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
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Fase
- Fase 4
Contacten en locaties
Studiecontact
- Naam: José López-López, Doctor
- Telefoonnummer: 0034-606457362
- E-mail: jl.lopez@ub.edu
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Crossover-opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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
|
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.
|
|
Actieve vergelijker: 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
|
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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Plaque Index (O'Leary Plaque Control Record)
Tijdsspanne: 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.
|
Baseline and after each 3-week intervention period (up to 9 weeks).
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Gingival Bleeding Index
Tijdsspanne: Baseline and after each 3-week intervention period (up to 9 weeks).
|
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
Tijdsspanne: Baseline and after each 3-week intervention period (up to 9 weeks).
|
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
Tijdsspanne: Baseline and after each 3-week intervention period (up to 9 weeks).
|
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)
Tijdsspanne: Baseline and after each 3-week intervention period (up to 9 weeks).
|
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).
|
Medewerkers en onderzoekers
Sponsor
Medewerkers
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- toothbrush01
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
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product vervaardigd in en geëxporteerd uit de V.S.
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