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临床试验/CTRI/2022/02/040315
CTRI/2022/02/040315尚未招募不适用

Evaluation of efficacy of ozonated and non-ozonated 2% Chlorhexidine gluconate and 0.1% Octinidine hydrochloride with and without hypochlorite application in single visit endodontic retreatment: A randomised clinical trial.

Pacific dental college and hospital1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2022年2月21日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
120
试验地点
1
主要终点
Pain after secondary endodontic treatment

研究概览

简要总结

**Aim:**To compare the effect of different irrigation regimes on post endodontic pain in patients undergoing single-visit endodontic retreatment, with 2% Chlorhexidine and 0.1% Octinidine with and without ozone and hypochlorite.

Materials and Methods: Adult patients requiring retreatment were selected. Following local anesthesia and isolation, access cavities were modified. Standard retreatment protocol was followed and patients were randomly assigned into groups -

Group 1 - 2% Chlorhexidine with sodium hypochlorite (CHX) (Control group)

Group 2 - 2% Ozonated chlorhexidine without sodium hypochlorite (OCHX).

Group 3 - 2% Ozonated chlorhexidine with sodium hypochlorite (OCHXH).

Group 4 - 0.1% Octinidine with sodium hypochlorite (OCT).

Group 5 - 0.1% Ozonated octinidine without sodium hypochlorite (OOCT).

Group 6 - 0.1% Ozonated octinidine with sodium hypochlorite (OOCTH).

Each group was irrigated with 15 ml of ozonated/non - ozonated irrigant (CHX/ OCT) for 3-5 minutes with ultrasonic agitation. Obturation and core built-up were completed at the same appointment. The level of discomfort at baseline, after 6, 12, 24, 48 hours, and 7 days were recorded on the Visual Analogue Scale. Pain levels were recorded, tabulated, and subjected to statistical analysis using a two-way analysis of variance followed by post hoc Bonferroni test.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
19.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Patients with single rooted, root-filled tooth with persistent apical periodontitis / symptomatic teeth with or without lesion requiring endodontic retreatment with radiographic/clinical evidence of previous endodontic treatment and periradicular disease were included in the study were recruited.
  • Other inclusion criteria were endodontic treatment done > 3 years back, sufficient coronal tooth structure for adequate isolation with rubber dam, gutta-percha material within 4–7 mm of the radiographic apex and no direct exposure of root canal filling material to oral cavity.

排除标准

  • Medically compromised patients, patients allergic to the local anesthetic agent/ irrigants/ ozone and patients with recent myocardial infarction, acute alcohol intoxication, active bleeding, uncontrolled hyperthyroidism, thrombocytopenia, glucose 6 phosphatase deficiency (contraindications of ozone therapy) were excluded.
  • Patients under 18 years of age, with swelling and/or acute apical abscess; analgesic/ antibiotic/ corticosteroid / anti-inflammatory taken within the past 7 days before treatment, and multiple teeth (to eliminate the possibility of pain referral), periodontal pocket deeper than 4 mm, intraradicular posts were excluded.

结局指标

主要结局

Pain after secondary endodontic treatment

时间窗: At baseline, after 6, 12, 24, 48 hours, and 7 days

次要结局

  • Pain after secondary endodontic treatment(At baseline, after 6, 12, 24, 48 hours, and 7 days)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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