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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 270
- Locations
- 1
- Primary Endpoint
- periapical healing using the Periapical index score
Study Overview
Brief Summary
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
Detailed Description
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 .
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Exclusion Criteria
- •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 -
Arms & Interventions
GROUP A HAVING MASTER APICAL FILE SIZE # 25
group a is further dived into 3 further subgroup a1 2% taper a2 4% taper a3 6% taper
Intervention: root canal treatment with 2% taper (Procedure)
GROUP A HAVING MASTER APICAL FILE SIZE # 25
group a is further dived into 3 further subgroup a1 2% taper a2 4% taper a3 6% taper
Intervention: root canal treatment with 6 %taper (Procedure)
GROUP B HAVING MASTER APICAL FILE SIZE # 30
GROUP B is further divide into 3 further subgroup b1 2% taper b2 4 % taper b3 6 % taper
Intervention: root canal treatment with 2% taper (Procedure)
GROUP A HAVING MASTER APICAL FILE SIZE # 25
group a is further dived into 3 further subgroup a1 2% taper a2 4% taper a3 6% taper
Intervention: root canal treatment with 4% taper (Procedure)
GROUP B HAVING MASTER APICAL FILE SIZE # 30
GROUP B is further divide into 3 further subgroup b1 2% taper b2 4 % taper b3 6 % taper
Intervention: root canal treatment with 4% taper (Procedure)
GROUP B HAVING MASTER APICAL FILE SIZE # 30
GROUP B is further divide into 3 further subgroup b1 2% taper b2 4 % taper b3 6 % taper
Intervention: root canal treatment with 6 %taper (Procedure)
GROUP C HAVING MASTER APICAL FILE SIZE # 35
GROUP C is further divide into 3 subgroups c1 2 % taper c2 4 % taper c3 6 % taper
Intervention: root canal treatment with 2% taper (Procedure)
GROUP C HAVING MASTER APICAL FILE SIZE # 35
GROUP C is further divide into 3 subgroups c1 2 % taper c2 4 % taper c3 6 % taper
Intervention: root canal treatment with 4% taper (Procedure)
GROUP C HAVING MASTER APICAL FILE SIZE # 35
GROUP C is further divide into 3 subgroups c1 2 % taper c2 4 % taper c3 6 % taper
Intervention: root canal treatment with 6 %taper (Procedure)
Outcomes
Primary Outcomes
periapical healing using the Periapical index score
Time Frame: 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
Secondary Outcomes
- post operative pain(Baseline and at 24 hours, Day 2, Day 3, Day 4, Day 5, Day 6 and Day 7 after the treatment)