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Guided Biofilm Therapy Versus Conventional Polishing for Tooth Re-Staining

28 de agosto de 2026 atualizado por: 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.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Real)

34

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Sim

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Prevenção
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição cruzada
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: 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.
Procedimento: 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.
Outros nomes:
  • GBT
Procedimento: 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.
Outros nomes:
  • CONV
Experimental: 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.
Procedimento: 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.
Outros nomes:
  • GBT
Procedimento: 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.
Outros nomes:
  • CONV

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change in Tooth Color From Immediately After Treatment to 2 Months Assessed by CIELAB ΔE*ab Using a SpectroShade Micro Spectrophotometer
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Change in Tooth Color From Immediately After Treatment to 1 Month Assessed by CIELAB ΔE*ab Using a SpectroShade Micro Spectrophotometer
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Ataturk University

Investigadores

  • Diretor de estudo: Recep Orbak, DDS, PhD, Ataturk University

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

5 de janeiro de 2026

Conclusão Primária (Real)

1 de junho de 2026

Conclusão do estudo (Real)

8 de junho de 2026

Datas de inscrição no estudo

Enviado pela primeira vez

18 de agosto de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

28 de agosto de 2026

Primeira postagem (Real)

2 de setembro de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

2 de setembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

28 de agosto de 2026

Última verificação

1 de agosto de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 926

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano 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.

Prazo de Compartilhamento de IPD

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

Critérios de acesso de compartilhamento 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.

Tipo de informação de suporte de compartilhamento de IPD

  • PROTOCOLO DE ESTUDO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

produto fabricado e exportado dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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