- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07576439
Influence of Keratinized Tissue Width and Attached Gingiva Width on Root Coverage in Patients With Recession Defects: A Prospective Clinical Study
To evaluate the association between the width of keratinized tissue and attached gingiva with root coverage outcomes in RT1 gingival recession defects of maxillary and mandibular anterior teeth treated with subepithelial connective tissue graft (CTG) using a minimally invasive technique : modified vestibular incision subperiosteal tunnel access(m-VISTA).
OBJECTIVES
PRIMARY OBJECTIVES
- To analyze relation and association at 3 and 6 months outcomes in terms of CRC, mRC and gingival margin position with baseline parameters including width of keratinized tissue and width of attached gingiva, after providing mucogingival plastic surgery in the form of m-VISTA+CTG for the treatment of RT1recession defects.
- To evaluate 3 and 6 months outcomes (percentage of root coverage, width of keratinized tissue and width of attached gingiva), after providing mucogingival plastic surgery in the form of m-VISTA+CTG for the treatment of RT1recession defects.
- To access the long-term stability of gingival margin achieved from 3 months to 6 months.
SECONDARY OBJECTIVES
- To access recession depth (RD), recession width (RW), probing pocket depth (PPD), mid buccal clinical attachment loss (bCAL), change in gingival thickness (GT) at baseline, at 3 months and 6 months.
- To access patient related outcomes measures (PROM) in pain and hypersensitivity in teeth with gingival recession undergoing recession coverage.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Recent longitudinal evidence suggests that soft tissue thickness may play a more decisive role in long-term stability than keratinized tissue width (KTW) alone. The baseline keratinized tissue width necessary to achieve stable outcomes remain lacking as the scarcity of cases presenting with minimal or no keratinized tissue width limited the exploration of its influence on achieving complete root coverage in scenarios characterized by extremely reduced or absent keratinized tissue width.
Furthermore, attached gingiva width (AGW) has been insufficiently studied despite its proposed biological relevance in providing functional connective tissue attachment to the underlying hard tissues. In recent randomized controlled trial attached gingiva width was considered along with root coverage percentage as a primary outcome in evaluating collagen matrix (CM) versus connective tissue graft with modified coronally advanced tunnel technique in isolated RT1 cases. A recent study in which anatomical factors affecting root coverage among mandibular incisors were studied and presented limitations such as restricted inclusion of sites, presenting type of recession defects and limited cases with minimal or absent keratinized tissue, thereby limiting its ability to define its absolute indication or minimum requirement for successful root coverage. Collectively, these limitations were particularly related to inclusion of mandibular sites. On perusal of literature revealed there is no prospective study in which baseline keratinized tissue width and attached gingiva width as prognostic factors for root coverage were studied.
Therefore, the aim of this prospective clinical study is to determine if anatomical factors such as keratinized tissue width and attached gingiva width influence recession defects coverage of RT1 recession treated with minimally invasive surgical technique along with connective tissue graft.
Details of Methodology
- Study design and setting The present clinical trial will be conducted in the department of Periodontics, Post Graduate Institute of Dental Sciences, Rohtak, Haryana.
- Study period- up to 24 months
- Study subjects The sample size was calculated using G*Power software to achieve 80% statistical power for detecting a significant correlation of r = 0.5 using a linear regression model based on the previously conducted prospective study. The analysis indicated that 26 patients were required. To compensate for an anticipated 10% dropout rate, the sample size was increased, resulting in a final required sample size of 30 participants.
e. Method of recruitment The study will recruit systematically healthy patients exhibiting Millers class Ⅰ and Ⅱ or RT1 recession defects in maxillary and mandibular anterior teeth from the periodontology outpatient department.
f. Intervention Scaling and root planing Following selection, all the patients will be subjected to phase I therapy, which included full mouth scaling and root planing using ultrasonic scalers and hand instrumentation.
Surgical procedure Connective Tissue Graft Harvesting (Single Incision Technique) After local anesthesia, a single horizontal incision was made 2 mm from the gingival margin of maxillary premolars using a #15 blade (90° to bone). A partial thickness dissection was performed through the same incision to create an undermined area of required size. The connective tissue graft was then outlined with mesial, distal, and medial incisions, separated, and removed using a periosteal elevator. The donor site was closed with horizontal suspension sutures.
m-VISTA Technique : After local anesthesia and root planing, a small vestibular incision was made near the MGJ using a 15C blade. A full-thickness subperiosteal tunnel was created and extended beneath adjacent papillae. An SCTG was inserted through the incision, positioned under the recession area, and the gingivo-papillary complex was coronally advanced and secured with monofilament sutures.
Post operative care Suitable antibiotics and analgesics will be prescribed for 5 days. Chlorhexidine (0.12%) mouthwash for a week. The Coronally attached bonded sutures will be removed after 3 weeks.
Follow up All patients will be recalled for recording of all the clinical parameters at 3and 6 months.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Shikha Tewari, MDS
- Número de teléfono: +919416514600
- Correo electrónico: drshikhatewari@yahoo.com
Copia de seguridad de contactos de estudio
- Nombre: Tewari
- Correo electrónico: richatirkey16@gmail.com
Ubicaciones de estudio
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Haryana
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Rohtak, Haryana, India, 124001
- Reclutamiento
- Post Graduate Institute of Dental Sciences
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Contacto:
- Shikha Tewari, MDS
- Número de teléfono: +919416514600
- Correo electrónico: drshikhatewari@yahoo.com
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Contacto:
- Richa Tirkey, BDS
- Número de teléfono: +918210892921
- Correo electrónico: richatirkey16@gmail.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Patients with Millers class Ⅰ and II / RT1 isolated recession defects in labial maxillary and mandibular anterior teeth region.
- Recession depth ≥2mm
- Systemically healthy individuals.
- Age >18 years old.
- Full mouth bleeding and plaque score ≤20%
- Patients who agreed to participate in the study and signed an informed consent form.
Exclusion Criteria:
- Patients having systemic disease such as hypertension, diabetes, hyperthyroidism or on medication that influence the outcome of periodontal therapy.
- Patient with active periodontal disease
- Smokers and tobacco users
- Mal-aligned tooth with recession.
- Patients who had already undergone root coverage procedure on the selected site.
- Pregnant and lactating females
- Involved tooth with trauma from occlusion.
- Involved tooth with prosthesis.
- Endodontically involved/ RCT treated tooth
- Tooth with cervical abrasion / undetectable CEJ/ carious
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: treatment of RT1 gingival recession defects using m-VISTA with connective tissue graft
|
the aim of this prospective clinical study is to determine if anatomical factors such as keratinized tissue width and attached gingiva width influence recession defects coverage of RT1 recession treated with minimally invasive surgical technique along with connective tissue graft. Keratinized tissue width and attached gingiva width are considered important for maintaining gingival health and long-term stability after root coverage. However, there is limited and unclear evidence on how much keratinized or attached gingiva is actually needed for successful root coverage. Most previous studies have focused on soft tissue thickness rather than these parameters. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
root coverage
Periodo de tiempo: 6 months
|
root coverage will be calculated in percentage
|
6 months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Richa Tirkey, PGIDS Rohtak
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Dr. Richa Tirkey Periodontics
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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