Influence of periodontal treatment in periodontitis and diabetes control

• Register: REBEC
• Last refreshed on: 29 April 2013
• Main ID: RBR-8dfrpt
• Date of registration: 01/02/2012
• Primary sponsor: Universidade Federal de Pernambuco - Brazil
• Public title: Influence of periodontal treatment in periodontitis and diabetes control
• Scientific title: Interaction between chronic periodontitis and type II diabetes: A randomized clinical trial to study the impact of periodontal treatment on severity of both pathologies by clinical, metabolic, immunology and microbiology parameters
• Date of first enrolment: 25/08/2011
• Target sample size: 150
• Recruitment status: recruiting
• URL: http://www.ensaiosclinicos.gov.br/rg/RBR-8dfrpt/
• Study design: Clinical trial controlled, randomized double-blind, with three arms

Countries of recruitment

Brazil

Contacts

• Name: Renata Cimões
• Affiliation: Universidade Federal de Pernambuco

• Name: Renata Cimões
• Affiliation: Universidade Federal de Pernambuco

Key inclusion & exclusion criteria

Inclusion criteria: Diagnosis of type 2 diabetes mellitus; aged 35 years old or more; at least 15 teeth present; clinical and radiographic diagnosis of the presence of chronic periodontitis (AAP, 1999); agreing to participate the study.
Exclusion criteria: Periodontal treatment over the past six months; using antibiotics in the last six months; pregnant women; woman breastfeeding; use of anti-inflammatory chronic form, presence of a systemic condition that might interfere in the course of periodontal disease (immune conditions) or systemic complications of Diabetes Mellitus, smoking.

Age minimum: 35Y
Age maximum: 0
Gender: -

Health Condition(s) or Problem(s) studied

Periodontitis, diabetes mellitus
E10-E14
K05.3

Intervention(s)

The patients will be allocated into three groups:
Group 1: Conventional periodontal therapy, four sessions will be held with scaling and root planning with a maximum interval of 1 week and with duration of 60 minutes each. Under local anesthesia will be used Gracey curettes and ultrasonic device to perform scaling and root planing subgingival (SRP). The sequence of treatment will started at the upper right quadrant, upper left, lower left quadrant and ending in right lower quadrant.

Group 2: debridement, there will be two treatment sessions with a maximum interval of 24 hours between them. Under local anesthesia ultrasonic device will be used to perform ultrasonic debridement. Each session should not exceed 60 minutes and will be treated the upper arch and then the lower jaw.

Group 3: no treatment, will be made only oral hygiene instructions during periods of 0 to 3 months, after th 6th month will be held scaling and root planing conventional. All patients will be followed by a period of six months, each group will consist of 50 individuals

Primary Outcome(s)

Reduction of periodontal probing depth using periodontal probing; reduction in plaque index using visible plaque index

Secondary Outcome(s)

Improvement in oral health; reduction of blood glucose level

Secondary ID(s)

124/2011

Source(s) of Monetary Support

Conselho Nacional de Desenvolvimento Científico e Tecnológico - Brazil

Secondary Sponsor(s)

Conselho Nacional de Desenvolvimento Científico e Tecnológico - Brazil