Comparative Evaluation of Partial and Complete Pulpotomy in Permanent Molars

May 23, 2020 updated by: Postgraduate Institute of Dental Sciences Rohtak

Comparative Evaluation of Partial and Complete Pulpotomy in Mature Permanent Molars With Clinical Signs Indicative of Irreversible Pulpitis

This study will compare the outcome of partial pulpotomy and complete pulpotomy in mature permanent molars with clinical signs indicative of irreversible pulpitis

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

After thorough history and clinical and radio graphic examination, and confirmation of eligibility for the study, written informed consent will be taken after explaining the procedure and its associated risks and benefits. Clinical diagnosis of irreversible pulpitis will be established based on a history of spontaneous pain or pain exacerbated by cold stimuli and lasting for a few seconds to several hours (lingering pain) compared to control teeth and which is reproducible using cold testing. Once included, study subjects will be randomly allocated to either Complete Pulpotomy group or Partial Pulpotomy group. (Mineral Trioxide Aggregate) MTA will be used as pulpotomy agent. A layer of resin modified Glass Ionomer liner will be placed over the MTA and tooth will be permanently restored with composite resin in second appointment.

Pain analysis will be carried out preoperatively and postoperatively at every 24 hours till 7 days after intervention. All the subjects will be followed up for evaluation of success at every 3 months from baseline to 1 year.

Study Type

Interventional

Enrollment (Anticipated)

74

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Haryana
      • Rohtak, Haryana, India, 124001
        • Ankita Ramani

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 38 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria: Inclusion criteria

  • The patient should be ≥18 years of age.
  • Restorable molar teeth.
  • Tooth should give positive response to pulp sensibility testing.
  • Clinical diagnosis of irreversible pulpitis.
  • Tooth with probing pocket depth and mobility are within normal limits.
  • No signs of pulpal necrosis including sinus tract or swelling.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Complete Pulpotomy
In case of complete pulpotomy procedure the exposed pulp tissue will be amputated using sterile bur in high speed hand piece to the level of canal orifices.
Procedure: Pulpotomy to the level of canal orifices
Pulp tissue will be removed till the level of canal orifices.
Active Comparator: Partial Pulpotomy
In case of partial pulpotomy procedure the exposed pulp tissue will be amputated using a sterile bur in the high speed hand piece to a depth of 2-3 mm.
Procedure: Pulpotomy up to superficial 2-3 mm of pulp chamber
Only superficial pulp from the chamber will be removed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Success and radiographic success
Time Frame: Baseline to 12 Months

CLINICAL SUCCESS CRITERIA:

Absence of spontaneous pain, discomfort, swelling, sinus tract or tenderness to palpation or percussion.

RADIOGRAPHIC SUCCESS CRITERIA:

No pathosis evident on the radiograph such as root resorption, furcal pathosis or new periapical pathosis.

Periapical Index score 1 or 2 according to Orstavic et al.

Evaluation of both clinical and radiographic outcome is must for analyzing the actual success of therapeutic technique. Number of participants fulfilling both clinical as well as radiographic success criteria will be considered in success category.
Baseline to 12 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain analysis
Time Frame: Baseline to 7 days
To assess incidence and intensity of pain postoperatively at every 24 hours till 7 days using Visual analogue Scale of 0 to 10 Centimetere line. Score 0 means no pain and Score 10 means maximum pain.
Baseline to 7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Postgraduate Institute of Dental Sciences Rohtak

Investigators

  • Principal Investigator: ANKITA RAMANI, Post graduate institute of dental sciences, Rohtak

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2019

Primary Completion (Anticipated)

June 30, 2020

Study Completion (Anticipated)

June 30, 2020

Study Registration Dates

First Submitted

May 12, 2020

First Submitted That Met QC Criteria

May 17, 2020

First Posted (Actual)

May 21, 2020

Study Record Updates

Last Update Posted (Actual)

May 27, 2020

Last Update Submitted That Met QC Criteria

May 23, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dr. Ankita Ramani

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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