2 crossover clinical trial designed to compare the effectiveness of a sonic toothbrush and an oscillating-rotating powered toothbrush in improving oral hygiene and gingival health in adult participants.

Participants will be randomly assigned to one of two intervention sequences. Each intervention period will last three weeks and will be separated by a three-week washout period during which standardized oral hygiene measures will be used to minimize potential carryover effects. The total study duration for each participant will be nine weeks.

At baseline and follow-up visits, participants will undergo oral examinations and standardized assessments performed by a trained examiner blinded to the assigned toothbrush. Clinical and salivary measurements will be collected throughout the study according to the protocol schedule. Participants will receive standardized oral hygiene instructions and will be provided with the same fluoridated toothpaste for the entire study period. The use of additional antiseptic oral products or intensive oral hygiene devices will not be permitted during the intervention periods unless clinically indicated.

The study aims to generate updated clinical evidence regarding the comparative performance of two widely used powered-toothbrush technologies under controlled conditions. The crossover design allows each participant to serve as his or her own control, reducing inter-individual variability and increasing the precision of treatment comparisons.

The study will be conducted at the Hospital Odontològic Universitat de Barcelona (HOUB) in accordance with Good Clinical Practice principles, applicable regulatory requirements, and ethical standards for research involving human participants.

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: José López-López, Doctor; Phone Number: 0034-606457362; Email: jl.lopez@ub.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion criteria Adults aged 18 years or older. Able to perform daily oral hygiene independently. Presence of at least 20 natural teeth and/or implant-supported restorations. Patients attending the Master of Oral Medicine, Oral Surgery and Oral Implantology clinics at the Hospital Odontològic Universitat de Barcelona (HOUB).

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

Exclusion Criteria:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: sonic toothbrush; 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; 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.
Active Comparator: Oscillating toothbrush; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gingival Bleeding Index	Change in gingival inflammation assessed using the Silness and Löe Gingival Index, based on color changes, edema, and bleeding on probing.	Baseline and after each 3-week intervention period (up to 9 weeks).
Salivary pH	Change in salivary pH measured using pH indicator strips applied to unstimulated saliva samples collected under standardized conditions	Baseline and after each 3-week intervention period (up to 9 weeks).
Unstimulated Salivary Flow Rate	Change in unstimulated salivary flow rate (mL/min), measured by collecting saliva for 5 minutes in a sterile container.	Baseline and after each 3-week intervention period (up to 9 weeks).
Total Bacterial Load (16S rRNA Quantification)	Change in total salivary bacterial load determined by quantitative PCR (qPCR) quantification of the bacterial 16S rRNA gene, expressed as copies per mL of saliva.	Baseline and after each 3-week intervention period (up to 9 weeks).

Collaborators and Investigators

• Sponsor: University of Barcelona
• Collaborators: Hospital Odontològic UB

Study record dates

Study Major Dates

• Study Start (Estimated): June 15, 2026
• Primary Completion (Estimated): October 15, 2026
• Study Completion (Estimated): December 15, 2026

Study Registration Dates

• First Submitted: June 7, 2026
• First Submitted That Met QC Criteria: June 14, 2026
• First Posted (Actual): June 16, 2026

Study Record Updates

• Last Update Posted (Actual): June 16, 2026
• Last Update Submitted That Met QC Criteria: June 14, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: toothbrush; oscillating; sonic
• Other Study ID Numbers: toothbrush01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No