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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: REBEC
Last refreshed on: 29 April 2013
Main ID:  RBR-24t799
Date of registration: 28/09/2012
Primary sponsor: Universidade de Brasília - Brasília, DF, Brazil
Public title: Effect of cleaning teeth in the levels of c-reactive protein in the blood of patients with severe disease in teeth and bone of the maxilla and mandible
Scientific title: Effect of nonsurgical periodontal therapy on levels of c-reactive protein in serum of subjects with severe periodontitis
Date of first enrolment: 12/06/2011
Target sample size: 55
Recruitment status: data analysis completed
URL:  http://www.ensaiosclinicos.gov.br/rg/RBR-24t799/
Study type: 
Study design:  Clinical trial, non randomized, single group, opened, single arm
 
Countries of recruitment
Brazil
Contacts
Name: Anne  Leite
Address:  Rua Copaíba lote 4 Ed Sam Marino apt 103 71919-540 Águas Claras Brazil
Telephone: +55(61)3435-8587
Email: annecarolinaleite@gmail.com
Affiliation:  Universidade de Brasília
Name: Anne  Leite
Address:  Rua Copaíba lote 4 Ed Sam Marino apt 103 71919-540 Águas Claras Brazil
Telephone: +55(61)3435-8587
Email: annecarolinaleite@gmail.com
Affiliation:  Universidade de Brasília
Key inclusion & exclusion criteria
Inclusion criteria: Subjects with periodontitis; Periodontitis group: 19 women, nine men; with at least 18 teeth in upper or lower dental arch; be aged a minimum of 20 and maximum of 45 years; no radiographic evidence of bone loss.
Exclusion criteria: History of smoking; pregnancy or lactation; periodontal therapy; antimicrobial therapy for systemic conditions or use of topical oral antibiotics in the last twelve months; diabetes; autoimmune disease; active acute infections; active severe allergies; active gastrointestinal diseases; active renal diseases; active cancer; morbid obesity (Body mass index -BMI- >40 kg/m2) or underweight (malnourished BMI <18.5 kg/m2); use of medications in the last twelve months that alter the levels of inflammatory mediators.

Age minimum: 20Y
Age maximum: 45Y
Gender: -
Health Condition(s) or Problem(s) studied
C-reactive protein, periodontal diseases
C07.465.714.533
Intervention(s)
Nonsurgical periodontal therapy, ie, scaling and root planing of the dental bacterial biofilm and subgingival calculus with specific curettes. Subjects with periodontitis were treated in three stages: mechanical periodontal therapy, sites reinstrumentation, and SPT. The first stage was carried out in less than 14 days. One month later, in stage 2, new mechanical instrumentation was performed in patients who persisted with deep pockets, BOP and calculus. At this stage, meticulous scaling and root planing were performed until reaching the following periodontal conditions: PD above 4 mm in at least three or fewer sites, PD above 5 mm in two places at most, PI less than 15% and BOP less than 10%. In Stage 3, subjects were scheduled biweekly or monthly, according to the need to control biofilm formation. SPT was performed for six months. This study is characterized as clinical trial, non randomized, single group, opened, single arm. Minimum age for inclusion: 20 years. Maximum age for inclusion: 45 years.
Primary Outcome(s)
Primary outcomes: after periodontal therapy, it was noted a decrease in all clinical periodontal parameters and levels of C-reactive protein. The reduced levels of high-sensitivity c-reactive protein after periodontal therapy was of sufficient magnitude to provide a positive change in the risk category for cardiovascular disease. The association between improvement of clinical parameters and c-reactive protein levels in patients with severe periodontitis demonstrates the systemic effects of periodontal infection. All clinical periodontal parameters were assessed by clinical examination with a manual millimetric probe. Levels of c-reactive protein were assessed by blood samples.
Secondary Outcome(s)
Secondary outcomes: it was noted a significant increase in high density lipoprotein (HDL) and no significant change in other serum lipids after periodontal therapy.
Secondary ID(s)
0067.0.012.012-08
045/2008
Source(s) of Monetary Support
Universidade de Brasília - Brasília, DF, Brazil
Secondary Sponsor(s)
Universidade de Brasília - Brasília, DF, Brazil
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