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
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Fas 4
Kontakter och platser
Studiekontakt
- Namn: José López-López, Doctor
- Telefonnummer: 0034-606457362
- E-post: jl.lopez@ub.edu
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
|
Aktiv komparator: 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Plaque Index (O'Leary Plaque Control Record)
Tidsram: 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).
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Gingival Bleeding Index
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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).
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
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Nyckelord
Andra studie-ID-nummer
- toothbrush01
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