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

Primary Purpose

Irreversible Pulpitis

Status
Recruiting
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Pulpotomy
root canal treatment
Sponsored by
Postgraduate Institute of Dental Sciences Rohtak
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irreversible Pulpitis focused on measuring pulpitis, pulpotomy, single visit root canal treatment, bioceramic material

Eligibility Criteria

14 Years - 60 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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:

  • 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

Sites / Locations

  • Post graduate institute of dental sciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pulpotomy

Root canal treatment

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.

Full Information

First Posted
December 10, 2021
Last Updated
January 13, 2022
Sponsor
Postgraduate Institute of Dental Sciences Rohtak
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1. Study Identification

Unique Protocol Identification Number
NCT05190406
Brief Title
Success and Quality of Life Following Complete Pulpotomy and Root Canal Treatment
Official Title
Success and Quality of Life Following Complete Pulpotomy and Root Canal Treatment in Teeth With Clinical Signs Indicative of Irreversible Pulpitis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
July 31, 2022 (Anticipated)
Study Completion Date
August 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Postgraduate Institute of Dental Sciences Rohtak

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irreversible Pulpitis
Keywords
pulpitis, pulpotomy, single visit root canal treatment, bioceramic material

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
outcome assessor will be blinded
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pulpotomy
Arm Type
Experimental
Arm Description
complete pulpotomy will be done till the level of root canal orifice.
Arm Title
Root canal treatment
Arm Type
Active Comparator
Arm Description
Single visit root canal treatment will be done according to standard protocol.
Intervention Type
Procedure
Intervention Name(s)
Pulpotomy
Intervention Description
After achieving hemostasis, in pulpotomy group bioceramic material will be placed and then permanent restoration will be done.
Intervention Type
Procedure
Intervention Name(s)
root canal treatment
Intervention Description
Single visit root canal treatment will be done according to standard protocol.
Primary Outcome Measure Information:
Title
Clinical success rate
Description
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
Title
Radiographic success rate
Description
Radiographic success criteria No pathosis evident on the radiograph Periapical Index score 1 or 2
Time Frame
6 months and one year
Secondary Outcome Measure Information:
Title
Oral Health related quality of Life
Description
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
Title
Pain assessment
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
DR. Pankaj Sangwan, MDS
Phone
9996112202
Email
drps_1@yahoo.co.in
First Name & Middle Initial & Last Name or Official Title & Degree
Kanagadurga R, MDS
Phone
9751505590
Email
durga200295@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Sanjay Tewari, MDS
Organizational Affiliation
POST GRADUATE INSTITUTE OF DENTAL SCIENCES, ROHTAK, Haryana, India, 124001
Official's Role
Study Director
Facility Information:
Facility Name
Post graduate institute of dental sciences
City
Rohtak
State/Province
Haryana
ZIP/Postal Code
124001
Country
India
Individual Site Status
Recruiting

12. IPD Sharing Statement

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

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