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

Sponsor
Postgraduate Institute of Dental Sciences Rohtak (Other)
Overall Status
Recruiting
CT.gov ID
NCT05190406
Collaborator
(none)
100
1
2
14
7.1

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Pulpotomy
  • Procedure: root canal treatment
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Masking Description:
outcome assessor will be blinded
Primary Purpose:
Treatment
Official Title:
Success and Quality of Life Following Complete Pulpotomy and Root Canal Treatment in Teeth With Clinical Signs Indicative of Irreversible Pulpitis
Actual Study Start Date :
Jun 1, 2021
Anticipated Primary Completion Date :
Jul 31, 2022
Anticipated Study Completion Date :
Aug 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Pulpotomy

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

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

Active Comparator: Root canal treatment

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

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

Outcome Measures

Primary Outcome Measures

  1. Clinical success rate [6 months and one year]

    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.

  2. Radiographic success rate [6 months and one year]

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

Secondary Outcome Measures

  1. Oral Health related quality of Life [baseline to one week, 6 months and one year]

    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.

  2. Pain assessment [baseline to one week]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
14 Years to 60 Years
Sexes Eligible for Study:
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 scoreā‰¤2.

  • Tooth with probing pocket depth and mobility are within normal limits.

  • Non-contributory medical history.

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Post graduate institute of dental sciences Rohtak Haryana India 124001

Sponsors and Collaborators

  • Postgraduate Institute of Dental Sciences Rohtak

Investigators

  • Study Director: Dr. Sanjay Tewari, MDS, POST GRADUATE INSTITUTE OF DENTAL SCIENCES, ROHTAK, Haryana, India, 124001

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sanjay Tewari, Principal, Postgraduate Institute of Dental Sciences Rohtak
ClinicalTrials.gov Identifier:
NCT05190406
Other Study ID Numbers:
  • Kanagadurga
First Posted:
Jan 13, 2022
Last Update Posted:
Jan 28, 2022
Last Verified:
Jan 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Sanjay Tewari, Principal, Postgraduate Institute of Dental Sciences Rohtak
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 28, 2022