- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07403006
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.
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
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Magdalena Latkowska - Wiśniewska
- Número de telefone: +48691470290
- E-mail: magda.latko@gmail.com
Estude backup de contato
- Nome: Bartłomiej Górski
- E-mail: gorskibartlomiej04@gmail.com
Locais de estudo
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Mazowsze
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Warsaw, Mazowsze, Polônia, 00-246
- Recrutamento
- Department of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw, Warsaw
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
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
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
|
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:
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
Patrocinador
Investigadores
- Cadeira de estudo: Bartłomiej Górski, Department of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw, Warsaw
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- WUM.Perio.06
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