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

NCT07166679 | Recruiting

• 1 other identifier: sahil
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

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

Conditions

Asymptomatic Irreversible Pulpitis

Outcome Measures

Primary Outcomes (1)

• periapical healing using the Periapical index score

  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

  12 month follow up

Secondary Outcomes (1)

• post operative pain

  Baseline and at 24 hours, Day 2, Day 3, Day 4, Day 5, Day 6 and Day 7 after the treatment

Study Arms (3)

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

Procedure: root canal treatment with 2% taper; Procedure: root canal treatment with 4% taper; Procedure: root canal treatment with 6 %taper

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

Procedure: root canal treatment with 2% taper; Procedure: root canal treatment with 4% taper; Procedure: root canal treatment with 6 %taper

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

Procedure: root canal treatment with 2% taper; Procedure: root canal treatment with 4% taper; Procedure: root canal treatment with 6 %taper

Interventions

root canal treatment with 2% taper PROCEDURE

root canal treatment with 2%taper

GROUP A HAVING MASTER APICAL FILE SIZE # 25; GROUP B HAVING MASTER APICAL FILE SIZE # 30; GROUP C HAVING MASTER APICAL FILE SIZE # 35

root canal treatment with 4% taper PROCEDURE

root canal treatment with 4 %taper

GROUP A HAVING MASTER APICAL FILE SIZE # 25; GROUP B HAVING MASTER APICAL FILE SIZE # 30; GROUP C HAVING MASTER APICAL FILE SIZE # 35

root canal treatment with 6 %taper PROCEDURE

root canal treatment with 6 %taper

GROUP A HAVING MASTER APICAL FILE SIZE # 25; GROUP B HAVING MASTER APICAL FILE SIZE # 30; GROUP C HAVING MASTER APICAL FILE SIZE # 35

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 -

Sponsors & Collaborators

• Postgraduate Institute of Dental Sciences Rohtak: lead

Study Sites (1)

Pgids Rohtak

Rohtak, India

RECRUITING

Study Officials

• Dr shweta MITTAL, MDS

  PDIDS ROHTAK

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr shweta mittal, MDS

CONTACT

9255596960; shwetagoelendo@gmail.com

DR sahil saini, PG STUDENT

CONTACT

7015863706; sahil.saini130897@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2025
• First Posted: September 10, 2025
• Study Start: April 18, 2025
• Primary Completion: April 18, 2026
• Study Completion (Estimated): April 18, 2027
• Last Updated: September 10, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)