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Status unknownNCT05190406Updated Jan 28, 2022

Success and Quality of Life Following Complete Pulpotomy and Root Canal Treatment

An interventional study of Pulpotomy and root canal treatment in Irreversible Pulpitis, sponsored by Postgraduate Institute of Dental Sciences Rohtak. Status unknown at 1 site in India. Open to participants aged 14 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-01-28.

Sponsored by Postgraduate Institute of Dental Sciences Rohtak · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2022), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Jun 2021, registered Dec 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
14 Years to 60 Years
Sex
All
01

Study summary

The purpose of this study is to compare the Success and quality of life following complete pulpotomy and root canal treatment in teeth with clinical signs indicative of irreversible pulpitis.

Read the detailed description

After thorough history and clinical and radiographic examination, and confirmation of eligibility for the study, risks and benefits associated with the procedure will be explained and written informed consent will be taken from the patients. Study subjects will be randomly allocated to either Complete pulpotomy or Root canal treatment Group.

02

Conditions studied

  • Irreversible Pulpitis

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Keywords

  • pulpitis
  • pulpotomy
  • single visit root canal treatment
  • bioceramic material
03

In context

Pulpitis

302 studies on the registry are indexed under Pulpitis; 67 are open to participants now.

This study's planned enrollment of 100 is above the median of 62 across 275 interventional studies indexed under Pulpitis.

Browse Pulpitis studies →

Lead sponsor

Postgraduate Institute of Dental Sciences Rohtak is the lead sponsor of 209 studies on the registry; 71 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
14 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Mature permanent restorable mandibular molar teeth.
  • Tooth should give positive response to pulp sensibility testing.
  • Clinical diagnosis of irreversible pulpitis with PAI score≤2.
  • Tooth with probing pocket depth and mobility are within normal limits.
  • Non-contributory medical history.

Exclusion criteria

Exclusion Criteria:

  • Teeth with immature roots.
  • No pulp exposure after caries excavation.
  • Bleeding could not be controlled in 6 minutes.
  • Insufficient bleeding after pulp exposure, the pulp is judged necrotic or partially necrotic.
  • Absence of antagonist tooth.
  • Positive history of antibiotic use in the past 1 month or requiring antibiotic prophylaxis
  • Had taken analgesic in past 3 days.
  • Tooth with periapical lesion visible on radiograph
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Pulpotomy

    complete pulpotomy will be done till the level of root canal orifice.

    Procedure: Pulpotomy

  • Active comparator
    Root canal treatment

    Single visit root canal treatment will be done according to standard protocol.

    Procedure: root canal treatment

Interventions

  • ProcedurePulpotomy

    After achieving hemostasis, in pulpotomy group bioceramic material will be placed and then permanent restoration will be done.

  • Procedureroot canal treatment

    Single visit root canal treatment will be done according to standard protocol.

06

What researchers measure

Primary outcomes

  1. Clinical success rate

    Clinical success criteria No history of spontaneous pain No tenderness to palpation or percussion Normal mobility and probing pocket depth. Soft tissues around tooth are normal with no swelling or sinus tract.

    Time frame: 6 months and one year

  2. Radiographic success rate

    Radiographic success criteria No pathosis evident on the radiograph Periapical Index score 1 or 2

    Time frame: 6 months and one year

Secondary outcomes

  1. Oral Health related quality of Life

    Oral Health Impact Profile-14 questionnaire of score 0-4 will be used to assess the quality of life. Score 0 means never and 4 means very often affected the quality of life.

    Time frame: baseline to one week, 6 months and one year

  2. Pain assessment

    Visual analogue Scale of 0 to 10 Centimetere line will be used to assess pain. Score 0 means no pain and Score 10 means maximum pain.

    Time frame: baseline to one week

07

Study locations

1 of 1 sites recruiting
  • Post graduate institute of dental sciences
    Rohtak, Haryana 124001, India
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 28, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05190406
Lead sponsor
Postgraduate Institute of Dental Sciences Rohtak
Responsible party
Sanjay Tewari (Principal, Postgraduate Institute of Dental Sciences Rohtak) — Principal investigator
First posted
Jan 13, 2022
Start date
Jun 1, 2021
Primary completion
Jul 31, 2022 (estimated)
Completion
Aug 1, 2022 (estimated)
Last update
Jan 28, 2022

Study contacts

DR. Pankaj Sangwan, MDS
Contact
drps_1@yahoo.co.in
9996112202
Kanagadurga R, MDS
Contact
durga200295@gmail.com
9751505590
Dr. Sanjay Tewari, MDS
study director · POST GRADUATE INSTITUTE OF DENTAL SCIENCES, ROHTAK, Haryana, India, 124001

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

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