Treatment of Advanced Periodontitis Using an Oscillating Chitosan Device Versus Regular Curettes Alone

Treatment of Advanced Periodontitis Using an Oscillating Chitosan Device Versus Regular Curettes Alone - a Randomized Parallel Arm Clinical Trial

Patrocinadores

Patrocinador principal: Labrida AS

Fuente Labrida AS
Resumen breve

40 patients diagnosed with localised periodontitis will be included at each center, 20 patients will be treated with the control treatment, 20 patients will be treated by test treatment.

Descripción detallada

2.3 This will be a prospective multicentre parallel arm randomized clinical trial of 6 months' duration. Clinical parameters of periodontal disease will be recorded at baseline and at 6 months. Radiographs will be taken at baseline and at 6 months.Treatment will be performed at baseline and thereafter every three months.

2.5 Study setting Patient screening, inclusions and all clinical examinations will be performed by a board-certified specialist in periodontology at the test centres. Treatment will be performed by a registered separate therapist, either dentist or dental hygienist.

2.7 Treatment allocation Patients will be allocated to one of the following treatments: control (curettes+ ultrasound scaler (USS) supra and subgingivally), test (curettes + USS supra and chitosan brush in oscillating handpiece subgingivally) by computer-generated block randomization to ensure equal sample sizes.

Estado general Recruiting
Fecha de inicio September 1, 2017
Fecha de Terminación February 28, 2020
Fecha de finalización primaria January 15, 2020
Fase N/A
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
Difference between groups in clinical signs of inflammation 6 months
Resultado secundario
Medida Periodo de tiempo
Difference between groups in clinical and radiographic attachment loss 6 months and 12 months
Inscripción 160
Condición
Intervención

Tipo de intervención: Device

Nombre de intervención: Labrida Bioclean

Descripción: The brush bristles of the test device (Labrida BioClean®, LABRIDA, Oslo, Norway) are made of the biopolymer chitosan

Etiqueta de grupo de brazo: Oscillating Chitosan Device

Otro nombre: Gracey Periodontal curettes

Tipo de intervención: Device

Nombre de intervención: Gracey Periodontal curettes

Descripción: Regular commercially available area specific and medical grade steel Gracey periodontal curettes

Etiqueta de grupo de brazo: Regular Curettes

Elegibilidad

Criterios:

Inclusion Criteria:

- 1. Periodontitis as previously defined on at least three teeth but less than 8 teeth.

2. Above 18 years of age.

3. Eligible for treatment in an outpatient dental clinic (ie, American Society of Anesthesiologist index (ASA) I and II).

4. Had full-mouth plaque scores ≤ 20% prior to final inclusion3 5. Signed Informed Consent obtained prior to start.

6. Psychological appropriateness 7. Consent to complete all follow-up visits

Exclusion Criteria:

1. Prosthetic constructions with technical complications which according to the examiners judgement has contributed to the disease state and not possible to resolve prior to final inclusion.

2. Receiving systemic antibiotics < 3 months prior to study start.

3. Pregnant or lactating.

4. Any condition or current treatment for any condition, which in the opinion of the investigator and/or consulting physician, may constitute an unwarranted risk.

5. Presence of psychological characteristics such as inappropriate attitude or motivation which, in the opinion of the investigator, are incompatible with the protocol.

6. Unwillingness to undergo treatment.

7. Ongoing or previous radiotherapy to the head-neck region.

8. Ongoing chemotherapy.

Género: All

Edad mínima: 18 Years

Edad máxima: 95 Years

Voluntarios Saludables: Accepts Healthy Volunteers

Oficial general
Apellido Papel Afiliación
Caspar Wohlfahrt Study Director Bjerke Tannmedisin
Contacto general

Apellido: Caspar Wohlfahrt, Dr.

Teléfono: 4790149330

Email: [email protected]

Ubicación
Instalaciones: Estado: Contacto: Copia de seguridad de contactos:
Bjerke tannmedisin | Oslo, 0286, Norway Recruiting Caspar Wohlfahrt, PhD 47905629 [email protected]
Colosseum Sola | Stavanger, Norway Recruiting Morten Klepp, Specialist +4751216800
Yeditetepe University; School of dentistry | Istanbul, Turkey Recruiting Bahar E Kuru, PhD [email protected]
Ubicacion Paises

Norway

Turkey

Fecha de verificación

November 2019

Fiesta responsable

Tipo: Principal Investigator

Afiliación del investigador: Labrida AS

Nombre completo del investigador: Caspar Wohlfahrt

Título del investigador: Specialist in periodontology

Tiene acceso ampliado No
Condición Examinar
Número de brazos 2
Grupo de brazo

Etiqueta: Oscillating Chitosan Device

Tipo: Experimental

Descripción: The brush bristles of the test device (Labrida BioClean®, LABRIDA AS, Oslo, Norway) are made of the biopolymer chitosan. Any debris left from the chitosan bristles is completely biocompatible and will dissolve or be resorbed, thus not causing harm to the tissues.surrounding the tooth. Chitosan is made from chitin derived from shell of marine crustaceans such as shrimp and crab, however chemically modified and thus not even considered to be animally derived. Chitosan has been approved for use in e.g., surgical bandages, as a haemostatic agent and as dietary supplement used in a wide range of nutritional and health products. Chitosan has also been documented to be non-allergenic and it has been suggested that chitosan has anti-inflammatory properties.

Etiqueta: Regular Curettes

Tipo: Active Comparator

Descripción: Standard non surgical treatment of active periodontal disease includes supra and subgingival scaling and root planing with periodontal medical grade Gracey system steel curettes

Datos del paciente No
Información de diseño del estudio

Asignación: Randomized

Modelo de intervención: Parallel Assignment

Propósito primario: Treatment

Enmascaramiento: Double (Investigator, Outcomes Assessor)

Descripción de enmascaramiento: Examiners blinded to treatment allocation

Fuente: ClinicalTrials.gov