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Impacto do Condicionamento da Superfície Radicular com Polimento a Ar com Eritritol e Instrumentação Manual na Cobertura de Recessão Utilizando a Técnica do Túnel Modificada e Enxerto de Tecido Conjuntivo Subepitelial.

1 de outubro de 2026 atualizado por: Medical University of Warsaw

Impacto do Condicionamento da Superfície Radicular com Polimento a Ar de Eritritol versus Instrumentação Manual na Cobertura de Recessões Utilizando a Técnica de Túnel Modificada e Enxerto de Tecido Conjuntivo Subepitelial: Um Ensaio Clínico Randomizado

This study aims to evaluate whether the method of root surface preparation influences surgical outcomes. It will assess whether manual root instrumentation can be replaced by a less invasive erythritol air-polishing technique.

Visão geral do estudo

Tipo de estudo

Intervencional

Inscrição (Estimado)

20

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.

Contato de estudo

  • Nome: Magdalena Latkowska - Wiśniewska
  • Número de telefone: +48691470290
  • E-mail: magda.latko@gmail.com

Estude backup de contato

Locais de estudo

    • Mazowsze
      • Warsaw, Mazowsze, Polônia, 00-246
        • Recrutamento
        • Department of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw, Warsaw

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

18 anos a 60 anos (Adulto)

Aceita Voluntários Saudáveis

Sim

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • Multiple RT1 and/or RT2 gingival recessions, symmetrical and bilateral, with a minimum height of ≥ 1 mm
  • Full-mouth plaque score (FMPS) < 15% (assessed on four surfaces per tooth)
  • Full-mouth bleeding on probing (FMBOP) < 15% (assessed on four surfaces per tooth)
  • Detectable cemento-enamel junction (CEJ)
  • Age ≥ 18 years

Exclusion Criteria:

  • RT3 gingival recessions
  • Gingival recessions affecting second and third molars
  • Systemic or infectious diseases that may impair wound healing, including active malignancy, diabetes mellitus with HbA1c > 7.0%, history of head and neck radiotherapy, true xerostomia, and HIV/AIDS
  • Cervical caries, non-carious cervical lesions, or Class V restorations interfering with the CEJ
  • Active periodontitis
  • Use of medications affecting periodontal tissues or wound healing, including systemic corticosteroids, immunosuppressants, isotretinoin, bisphosphonates, and monoclonal antibodies with immunosuppressive, antiresorptive, or antiangiogenic effects
  • Smoking
  • Pregnancy or breastfeeding

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: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Dobro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Erythritol Air-Polishing

Sites with gingival recessions treated with root surface preparation using erythritol air-polishing prior to modified tunnel technique with subepithelial connective tissue graft.

Root surface preparation performed using erythritol powder air-polishing (EMS AIRFLOW PLUS) prior to root coverage surgery with a modified tunnel technique and subepithelial connective tissue graft.

Comparador Ativo: Manual Root Instrumentation

Sites with gingival recessions treated with root surface preparation using manual Gracey curettes prior to modified tunnel technique with subepithelial connective tissue graft.

Mechanical root surface preparation performed using manual Gracey curettes before root coverage surgery with a modified tunnel technique and subepithelial connective tissue graft.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Mean Root Coverage (MRC, %)
Prazo: 6 months and 12 months post-surgery

Mean root coverage (MRC), expressed as a percentage (%), assessed at 6 and 12 months post-surgery.

MRC is calculated as (GR₀ - GR₆) / GR₀ × 100% and (GR₀ - GR₁₂) / GR₀ × 100%, respectively.

Gingival recession (GR), measured in millimeters (mm) as the distance from the cemento-enamel junction (CEJ) to the gingival margin at the mid-buccal aspect of the tooth, is used solely as an input parameter for the calculation of MRC.

6 months and 12 months post-surgery

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Gingival recession height (GRH, mm)
Prazo: baseline, 6 months, and 12 months post-surgery

Distance from the cemento-enamel junction (CEJ) to the gingival margin measured at the mid-buccal aspect of the tooth.

baseline, 6 months, and 12 months post-surgery
Gingival recession width (RW, mm)
Prazo: baseline, 6 months, and 12 months post-surgery

Horizontal distance measured at the level of the cemento-enamel junction (CEJ) between the mesial and distal margins of the gingival recession.

baseline, 6 months, and 12 months post-surgery
Clinical Attachment Level (CAL, mm)
Prazo: Baseline; 6 and 12 months post-surgery

Distance from the cemento-enamel junction (CEJ) to the bottom of the gingival sulcus.

Baseline; 6 and 12 months post-surgery
Probing Pocket Depth (PPD, mm)
Prazo: baseline, 6 months, and 12 months post-surgery

Distance from the gingival margin to the bottom of the gingival sulcus.

baseline, 6 months, and 12 months post-surgery
Gingival Thickness (GT, mm)
Prazo: baseline, 6 months, and 12 months post-surgery

Thickness of the gingiva measured 3 mm apical to the gingival margin at the mid-buccal aspect of the tooth.

baseline, 6 months, and 12 months post-surgery
Keratinized tissue width (KTW, mm)
Prazo: baseline, 6 months, and 12 months post-surgery

Distance from the gingival margin to the mucogingival junction

baseline, 6 months, and 12 months post-surgery
Complete Root Coverage (CRC, %)
Prazo: 6 months and 12 months post-surgery

% CRC = (number of teeth with CRC = 1 after treatment / total number of teeth with gingival recession at baseline) × 100.

CRC = 1: postoperative GR ≤ 0 mm, indicating complete root coverage. CRC = 0: postoperative GR > 0 mm, indicating partial or no root coverage.

6 months and 12 months post-surgery
Gingival Recession Reduction (GR red, mm)
Prazo: 6 months and 12 months post-surgery

Reduction in recession height at 6 months: GR₀ - GR₆ Reduction in recession height at 12 months: GR₀ - GR₁₂

6 months and 12 months post-surgery
Clinical Attachment Level Gain (CAL Gain, mm)
Prazo: 6 months and 12 months post-surgery

Clinical attachment level gain at 6 months = CAL₀ - CAL₆

Clinical attachment level gain at 12 months = CAL₀ - CAL₁₂

6 months and 12 months post-surgery
Keratinized Tissue Width Gain (KTW Gain, mm)
Prazo: 6 months and 12 months post-surgery

Increase in keratinized tissue width at 6 months: KTW₆ - KTW₀ Increase in keratinized tissue width at 12 months: KTW₁₂ - KTW₀

6 months and 12 months post-surgery
Tooth Sensitivity (SEN, Schiff score)
Prazo: Assessed on the day of surgery before administration of anesthesia, and subsequently at 6 and 12 months after surgery.

Clinician-assessed tooth sensitivity evaluated using the Schiff Cold Air Sensitivity Scale.

Air will be delivered using a standard air syringe of the dental unit, positioned approximately 1 cm from the tooth surface for 5 seconds, at a working temperature of 23 °C (±4 °C), and directed at the exposed buccal surface of the tooth with gingival recession.

Patient response to the air stimulus will be assessed by the clinician using the Schiff Cold Air Sensitivity Scale as follows:

0 = No response to the air stimulus

  1. = Response to the air stimulus, but no request to discontinue the stimulus
  2. = Response to the air stimulus, with a request to discontinue the stimulus and/or turning away from the stimulus
  3. = Painful response to the air stimulus, with a request to discontinue the stimulus
Assessed on the day of surgery before administration of anesthesia, and subsequently at 6 and 12 months after surgery.
Root Esthetic Score (RES, score)
Prazo: 6 and 12 months after surgery

Root Esthetic Score (RES), expressed as a composite score ranging from 0 to 10 points.

The RES is a clinician-assessed composite esthetic outcome comprising the following five components:

  1. Gingival Margin (GM): failure of root coverage (0 points), partial root coverage (3 points), complete root coverage (6 points);
  2. Marginal Tissue Contour (MTC): irregular gingival margin not following the cemento-enamel junction (CEJ) (0 points), scalloped gingival contour following the CEJ (1 point);
  3. Soft Tissue Texture (STT): presence of scar (0 points), absence of scars (1 point);
  4. Mucogingival Junction (MGJ): MGJ not aligned with the MGJ of adjacent teeth (0 points), MGJ aligned with the MGJ of adjacent teeth (1 point);
  5. Gingival Color (GC): color mismatch with adjacent teeth (0 points), color matching adjacent teeth (1 point).

The total RES score is calculated as the sum of all component scores, with higher scores indicating a better esthetic outcome.

6 and 12 months after surgery
Discomfort during the procedure (VAS, 0-10)
Prazo: Immediately after completion of the procedure

Patient-reported discomfort during the procedure assessed using the Visual Analogue Scale (VAS; 0 = no discomfort, 10 = extreme discomfort).

Immediately after completion of the procedure
Pain intensity (VAS scale, 0-10)
Prazo: 1, 2, 4, 7, 14 days after procedure

Patient-reported pain intensity assessed using the Visual Analogue Scale (VAS; 0 = no pain, 10 = maximum pain).

1, 2, 4, 7, 14 days after procedure
Postoperative swelling (VAS scale, 0-10)
Prazo: 1, 2, 4, 7, 14 days after procedure

Patient-reported swelling assessed using the Visual Analogue Scale (VAS; 0 = none, 10 = maximum).

1, 2, 4, 7, 14 days after procedure
Tooth sensitivity (VAS, 0-10)
Prazo: 1, 2, 4, 7, and 14 days post-procedure

Patient-reported tooth sensitivity assessed using the Visual Analogue Scale (VAS; 0 = none, 10 = maximum).

1, 2, 4, 7, and 14 days post-procedure
Gingival color (VAS, 0-10)
Prazo: 6 and 12 months post-surgery

Patient-reported gingival color assessed using the Visual Analogue Scale (VAS; 0 = very poor, 10 = excellent).

6 and 12 months post-surgery
Gingival shape (VAS 0-10)
Prazo: 6 and 12 months post-surgery

Patient-reported gingival shape assessed using a single Visual Analogue Scale (VAS; 0 = very poor, 10 = excellent)

6 and 12 months post-surgery
Tooth appearance (VAS, 0-10)
Prazo: 6 and 12 months post-surgery

Patient-reported tooth appearance assessed using the Visual Analogue Scale (VAS; 0 = very poor, 10 = excellent).

6 and 12 months post-surgery

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Procedure-related stress (VAS, 0-10)
Prazo: Baseline (day of surgery, pre-anesthesia)

Patient-reported procedure-related stress assessed using the Visual Analogue Scale (VAS; 0 = no stress, 10 = extreme stress).

Baseline (day of surgery, pre-anesthesia)
Treatment satisfaction (VAS, 0-10)
Prazo: 12 months after surgery

Patient-reported treatment satisfaction assessed using the Visual Analogue Scale (VAS; 0 = not satisfied at all, 10 = completely satisfied).

12 months after surgery
Willingness to choose the treatment again (yes/no)
Prazo: 12 months after surgery

Patient-reported willingness to choose the same treatment again assessed using a dichotomous (yes/no) question.

12 months after surgery
Willingness to recommend the treatment (yes/no)
Prazo: 12 months after surgery

Patient-reported willingness to recommend the treatment to others assessed using a dichotomous (yes/no) question.

12 months after surgery

Colaboradores e Investigadores

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

Investigadores

  • Cadeira de estudo: Bartłomiej Górski, Department of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw, Warsaw

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)

9 de março de 2026

Conclusão Primária (Estimado)

1 de junho de 2027

Conclusão do estudo (Estimado)

1 de julho de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

21 de janeiro de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

3 de fevereiro de 2026

Primeira postagem (Real)

11 de fevereiro de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

2 de outubro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

1 de outubro de 2026

Última verificação

1 de setembro de 2026

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • WUM.Perio.06

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

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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