Changing apical tip size and taper during one-visit root canal to improve healing and pain
Official title: 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
Run by Postgraduate Institute of Dental Sciences Rohtak · NCT07166679 · Data updated 2026-11-12
This trial will see if using different tip sizes and tapers during a single‑visit root canal helps healing and reduces pain in adults with asymptomatic irreversible pulpitis of a lower molar.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 270 (estimated) |
| Sponsor | Postgraduate Institute of Dental Sciences Rohtak Academic / other |
| Locations | 1 site (Rohtak) |
| Status | Recruiting |
| Started | April 18, 2025 |
| Main results expected | April 18, 2026 |
| Study ends | April 18, 2027 |
| Registry record updated | September 10, 2025 |
| Trial ID | NCT07166679 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18–65 with asymptomatic pulp necrosis and a periapical radiolucency (PAI ≥3) in the mesial root of a mandibular molar and an initial apical binding file of 20 or smaller.
✕Probably not a fit
Patients who are medically compromised, pregnant or lactating, recently used antibiotics or require antibiotic prophylaxis, or have an initial apical binding file greater than 20 are excluded and unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized clinical trial compares root canal shaping with 2%, 4%, and 6% tapers in the apical third during single‑visit non‑surgical root canal treatment of mandibular molars with radiographic periapical lesions. Eligible adults (18–65) with pulpal necrosis and a mesial root PAI score ≥3 and an initial apical binding file ≤20 will be randomized to one of the three taper groups. Primary outcomes are radiographic periapical healing and patient‑reported postoperative pain measured after treatment and during follow‑up. The trial addresses limited and mixed prior clinical evidence on whether larger apical preparations or greater tapers improve outcomes.
Why it matters
Potential benefit: If successful, this could help dentists choose the optimal apical taper and preparation size to improve radiographic healing and reduce postoperative pain after one‑visit root canal treatment.
How similar studies have gone: Previous clinical trials are few and mixed—some reported no benefit from larger apical sizes while others found better success with larger preparations and greater tapers, so evidence remains inconclusive.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. 18-65 years of age of either sex 2. Asymptomatic teeth having pulpal necrosis with apical periodontitis in a mandibular molar (no response to EPT or cold test) 3. Radiographic evidence of periapical radiolucency corresponding to a periapical index (PAI) score \>/=3 in mesial root of mandibular molars Exclusion Criteria: 1. Patients who were medically compromised 2. Patients with initial apical binding file (IABF) size more than 20 3. Pregnancy; lactation \& contraceptives. 4. Positive history of antibiotic use within the past month or required antibiotic premedication for dental treatment (including infective endocarditis or pros thetic joint prophylaxis -
Where it's running
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Pgids Rohtak
Rohtak, India Recruiting
Study contacts
- Principal investigator: Dr shweta MITTAL, MDS — Pdids Rohtak
- Study coordinator: Dr shweta mittal, MDS
- Email: shwetagoelendo@gmail.com
- Phone: 9255596960
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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This trial tests whether orthograde MTA filling works as well as retrograde filling for healing after periapical surgery in back teeth with persistent symptomatic apical periodontitis.
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This trial tests whether washing the exposed pulp with calcium hypochlorite or with sodium hypochlorite during partial pulpotomy in adults helps healing and reduces pain.
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Direct pulp capping for deep and extremely deep caries in mature molars with reversible pulpitis
This study tests whether direct pulp capping works similarly for deep versus extremely deep caries in adult, mature mandibular molars with reversible pulpitis.
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This study tests whether people with different facial types have different patterns of tooth movement relapse after orthodontic treatment during the retention phase.
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This research will test whether direct pulp capping works as well for lower molars with side (proximal) cavities as for those with top (occlusal) cavities in people aged 15–40 who have reversible pulpitis.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.