Outcome of Pulpotomy Versus Root Canal Therapy

October 24, 2022 updated by: Jordan University of Science and Technology

Quality of Life, Satisfaction and Outcome After Full Pulpotomy Compared to Root Canal Therapy

Root canal therapy (RCT) is indicated once the pulp is diagnosed with irreversible pulpitis. Despite favorable success rate reported for RCT in vital cases, it is time consuming, and might increases fracture susceptibility of teeth. With the advancement of materials and better understanding of pulpal healing, vital pulp therapy is practiced as an alternative treatment with high success rate. The aim of this study is to explore the outcome, quality of life and patient satisfaction after full pulpotomy compared to RCT.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Permanent molar teeth with carious pulp exposure and mature roots as evident on the preoperative periapical radiograph will be included in the study. The teeth will be randomly divided into 2 groups (n=30). The first group will be treated with Biodentine full pulpotomy and the second group will be endodontically treated. Based on a previously validated questionnaire. The quality of life and satisfaction of patients after pulpotomy treatment will be evaluated compared to those after endodontic treatment. Clinical and radiographic assessment of the treated teeth will be done 3, 6 and 12 months postoperatively. Pain level will be recorded preoperatively and 1, 2, 3, 5 and 7 days after treatment.

The questionnaire consists of five components:

  1. Characteristics of the patient; including age, gender, socioeconomic status, smoking, oral hygiene practices, frequency of dental visits, and dental history.

  2. Postoperative complications including postoperative pain, discomfort,or swelling.

    These symptoms will be evaluated after 1, 2, 3,5 and 7 days by contacting the patient on the phone and at follow up visits at 3, 6, and 12 months.

  3. Quality of life instruments designed
  4. Semantic scales designed to evaluate patient satisfaction with the treatment received.

Clinical and radiographic assessment of the treated teeth will be recorded. Success will be defined as clinically asymptomatic tooth with no sinus tract or swelling or periapical lesion.

Data will be analysed statistically using appropriate tests based on the distribution of the results.

Study Type

Interventional

Enrollment (Anticipated)

60

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 Contact

Study Contact Backup

Study Locations

  • Jordan
      • Irbid, Jordan, 21110
        • Recruiting
        • Jordan University of Science and Technology
        • Contact:
        • Contact:

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

9 years to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Medically fit patient
  • mature permanent tooth with deep caries
  • diagnosis of irreversible pulpits.
  • tooth is restored with a direct restoration

Exclusion Criteria:

  • immature teeth
  • teeth were hemostasis cannot be achieved after pulpotomy
  • necrotic teeth
  • lack of response to cold test

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Root canal treatment group
This group will receive complete root canal therapy
Procedure: Non surgical root canal treatment
Complete root canal treatment will be performed followed by direct restoration
Active Comparator: Pulpotomy group
This group will receive full pulpotomy
Procedure: Pulpotomy
Full pulpotomy followed by direct restoration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post operative pain level on numerical pain scale
Time Frame: 7 days
Pain level after treatment will be assessed on a numerical scale from 0-10 where is zero refer to no pain and 10 is the most sever pain.
7 days
Post operative pain level on visual analogue scale
Time Frame: 7 days
Pain level after treatment will be assessed on a visual analogy scale from 0-10, where is zero refer to no pain and 10 is the most sever pain.
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical success
Time Frame: 6, 12, 24, 48 months
The tooth should be pain free, no sinus tract, no tenderness to palpation and no swelling. As measured by clinical examination
6, 12, 24, 48 months
Radiographic success
Time Frame: 6, 12, 24, 48 months
Periapical x-ray will be taken it should show no bone lesions or root resorption
6, 12, 24, 48 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
The quality of life questionnaire
Time Frame: 6,12, 24, 48 months
A questionnaire validated previously by Dugas et al 2002 will be used to assess Quality of life
6,12, 24, 48 months

Collaborators and Investigators

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

Sponsor

Jordan University of Science and Technology

Investigators

  • Principal Investigator: Nessrin Taha, PhD, Jordan University of Science and Technology

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)

April 1, 2019

Primary Completion (Anticipated)

September 20, 2024

Study Completion (Anticipated)

January 1, 2025

Study Registration Dates

First Submitted

November 23, 2021

First Submitted That Met QC Criteria

March 14, 2022

First Posted (Actual)

March 15, 2022

Study Record Updates

Last Update Posted (Actual)

October 26, 2022

Last Update Submitted That Met QC Criteria

October 24, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 375/2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

After collection of data and publication , data might be made available for the benefit off other researchers

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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