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

NCT ID: NCT05190406

Last Updated: 2022-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-01

Study Completion Date

2022-08-01

Brief Summary

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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

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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.

Conditions

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Irreversible Pulpitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
outcome assessor will be blinded

Study Groups

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Pulpotomy

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

Group Type EXPERIMENTAL

Pulpotomy

Intervention Type PROCEDURE

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

Root canal treatment

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

Group Type ACTIVE_COMPARATOR

root canal treatment

Intervention Type PROCEDURE

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

Interventions

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Pulpotomy

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

Intervention Type PROCEDURE

root canal treatment

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

14 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Postgraduate Institute of Dental Sciences Rohtak

OTHER

Sponsor Role lead

Responsible Party

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Sanjay Tewari

Principal

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dr. Sanjay Tewari, MDS

Role: STUDY_DIRECTOR

POST GRADUATE INSTITUTE OF DENTAL SCIENCES, ROHTAK, Haryana, India, 124001

Locations

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Post graduate institute of dental sciences

Rohtak, Haryana, India

Site Status RECRUITING

Countries

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India

Central Contacts

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DR. Pankaj Sangwan, MDS

Role: CONTACT

9996112202

Kanagadurga R, MDS

Role: CONTACT

9751505590

Other Identifiers

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Kanagadurga

Identifier Type: -

Identifier Source: org_study_id

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