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Guided Biofilm Therapy Versus Conventional Polishing for Tooth Re-Staining

28 août 2026 mis à jour par: Mehmet Ali Tuna, Ataturk University

Guided Biofilm Therapy Versus Conventional Polishing for Extrinsic Tooth Re-Staining, Patient Comfort, and Procedure Time: A Randomized Split-Mouth Trial

This study compared Guided Biofilm Therapy with conventional polishing in adults with visible extrinsic tooth staining. Each participant received Guided Biofilm Therapy on one side of the mouth and conventional polishing on the other side.

The study evaluated whether the two methods differed in the amount of tooth re-staining after treatment, patient discomfort during the procedures, and total procedure time. Tooth color was measured with a spectrophotometer immediately after treatment, at 1 month, and at 2 months. Patient discomfort was recorded using a visual analog scale, and procedure time was measured with a stopwatch.

A total of 34 participants completed the study.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

This randomized split-mouth clinical trial was conducted in adults with visible extrinsic tooth staining. The aim was to compare Guided Biofilm Therapy (GBT) with conventional polishing in terms of post-procedural extrinsic tooth re-staining, patient discomfort, and procedure time.

Each participant received both interventions. One side of the mouth was assigned to GBT and the contralateral side to conventional polishing. The right-left allocation of the interventions was determined by randomization, with the two allocation sequences equally distributed among participants.

In the GBT intervention, dental biofilm was first disclosed and then removed using an air-water-powder system with a low-abrasive erythritol-based powder. Supragingival ultrasonic instrumentation was performed where necessary. In the conventional polishing intervention, supragingival instrumentation was followed by mechanical polishing with a brush and polishing paste.

Tooth color was assessed using a SpectroShade Micro spectrophotometer and the CIELAB color system. Measurements were performed immediately after treatment at baseline (T0), at 1 month (T1), and at 2 months (T2). Color change between assessment periods was calculated using ΔE*ab values.

Patient-reported discomfort was assessed immediately after each half-mouth procedure using a visual analog scale. Total procedure time for each intervention was recorded with a stopwatch.

The primary outcome was color change from immediately after treatment to 2 months. Secondary outcomes included color change from immediately after treatment to 1 month, color change from 1 month to 2 months, patient discomfort, and procedure time.

A total of 34 participants completed all study visits and follow-up assessments.

Type d'étude

Interventionnel

Inscription (Réel)

34

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Turquie (Türkiye)
    • Erzurum
      • Erzurum, Erzurum, Turquie (Türkiye), 25080
        • Ataturk University

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Oui

La description

Inclusion Criteria:

  • Age over 18 years.
  • Willingness to participate in the study and provision of written informed consent.
  • Good general health with no systemic disease.
  • Clinical presence of extrinsic staining on tooth surfaces at a level warranting professional polishing.
  • Right-handed tooth brushing.
  • No professional dental cleaning within the previous 6 months.

Exclusion Criteria:

  • Age under 18 years.
  • Diagnosis of periodontitis.
  • Current smoking.
  • Antibiotic use within the previous 3 months.
  • Presence of acute periodontal disease.
  • Allergy to polishing powders, specifically erythritol.
  • Presence of a communicable disease.
  • Teeth to be measured with restorations, caries, excessive wear, or structural defects that could affect measurement.
  • Active orthodontic treatment.
  • Developmental or structural anomalies affecting enamel and potentially increasing susceptibility to extrinsic staining, including hypomineralization, amelogenesis imperfecta, or dentinogenesis imperfecta.
  • Severe dental crowding preventing standardized measurements.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

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: Sequence A: Right GBT / Left Conventional Polishing
Participants assigned to Sequence A received Guided Biofilm Therapy on the right half of the mouth and conventional polishing on the left half of the mouth. Both interventions were performed within the split-mouth study design.
Procédure: Guided Biofilm Therapy
Dental biofilm was first disclosed to guide treatment. Supragingival biofilm and extrinsic staining were then removed using an air-water-powder system with a low-abrasive erythritol-based powder. Supragingival ultrasonic instrumentation was performed where necessary, followed by final surface control.
Autres noms:
  • GBT
Procédure: Conventional Polishing
Supragingival instrumentation was performed as needed, followed by mechanical polishing with a prophylaxis brush and polishing paste at 2500 to 3000 rpm. The procedure was completed with final surface control.
Autres noms:
  • CONV
Expérimental: Sequence B: Right Conventional Polishing / Left GBT
Participants assigned to Sequence B received conventional polishing on the right half of the mouth and Guided Biofilm Therapy on the left half of the mouth. Both interventions were performed within the split-mouth study design.
Procédure: Guided Biofilm Therapy
Dental biofilm was first disclosed to guide treatment. Supragingival biofilm and extrinsic staining were then removed using an air-water-powder system with a low-abrasive erythritol-based powder. Supragingival ultrasonic instrumentation was performed where necessary, followed by final surface control.
Autres noms:
  • GBT
Procédure: Conventional Polishing
Supragingival instrumentation was performed as needed, followed by mechanical polishing with a prophylaxis brush and polishing paste at 2500 to 3000 rpm. The procedure was completed with final surface control.
Autres noms:
  • CONV

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change in Tooth Color From Immediately After Treatment to 2 Months Assessed by CIELAB ΔE*ab Using a SpectroShade Micro Spectrophotometer
Délai: Immediately after treatment (Day 1) and at 2 months
Tooth color was measured using a SpectroShade Micro spectrophotometer according to the CIELAB color system. Color change between immediately after treatment (T0) and 2 months (T2) was calculated as ΔEab using the formula: ΔEab = [(ΔL*)² + (Δa*)² + (Δb*)²]^(1/2). ΔEab is a continuous color-difference measure, with 0 indicating no color difference and higher values indicating greater color change. Therefore, lower ΔEab values indicate greater color stability.
Immediately after treatment (Day 1) and at 2 months

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Change in Tooth Color From Immediately After Treatment to 1 Month Assessed by CIELAB ΔE*ab Using a SpectroShade Micro Spectrophotometer
Délai: Immediately after treatment (Day 1) and at 1 month
Tooth color was measured using a SpectroShade Micro spectrophotometer according to the CIELAB color system. Color change between immediately after treatment (T0) and 1 month (T1) was calculated as ΔEab using the formula: ΔEab = [(ΔL*)² + (Δa*)² + (Δb*)²]^(1/2). ΔEab is a continuous color-difference measure, with 0 indicating no color difference and higher values indicating greater color change. Therefore, lower ΔEab values indicate greater color stability.
Immediately after treatment (Day 1) and at 1 month
Change in Tooth Color From 1 Month to 2 Months
Délai: At 1 month and 2 months
Tooth color was measured using a SpectroShade Micro spectrophotometer according to the CIELAB color system. Color change between 1 month (M1) and 2 months (M2) was calculated as ΔE*ab using the formula: ΔE*ab = [(ΔL*)² + (Δa*)² + (Δb*)²]^(1/2). Lower ΔE*ab values indicate less color change.
At 1 month and 2 months
Patient-Reported Discomfort Assessed Using a 10-cm Visual Analog Scale
Délai: Immediately after completion of each half-mouth intervention (Day 1)
Patient-reported discomfort was assessed immediately after each half-mouth procedure using a 10-cm visual analog scale ranging from 0 to 10, where 0 indicated no discomfort and 10 indicated unbearable discomfort. The score reflected the overall perception of pain or sensitivity, heat, pressure or vibration, and discomfort related to water spray or aerosol. Lower scores indicate greater patient comfort.
Immediately after completion of each half-mouth intervention (Day 1)
Total Procedure Time Measured Using a Digital Stopwatch
Délai: Periprocedural
Total procedure time for each intervention was recorded using a digital stopwatch. Timing began with the first clinical step of the relevant intervention and ended after completion of the final surface check. Patient preparation, isolation, and oral hygiene instruction were excluded. Procedure time was recorded in minutes and seconds, with shorter times indicating greater procedural efficiency.
Periprocedural

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Ataturk University

Les enquêteurs

  • Directeur d'études: Recep Orbak, DDS, PhD, Ataturk University

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

5 janvier 2026

Achèvement primaire (Réel)

1 juin 2026

Achèvement de l'étude (Réel)

8 juin 2026

Dates d'inscription aux études

Première soumission

18 août 2026

Première soumission répondant aux critères de contrôle qualité

28 août 2026

Première publication (Réel)

2 septembre 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

2 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

28 août 2026

Dernière vérification

1 août 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 926

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

De-identified individual participant data underlying the results reported in the published article will be shared. These data may include participant-level demographic variables, treatment allocation, ΔE*ab color-change outcomes, visual analog scale scores, and procedure-time data necessary to reproduce the reported analyses.

Délai de partage IPD

Data and supporting information will be available beginning 6 months after publication of the study results and will remain available for 5 years.

Critères d'accès au partage IPD

Qualified researchers may request access from the corresponding author for scientifically justified research purposes. Requests should include a brief research proposal describing the purpose of the analysis and the data requested. Access will be considered following review of the proposed use and applicable ethical and confidentiality requirements. Only de-identified data relevant to the approved request will be shared electronically.

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

produit fabriqué et exporté des États-Unis.

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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