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Activo, sin reclutamientoNCT04179448Registro de ClinicalTrials.gov

A Comparison of Side Access Mucosal Releasing Incision (SAMRI) and Sulcular Tunnel Access to Treat Gingival Recession.

Gingival Recession · Lack of Keratinized Gingiva

LO ESENCIAL

De qué trata este estudio

El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.

Tipo de estudio
De intervención
Fase
No aplica
Rango de edad
18 años - 99 años
Sexo admitido
Todos los sexos
Voluntarios sanos
Aceptados
Participantes
22 Real

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Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.

Acerca de la investigación

This study will compare two incision designs to allow for coronal gingival/mucosal flap advancement and tissue augmentation with acellular dermal matrix (ADM) graft around teeth with gingival recession and a lack of adequate keratinized gingiva.

The SAMRI technique described is a novel technique involving a simplified incision and suturing technique and to the investigators' knowledge, this is the first study that seeks to compare this technique to other techniques for differences in clinical outcomes (percentage root coverage, resultant tissue thickness, and width of keratinized tissue) and patient-centered outcomes (post-operative pain, swelling, changes in daily activities, and patient-assessed esthetics) in a controlled study.

Leer la descripción completa

Research data and daily clinical observations reveal that teeth with gingival recession and a lack of adequate keratinized tissue (KT) are more prone to persistent gingival inflammation, dentinal sensitivity, radicular (root) caries (tooth decay), faster periodontal attachment loss, and compromised plaque control. Soft tissue grating (by various techniques) aims at changing the quality, quantity and placement of the soft tissue around teeth by covering exposed root surfaces and creating or increasing the zone of keratinized mucosa (KM) surrounding the affected teeth. Both techniques tested have shown good clinical outcomes with regard to root coverage, but clinical reports suggest that decreased intrasurgical time and the simplified protocol of the SAMRI technique may result in improved clinical outcomes and/or a decrease in postoperative morbidity and complications as assessed by patients.

Specific aims for this project include the evaluation of:

  • Percentage of root coverage at 6 and 12 months following grafting with SAMRI and sulcular tunnel access with ADM
  • KT width at 6 and 12 month following grafting with SAMRI and sulcular tunnel access with ADM
  • Change in tissue thickness of the grafted sites at 6 and 12 months
  • Practitioner-assessed esthetic outcomes using a standardized pink esthetic scale (PES) at 6 and 12 months postoperatively
  • Patient-assessed esthetic outcomes at 6 and 12 months post-operatively
  • Patient centered outcomes including pain, bleeding, swelling, change in daily activities at 1 week and 1 month postoperatively

¿Quién podría participar?

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Inclusion Criteria:

  • English speaking
  • At least 18 years old
  • Must be a patient of the UAB Dental School
  • Able to read and understand informed consent document
  • One or more adjacent teeth (up to four) with Miller class I or II gingival recession defects and less than or equal to 2mm of KT at each site to be treated.
  • Presence of periodontally healthy, non-carious neighboring teeth, healthy implants or edentulous ridges on either side of the involved site(s)
  • No anticipated need for restorative care at the teeth to be treated during the study period.

Exclusion Criteria:

  • Non-English speaking
  • Less than 18 years old
  • Smokers/tobacco users (\>10 cigarettes/day)
  • Patients with systemic pathologies or conditions contraindicating oral surgical procedures or adversely affecting wound healing
  • Presence of active periodontal disease or radiographic interproximal bone loss or tooth malposition, which would yield a Miller class III or IV categorization for the recession defect.
  • Presence of frenulae or other soft tissue anomalies at the site(s) to be treated that, in the opinion of the investigators, will interfere with successful access and treatment of the soft tissue defects.
  • Previous soft tissue grafting at the site(s) to be treated
Entiende la evaluación inicial

Tratamiento, grupos y participación

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Asignación
Asignación al azar
Enmascaramiento
Enmascaramiento simple
Side Access Mucosal Releasing Incision (SAMRI)

SAMRI incision to allow for coronally advanced flap and placement of acellular dermal matrix (ADM) graft

Procedure: SAMRI

Sulcular Tunnell access

Sulcular tunnel access incision to allow for coronally advanced flap and placement of acellular dermal matrix (ADM) graft

Procedure: STA

SAMRI PROCEDURE

Side Access Mucosal Releasing Incision (SAMRI) will be performed on all individuals in this arm of the study to facilitate coronal advancement of the gingival flap and placement of acellular dermal matrix

STA PROCEDURE

Sulcular tunnel access incision will be performed on all individuals in this arm of the study to facilitate coronal advancement of the gingival flap and placement of acellular dermal matrix

Prepara tus preguntas

Qué evalúan los investigadores

Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.

Medidas principales

Percentage of root coverage at 6 and 12 months following grafting with SAMRI and sulcular tunnel access with ADM

Plazo: From baseline to 6 months and 12 months

Compare the change in the exposed root surface at sites with gingival recession.

Medidas secundarias

KT width at 6 and 12 month following grafting with SAMRI and sulcular tunnel access with ADM

Plazo: From baseline to 6 and 12 months

Compare the change in keratinized tissue (KT) between two incision designs for root coverage and tissue augmentation.

Change in tissue thickness of the grafted sites at 6 and 12 months

Plazo: From baseline to 6 and 12 months

Using a periodontal probe, soft tissue thickness will be measured (in mm) and compared between FGG and CTG following soft tissue grafting.

Assessed esthetic outcomes using a standardized pink esthetic scale (PES) at 6 and 12 months postoperatively

Plazo: From baseline to 6 and 12 months

Assess esthetic outcomes using an established periodontal esthetic score (PES). This score evaluates the color of the gum utilizing 5 subscales ranging from 0(worse) to 2 (better) allowing for a summed total score of 10.

Assessed esthetic outcomes at 6 and 12 months post-operatively

Plazo: At 6 and 12 months postoperatively

A visual analogue scale (VAS) based questionnaire regarding esthetic appearance, pain, swelling, bruising, effects on daily activities will be administered. This measurement ranges from 0-10 (0 being better and 10 being worse).

Patient centered outcomes including pain, bleeding, swelling, change in daily activities at 1 week and 1 month postoperatively

Plazo: 1 week, 2 weeks, 1 month, 3 months, 6 months and 12 months postoperatively.

A visual analogue scale (VAS) based questionnaire regarding esthetic appearance, pain, swelling, bruising, effects on daily activities. This measurement ranges from 0-10 (0 being better and 10 being worse).

El registro no indica resultados publicados.

Revisa las tablas completas y sus limitaciones en el registro oficial.

Abrir resultados oficiales ↗

Centros de investigación (1)

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1 centros

University of Alabama at BirminghamBirmingham, Alabama, United StatesEstado desconocido

Equipo y fechas

Patrocinador principal
University of Alabama at Birmingham
Inicio del estudio
11 feb 2021 Real
Finalización primaria
11 dic 2023 Real
Finalización del estudio
2027-08 Estimado
Primera publicación
27 nov 2019 Real
Última actualización
10 nov 2026 Real

Contactos oficiales del estudio

No hay un contacto central indicado. Revisa los centros y el registro oficial.

Título oficial del estudio

A Prospective, Randomized Clinical Trial to Compare Side Access Mucosal Releasing Incision (SAMRI) and Sulcular Tunnel Access Procedures With Coronally Advanced Flap and Acellular Dermal Matrix (ADM) to Treat Gingival Recession.

EL PRÓXIMO PASO, CON APOYO HUMANO

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Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.

Consultado: 12 nov 2026 · Última actualización del registro: 10 nov 2026