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

14. juni 2026 oppdatert av: Sonia Egido Moreno, University of Barcelona

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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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

Intervensjonell

Registrering (Antatt)

24

Fase

  • Fase 4

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

  • Navn: José López-López, Doctor
  • Telefonnummer: 0034-606457362
  • E-post: jl.lopez@ub.edu

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Ja

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Crossover-oppdrag
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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
Enhet: 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.
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
Enhet: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Plaque Index (O'Leary Plaque Control Record)
Tidsramme: 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).

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Gingival Bleeding Index
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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).

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of Barcelona

Samarbeidspartnere

Hospital Odontològic UB

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

15. juni 2026

Primær fullføring (Antatt)

15. oktober 2026

Studiet fullført (Antatt)

15. desember 2026

Datoer for studieregistrering

Først innsendt

7. juni 2026

Først innsendt som oppfylte QC-kriteriene

14. juni 2026

Først lagt ut (Faktiske)

16. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

16. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

14. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • toothbrush01

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produkt produsert i og eksportert fra USA

Nei

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