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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- Phase 4
Contacts et emplacements
Coordonnées de l'étude
- Nom: José López-López, Doctor
- Numéro de téléphone: 0034-606457362
- E-mail: jl.lopez@ub.edu
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
|
|
Comparateur actif: 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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Plaque Index (O'Leary Plaque Control Record)
Délai: 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).
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Gingival Bleeding Index
Délai: 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
Délai: 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
Délai: 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)
Délai: 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).
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- toothbrush01
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
produit fabriqué et exporté des États-Unis.
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