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临床试验/NCT05741970
NCT05741970已完成不适用

Interaction Between Hypertension and Periodontitis

Gazi University0 个研究点目标入组 42 人开始时间: 2017年1月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
42
主要终点
Plaque index and Gingival index

研究概览

简要总结

Objective:The possible association between hypertension and periodontitis and the effect of hypertension on periodontal treatment were investigated by evaluating salivary and gingival crevicular fluid (GCF) interleukin (IL)-6 and C reactive protein (CRP) levels. Methods:Forty two healthy individuals without any previously diagnosed systemic disease [10 periodontally healthy (control) and 10 periodontitis (CP)] and subjects with hypertension [13 periodontally healthy (HP) and 9 with periodontitis (CP + HP)] participated in the study. GCF and saliva samples were obtained at baseline and four weeks after Phase I periodontal treatment. Biochemical parameters were analyzed using ELISA. Results:Before the periodontal treatment, significantly higher GCF IL-6 and CRP levels were detected in CP+HP and CP groups compared to HP and control groups (p<0.01). Salivary CRP level in CP+HP group was found to be higher than the control group (p<0.05). Statistically significant gingival and plaque index measurements (p<0.01) might suggest a possible effect of hypertension on periodontal status. Periodontal treatment significantly improved the clinical indices, however biochemical parameters did not change after the treatment. Conclusion:the association of hypertension with periodontitis through local salivary and GCF mediators might be possible in disease process.

详细描述

Forty-two participants were included in the study. The study groups consisted of 20 healthy individuals without any previously diagnosed systemic disease (10 periodontally healthy and 10 with periodontitis) and 22 patients with hypertension (13 periodontally healthy and 9 with periodontitis). The patient population was randomly selected among the patients who referred to Periodontology Clinic. Hypertensive patients with at least 5 years of follow up were included in the hypertension group. Hypertension patients treated with antihypertensive drugs known to cause gingival overgrowth were excluded from the study.

Other exclusion criteria were diabetes mellitus, high cholesterol levels, CVD and drugs usage other than antihypertensive drugs. A calibrated examiner performed a comprehensive periodontal examination included plaque index (Silness & Loe, 1964) (PI), gingival index (Loe & Silness, 1963) (GI), probing depth (PD), clinical attachment level (CAL) and bleeding on probing (BOP). The measurements were made at six sites per tooth (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual and disto-lingual) using a periodontal probe (Williams periodontal probe, Nordent Manufacturing, Elk Grove Village, IL., USA) To perform the intra-examiner calibration, PD and CAL were measured twice at six sites of each tooth within 24 hours. Intra-examiner agreement was at least 90% for both PD and CAL within 1 mm. Examiner who recorded the clinical indexes was blinded to the systemical status of the patients and the periodontologists who were responsible for patients periodontal treatment were not blinded because of the anesthesia applied to hypertension patients and the precautions needed to be taken.

During the study period, patients were instructed not to use any local/systemic antibiotics and antimicrobial agents.Patients diagnosed with periodontitis had Stage II periodontitis in a generalized pattern with probing depths of 3-4mm. The diagnosis was performed based on criteria that maximum probing depth ≤5 mm, mostly horizontal loss and >30% of teeth involved. Healthy periodontium was identified as the presence of BOP≤10% and PD≤3 mm.The deepest four pockets of non-adjacent single rooted teeth were selected for GCF sampling. The participants were distributed into four groups; healthy subjects with healthy periodontal condition (control), healthy subjects with periodontitis (CP), hypertension patients with periodontitis (CP + HP) and hypertension patients with healthy periodontal condition (HP). The study was approved by the local ethics committee (291208/11) and all patients signed an informed consent form. Exclusion criteria were smoking, pregnancy, established secondary hypertension diagnosis, other systemic diseases and previous periodontal and/or antibiotic treatment within the last six months. All patients with periodontitis received phase I periodontal therapy including oral hygiene instruction (OHI) and scaling/root planning (SRP) without any antimicrobial therapy. GCF and saliva samples were obtained and clinical measurements were performed at baseline (before treatment (BT) and four weeks after the phase I periodontal therapy (AT). The timeline for the phase I therapy (within 2 weeks of baseline examination 4 days). Primary biochemical outcome measures included salivary and GCF IL-6 and CRP, and primary periodontal outcome measures were PI, GI, PD, CAL and BOP. Secondary outcome measure was GCF volume.

GCF and saliva sampling and processing The GCF sampling site was gently air dried and supragingival plaque was removed.

The area was carefully isolated with cotton rolls in order to prevent contamination.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Outcomes Assessor)

盲法说明

Examiner who recorded the clinical indexes was blinded to the systemical status of the patients and the periodontologists who were responsible for patients periodontal treatment were not blinded because of the anesthesia applied to hypertension patients and the precautions needed to be taken.

入排标准

年龄范围
39 Years 至 58 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Hypertensive patients with at least 5 years of followup were included in the hypertension group.

排除标准

  • Hypertension patients treated with antihypertensive drugs known to cause gingival overgrowth were excluded from the study.
  • Other exclusion criteria were diabetes mellitus, high cholesterol levels, CVD and drugs usage other than antihypertensive drugs.

结局指标

主要结局

Plaque index and Gingival index

时间窗: change from baseline to postoperative 4 weeks

scores from 1-3

Salivary and Gingival crevicular fluid Interleukin-6 and CRP

时间窗: change from baseline to postoperative 4 weeks

pg/mL unite

Pocket depth and Clinical attachment level

时间窗: change from baseline to postoperative 4 weeks

mm

Bleeding on probing

时间窗: change from baseline to postoperative 4 weeks

percentage

次要结局

  • Gingival crevicular fluid volume(change from baseline to postoperative 4 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nurdan Ozmeric

Professor

Gazi University

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