Sonic Toothbrush Versus an Oscillating-rotating Toothbrush on Plaque Control and Gingival Health
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Barcelona
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Crossover
Treatments tested in this trial
sonic toothbrush
DeviceParticipants 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.
Treatment groups
24 Participants
are divided into 2 treatment groupsGroup A: sonic toothbrushExperimental treatment 1 intervention
Group B: Oscillating toothbrushActive comparator 1 intervention
Trial outcomes
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.
Time frame
Baseline and after each 3-week intervention period (up to 9 weeks).Secondary outcomes
1
Gingival Bleeding Index
Change in gingival inflammation assessed using the Silness and Löe Gingival Index, based on color changes, edema, and bleeding on probing.
Time frame
Baseline and after each 3-week intervention period (up to 9 weeks).2
Salivary pH
Change in salivary pH measured using pH indicator strips applied to unstimulated saliva samples collected under standardized conditions
Time frame
Baseline and after each 3-week intervention period (up to 9 weeks).3
Unstimulated Salivary Flow Rate
Change in unstimulated salivary flow rate (mL/min), measured by collecting saliva for 5 minutes in a sterile container.
Time frame
Baseline and after each 3-week intervention period (up to 9 weeks).4
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.
Time frame
Baseline and after each 3-week intervention period (up to 9 weeks).Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Barcelona
Lead sponsor
Hospital Odontològic UB
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: