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临床试验/NCT05009355
NCT05009355Unknown早期 1 期

The Effect of Vitamin C Supplementation on GCF Total Oxidant Capacity in Smoker Patients With Periodontitis Following Non-surgical Periodontal Therapy. A Randomized Controlled Clinical Trial

Cairo University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年1月11日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
入组人数
40
试验地点
1
主要终点
Total Oxidant Capacity

研究概览

简要总结

The effect of vitamin C supplementation on GCF total oxidant capacity in smoker patients with periodontitis following non-surgical periodontal therapy.

详细描述

All subjects were screened by comprehensive periodontal examination and full periodontal charts were obtained and full-mouth periapical radiographs were taken using the long cone parallel technique at the time of the initial examination to confirm the diagnosis.

Both groups (smokers with stage III-IV grade B periodontitis) received full mouth scaling and root planing using ultrasonic scaler and hand instruments under local anesthesia, completed over 2 visits. Patients were given careful instruction in self performed plaque control measures: twice daily tooth brushing with a brush and tooth paste and once daily interdental cleaning using triangular wooden tooth picks and/or interdental brushes rinsing with 0.125% Chlorhexidine HCL mouthwash (Hexitol® ) to be used twice daily for 2 weeks. Group II received antioxidant vit C 2 grams / day for four weeks.

Collection of gingival crevicular fluid (GCF) sample:

In both groups, GCF samples were collected at the initial visit and collected again 3 months after non-surgical treatment as follows : at the selected area (the most periodontally affected site), all clinically detected supragingival plaque were removed carefully to minimize contamination of the paper strips by the plaque . The teeth selected were then gently washed with water, and the sites under study were isolated with cotton rolls to prevent contamination with saliva and gently dried with an air syringe . Filter paper strips were placed at the entrance of the crevice and were left in place for 30 secs ) and then placed in plastic eppendorf. Strips with any plaque, saliva, or blood contamination were discarded .The sample from the individual site was stored at -80°C for later processing . GCF was then extracted and assayed for the content of total oxidant capacity.

Quantitation of TOC in GCF:

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
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • all patients were systemically healthy
  • stage III-IV grade B periodontitis
  • A minimum of two non-adjacent teeth having sites with ≥ 5 mm interdental clinical attachment loss .
  • Radiographic bone loss extending to middle third of root and beyond .
  • All patients were heavy smokers i.e ≥ 20 cigarettes / day .

排除标准

  • patients who had received any periodontal or antibiotic treatment or vitamins supplementation during the last six months.
  • pregnant or lactating women
  • patients who refused to provide written informed consent

研究组 & 干预措施

experimental

Experimental

A Group: Consisted of 20 patients who were treated with scaling and root planing in conjunction with 2g antioxidant Vit (C)

干预措施: Vitamin C (Drug)

结局指标

主要结局

Total Oxidant Capacity

时间窗: one month

unit

次要结局

  • probing depth(one month)
  • plaque index(one month)
  • Gingival index(one month)

研究者

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

Abeer hassan sharafuddin

lecturer

Cairo University

研究点 (1)

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