Mechanical-chemical Gingival Therapy in Diabetics and/or Obese (MCGTDO)
23 de abril de 2014 actualizado por: University of Taubate
Evaluation of Mechanical-chemical Gingival Therapy in Diabetic, Obese or Diabese Subjects: Quantitative and Qualitative Analysis of Local and General Aspects.
Diabetes and obesity affect many people in different countries.
Similarly, millions of people have some type of gum disease such as gingivitis.
The present study was conducted to clarify if systemic conditions such as diabetes and obesity could impair the response to gingivitis treatment.
Subjects with gum disease showing diabetes type II (from 40 to 50 subjects), slight to moderate obesity (from 40 to 50 subjects) or its combination (from 40 to 50 subjects) were selected for the present study.
In addition normal-weight subjects with gum disease (from 40 to 50 subjects) besides a group without gum disease (from 40 to 50 subjects) were selected for comparisons.
After verbal and written explanations about the study, subjects who matched study criteria and who signed the informed consent form underwent full oral examinations in two separate visits.
In the first visit, after a clinical examination to verify the levels of gingival inflammation and the accumulated amounts of dental plaque, the bone height was determined by X-Ray examinations.
Bad breath was also evaluated by a chair-side apparatus.
Additional laboratorial examinations included a) quantification of bacteria that cause gum disease from dental plaque samples, b) quantification of inflammatory products from gingival fluid sampling and c) quantification of produced saliva.
Self-report questionnaires were used to check the impact of oral condition and treatment of gum disease in quality of life and individual daily performance.
These examinations were repeated 3 months after dental treatment.
All subjects received ultrasonic dental prophylaxis for cleaning their teeth.
Based on systemic/oral conditions each group rinsed either an essential-oils containing mouth rinse or a placebo rinse.
First rinse was supervised and the other ones were performed at home twice a day for three months.
Each participant also received a toothbrush, a dental floss and a fluoride toothpaste monthly after oral hygiene instructions.
Adherence to the treatment and occurrence of undesirable side effects were monitored throughout the study.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
240
Fase
- Fase 4
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
SP
-
Taubate, SP, Brasil, 12020330
- University of Taubate - Nucleus of periodontal research
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 45 años (Adulto)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- plaque-related gingivitis (with no radiographic evidence of periodontal bone resorption and a bleeding site rate of more than 30%)
- periodontally healthy group (with no radiographic evidence of periodontal bone resorption and a bleeding site rate of less than 30%)
- at least 20 natural teeth
- diabetes group: controlled type II diabetes (with a blood glycated hemoglobin level between 6.5 and 7%) that was diagnosed at least 3 years but no more than 5 years prior to the study
- normal salivary flow
- obesity group: obesity level I - body mass index: 30 to 34.99 kg/m2 or obesity level II - body mass index: 35 to 39.99 kg/m2
- normal weight group: body mass index: 20 to 24.99 kg/m2;
Exclusion Criteria:
- gingival overgrowth
- orthodontic devices
- extended prosthetic fixed devices
- removable partial dentures or overhanging restorations
- systemic diseases or other conditions that could influence the periodontal status (other than diabetes within the diabetic group)
- overweight - BMI 25 to 29.99 kg/m2 and obesity level III or morbid obesity - ≥ 40 kg/m2 (obesity group) - alcohol abuse
- pregnancy or breast-feeding
- history of sensitivity or suspected allergies following the use of oral hygiene products
- the need for antibiotic prophylaxis; antibiotics and/or anti-inflammatory drug use in the six months prior to the beginning of the study
- regular use of chemotherapeutic antiplaque/antigingivitis products
- periodontal treatment performed within six months prior to study initiation
- unwillingness to return for follow-up
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Ultrason Essential oils rinse
Ultrasonic debridement followed by twice daily home use of an essential-oils mouth rinse (20mL, 30 seconds for each rinse) for 3 months
|
Test treatment strategy combined mechanical and chemical procedures.
Mechanical procedures were: a) ultrasonic debridement to remove dental plaque, calculus and teeth staining; b) dental polishing and c) oral hygiene instructions related to brushing and flossing.
Toothbrush, dental floss and fluoride dentifrice were monthly provided.
Within the same visit participants performed at the study center the first supervised rinse.
Other rinses were performed at home unsupervised.
A diary card was used to register times of rinsing.
Participants rinsed twice a day a commercially available non-prescription essential-oils solution (20mL, 30 seconds for each rinse) for 3 months.
This solution is composed of eucalyptol 0.092%, menthol 0.042%, methyl salicylate 0.060%, thymol 0.064%, zinc chloride and sodium fluoride 0.0221%.
Otros nombres:
|
|
Comparador de placebos: Ultrason Placebo rinse
Ultrasonic debridement followed by twice daily home use of a placebo rinse (20mL, 30 seconds for each rinse) for 3 months
|
Comparative treatment strategy combined mechanical and chemical procedures.
Mechanical procedures were: a) ultrasonic debridement to remove dental plaque, calculus and teeth staining; b) dental polishing and c) oral hygiene instructions related to brushing and flossing.
Toothbrush, dental floss and fluoride dentifrice were monthly provided.
Within the same visit participants performed at the study center the first supervised rinse.
Other rinses were performed at home unsupervised.
A diary card was used to register times of rinsing.
Participants rinsed twice a day a placebo solution (20mL, 30 seconds for each rinse) for 3 months.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
plaque and gingival indices
Periodo de tiempo: 3 months
|
percentage of dental surfaces showing mild (scores 0,1), moderate (scores 2,3) or severe (scores 4,5) amounts of dental plaque or showing gingival bleeding (positive or negative) after gentle probing
|
3 months
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de junio de 2012
Finalización primaria (Actual)
1 de junio de 2013
Finalización del estudio (Actual)
1 de septiembre de 2013
Fechas de registro del estudio
Enviado por primera vez
9 de abril de 2014
Primero enviado que cumplió con los criterios de control de calidad
23 de abril de 2014
Publicado por primera vez (Estimar)
25 de abril de 2014
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
25 de abril de 2014
Última actualización enviada que cumplió con los criterios de control de calidad
23 de abril de 2014
Última verificación
1 de abril de 2014
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2010/20424-1
- 522/10 (Otro identificador: Ethics Committee Approval)
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .