A Randomized Crossover Clinical Trial Comparing a Sonic Toothbrush Versus an Oscillating-rotating Toothbrush on Plaque Control and Gingival Health
Trial Snapshot
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
- University of Barcelona
- Enrollment
- 24
- Primary Endpoint
- Plaque Index (O'Leary Plaque Control Record)
Study Overview
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.
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Masking Description
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
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
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
Intervention: sonic toothbrush (Device)
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
Intervention: sonic toothbrush (Device)
Outcomes
Primary Outcomes
Plaque Index (O'Leary Plaque Control Record)
Time Frame: Baseline and after each 3-week intervention period (up to 9 weeks).
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.
Secondary Outcomes
- 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).)
Investigators
Sonia Egido Moreno
doctor
University of Barcelona