Success and Quality of Life Following Complete Pulpotomy and Root Canal Treatment
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2021
CompletedFirst Submitted
Initial submission to the registry
December 10, 2021
CompletedFirst Posted
Study publicly available on registry
January 13, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2022
CompletedJanuary 28, 2022
January 1, 2022
1.2 years
December 10, 2021
January 13, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
6 months and one year
Radiographic success rate
Radiographic success criteria No pathosis evident on the radiograph Periapical Index score 1 or 2
6 months and one year
Secondary Outcomes (2)
Oral Health related quality of Life
baseline to one week, 6 months and one year
Pain assessment
baseline to one week
Study Arms (2)
Pulpotomy
EXPERIMENTALcomplete pulpotomy will be done till the level of root canal orifice.
Root canal treatment
ACTIVE COMPARATORSingle visit root canal treatment will be done according to standard protocol.
Interventions
After achieving hemostasis, in pulpotomy group bioceramic material will be placed and then permanent restoration will be done.
Single visit root canal treatment will be done according to standard protocol.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Post graduate institute of dental sciences
Rohtak, Haryana, 124001, India
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Dr. Sanjay Tewari, MDS
POST GRADUATE INSTITUTE OF DENTAL SCIENCES, ROHTAK, Haryana, India, 124001
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- outcome assessor will be blinded
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal
Study Record Dates
First Submitted
December 10, 2021
First Posted
January 13, 2022
Study Start
June 1, 2021
Primary Completion
July 31, 2022
Study Completion
August 1, 2022
Last Updated
January 28, 2022
Record last verified: 2022-01