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临床试验/NCT02379975
NCT02379975已完成不适用

Evaluation of Non-surgical Periodontal Therapy in Patients With Rheumatoid Arthritis

CAIO VINICIUS GONÇALVES ROMAN TORRES0 个研究点目标入组 56 人开始时间: 2013年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
56
主要终点
periodontal probing depth (PD)

研究概览

简要总结

Some clinical and epidemiological studies have revealed a high prevalence of periodontitis and tooth loss in patients with rheumatoid arthritis. The aim of this study was to evaluate the efficacy of periodontal scaling and oral hygiene instruction for patients with mild chronic periodontitis and rheumatoid arthritis through clinical periodontal parameters and laboratory tests for CRP (C- reactive protein) and ESR (erythrocyte sedimentation rate).

详细描述

This longitudinal study was approved by the Research Committee of the Santos Metropolitan University, and all individuals had access to the terms of consent. A total of 56 individuals with rheumatoid arthritis were assessed, and the investigators selected 12 women with a mean age of 45.38 who had been diagnosed with rheumatoid arthritis (RA) and who also had mild chronic periodontitis (PD). All of the patients were referred from the outpatient specialty medicals service and the rheumatologist's specialty outpatient clinic of the Metropolitan University of Santos diagnosed and evaluated individuals in the test group and the control group. The control group was composed of individuals who initiated periodontal treatment, did not have any systemic involvement, and had probing depth compatible with the individuals in the test group. The criteria for participation in the study included not having any dental procedure performed in the last six months, not having used antibiotic medication in the last six months, except for the use of drugs that could alter salivary flow (antidepressants, anxiolytics, antihistamines, and diuretics among others), not smoking, and not wearing braces.

The main parameters for the diagnosis of RA include counting the number of painful joints and the number of swollen joints, inflammatory activity (ESR and PCR), assessment of pain intensity, and assessment of joint mobility and functional capacity. Before the start of periodontal treatment, these tests were performed, and blood tests (ESR and PCR) were requested and evaluated by the rheumatologist in charge. The healthy subjects (control group) also underwent blood tests.

Upon completion of amamneses, periodontal clinical examinations were performed by a previously trained and calibrated periodontist, and in the sample studied, 10% were examined twice for each of the clinical criteria in order to obtain the intra-examiner reliability as measured by Kappa statistics (0.87).

The investigators observed the clinical parameters of periodontal probing depth (PD) in six points per tooth, and plaque index (PI) and gingival index (GI), conducted dichotomously for cheeks, buccal, mesial, distal and lingual/ palatal. All of the participants received radiographic, periapical, dental examinations in order to check the height level of the cortical bone.

Subjects received oral hygiene devices and underwent therapy for full mouth disinfection, and patients followed the protocol of holding two sessions with an interval of less than 24 hours between sessions. At the beginning of each session, oral hygiene instructions were given to each subject individually and the investigators tried to teach patients the correct way of using a brush and floss. The treatment was performed by scraping by a single periodontist who was blinded to the participants and the data obtained in clinical trials.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
30 Years 至 70 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • female gender
  • in control group, probing depth compatible with the individuals in the test group

排除标准

  • not having any dental procedure performed in the last six months,
  • not having used antibiotic medication in the last six months,
  • except for the use of drugs that could alter salivary flow (antidepressants, anxiolytics, antihistamines, and diuretics among others),
  • not smoking,
  • and not wearing braces.

结局指标

主要结局

periodontal probing depth (PD)

时间窗: 90 days after periodontal therapy

次要结局

  • plaque index (PI)(90 days after periodontal therapy)
  • gingival index (GI)(90 days after periodontal therapy)
  • blood test erythrocyte sedimentation rate (ESR)(90 days after periodontal therapy)
  • blood test C-reactive protein (CRP)(90 days after periodontal therapy)

研究者

发起方
CAIO VINICIUS GONÇALVES ROMAN TORRES
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

CAIO VINICIUS GONÇALVES ROMAN TORRES

PhD in Periodontology

Universidade Metropolitana de Santos

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