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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

ConditionAsymptomatic Irreversible Pulpitis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorPostgraduate Institute of Dental Sciences Rohtak

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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 -

Trial design

Design model

Parallel

Treatments tested in this trial

  • root canal treatment with 2% taper

    Procedure/Surgery

    root canal treatment with 2%taper

  • root canal treatment with 4% taper

    Procedure/Surgery

    root canal treatment with 4 %taper

  • root canal treatment with 6 %taper

    Procedure/Surgery

    root canal treatment with 6 %taper

Treatment groups

270 Participants
are divided into 3 treatment groups
Group A: GROUP A HAVING MASTER APICAL FILE SIZE # 25Experimental treatment 3 interventions
Group B: GROUP B HAVING MASTER APICAL FILE SIZE # 30Experimental treatment 3 interventions
Group C: GROUP C HAVING MASTER APICAL FILE SIZE # 35Experimental treatment 3 interventions

Trial outcomes

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

Time frame
12 month follow up

Secondary outcomes

1

post operative pain

Post Operative Pain To assess incidence and intensity of pain postoperatively at every 24 hours till 7 days using Visual analogue Scale of 0 to 100 millimeter line. Score 0 means no pain and Score100 means maximum pain. To assess incidence and intensity of pain postoperatively at every 24 hours till 7 days using Visual analogue Scale of 0 to 100 millimeter line. Score 0 means no pain and Score 100 means maximum pain

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Postgraduate Institute of Dental Sciences Rohtak

Lead sponsor

Source ClinicalTrials.gov
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