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临床试验/NCT07166679
NCT07166679招募中不适用

Effect of Apical Third Enlargement to Different Taper and Master Apical Preparation Size on Periapical Healing and Postoperative Pain After Primary Single Sitting Non Surgical Root Canal Treatment

Postgraduate Institute of Dental Sciences Rohtak1 个研究点 分布在 1 个国家目标入组 270 人开始时间: 2025年4月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
270
试验地点
1
主要终点
periapical healing using the Periapical index score

研究概览

简要总结

To Determine Effect Of Apical Third enlargement To Different Taper And Master Apical Preparation Size On Periapical Healing And Postoperative Pain After Primary Single Sitting Non Surgical Root Canal Treatment : A Randomized Clinical Trial

详细描述

The primary goal of endodontic therapy is to eradicate microbial infection within the root canal system and prevent reinfection. Thorough debridement and disinfection of the apical third are crucial, as this region serves as a reservoir for residual microorganisms.

Till date, only four clinical trials have analysed the effect of apical canal preparation size on treatment outcomes. Out of the four clinical trials one retrospective in nature, Hoskinson study no improvement in radiographic and clinical outcome with an increase in the master apical file .

Souza (2012) conducted clinical trial in necrotic pulp and concluded that apical third enlargement does not alter endodontic treatment outcomes.

Saini (2012) stated that enlarging the canal three sizes beyond the first apical binding file is sufficient.

Fatima (2021) found that preparing the apical region in two sizes larger the initial apical binding file (IABF) with a 4% taper is inadequate, leading to significantly lower success rates compared to larger preparation sizes and greater tapers .

研究设计

研究类型
Interventional
分配方式
Non 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 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •18-65 years of age of either sex
  • •Asymptomatic teeth having pulpal necrosis with apical periodontitis in a mandibular molar (no response to EPT or cold test)
  • •Radiographic evidence of periapical radiolucency corresponding to a periapical index (PAI) score >/=3 in mesial root of mandibular molars

排除标准

  • •Patients who were medically compromised
  • •Patients with initial apical binding file (IABF) size more than 20
  • •Pregnancy; lactation & contraceptives.
  • •Positive history of antibiotic use within the past month or required antibiotic premedication for dental treatment (including infective endocarditis or pros thetic joint prophylaxis -

研究组 & 干预措施

GROUP A HAVING MASTER APICAL FILE SIZE # 25

Experimental

group a is further dived into 3 further subgroup a1 2% taper a2 4% taper a3 6% taper

干预措施: root canal treatment with 2% taper (Procedure)

GROUP A HAVING MASTER APICAL FILE SIZE # 25

Experimental

group a is further dived into 3 further subgroup a1 2% taper a2 4% taper a3 6% taper

干预措施: root canal treatment with 6 %taper (Procedure)

GROUP B HAVING MASTER APICAL FILE SIZE # 30

Experimental

GROUP B is further divide into 3 further subgroup b1 2% taper b2 4 % taper b3 6 % taper

干预措施: root canal treatment with 2% taper (Procedure)

GROUP A HAVING MASTER APICAL FILE SIZE # 25

Experimental

group a is further dived into 3 further subgroup a1 2% taper a2 4% taper a3 6% taper

干预措施: root canal treatment with 4% taper (Procedure)

GROUP B HAVING MASTER APICAL FILE SIZE # 30

Experimental

GROUP B is further divide into 3 further subgroup b1 2% taper b2 4 % taper b3 6 % taper

干预措施: root canal treatment with 4% taper (Procedure)

GROUP B HAVING MASTER APICAL FILE SIZE # 30

Experimental

GROUP B is further divide into 3 further subgroup b1 2% taper b2 4 % taper b3 6 % taper

干预措施: root canal treatment with 6 %taper (Procedure)

GROUP C HAVING MASTER APICAL FILE SIZE # 35

Experimental

GROUP C is further divide into 3 subgroups c1 2 % taper c2 4 % taper c3 6 % taper

干预措施: root canal treatment with 2% taper (Procedure)

GROUP C HAVING MASTER APICAL FILE SIZE # 35

Experimental

GROUP C is further divide into 3 subgroups c1 2 % taper c2 4 % taper c3 6 % taper

干预措施: root canal treatment with 4% taper (Procedure)

GROUP C HAVING MASTER APICAL FILE SIZE # 35

Experimental

GROUP C is further divide into 3 subgroups c1 2 % taper c2 4 % taper c3 6 % taper

干预措施: root canal treatment with 6 %taper (Procedure)

结局指标

主要结局

periapical healing using the Periapical index score

时间窗: 12 month follow up

Description: Periodical status will be assessed in periapical radiograph • Periapical status will be checked according to periapical index given by Orstavik * Scoring of periapical radiolucency of each tooth will be done according to the following 5 point scale (PAI score) * Score 1- Normal periapical structure * Score 2- Small changes in bone structure * Score 3- Changes in bone structure with some mineral loss * Score 4- Periodontitis with well-defined radiolucent area * Score 5- Severe periodontitis with exacerbating features Time Frame: 12MONTHS

次要结局

  • post operative pain(Baseline and at 24 hours, Day 2, Day 3, Day 4, Day 5, Day 6 and Day 7 after the treatment)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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