Outcome of Pulpotomy Versus Root Canal Therapy

Sponsor

Jordan University of Science and Technology (Other)

Overall Status

Recruiting

CT.gov ID

NCT05279781

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Caries Pulpitis - Irreversible	Procedure: Non surgical root canal treatment Procedure: Pulpotomy	N/A

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:

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

Quality of life instruments designed
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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Two groups. One will receive root canal treatment t and the other will receive pulpotomy.Two groups. One will receive root canal treatment t and the other will receive pulpotomy.

Masking:

Single (Participant)

Masking Description:

Participant will not be informed whether complete pulp removal or partial treatment was done. Operator and investigator cannot be blinded due to differences in the procedure and it will be evident on the radiographs, so it cannot be masked during radiographic evaluation.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 1, 2019

Anticipated Primary Completion Date :

May 5, 2022

Anticipated Study Completion Date :

Jan 1, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Post operative pain level on numerical pain scale [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.
Post operative pain level on visual analogue scale [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.

Secondary Outcome Measures

Clinical success [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
Radiographic success [6, 12, 24, 48 months]
Periapical x-ray will be taken it should show no bone lesions or root resorption

Other Outcome Measures

The quality of life questionnaire [6,12, 24, 48 months]
A questionnaire validated previously by Dugas et al 2002 will be used to assess Quality of life

Eligibility Criteria

Criteria

Ages Eligible for Study:

9 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jordan University of science and technology	Irbid		Jordan	21110

Sponsors and Collaborators

Jordan University of Science and Technology

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jordan University of Science and Technology

ClinicalTrials.gov Identifier:

NCT05279781

Other Study ID Numbers:

375/2019

First Posted:

Mar 15, 2022

Last Update Posted:

Mar 15, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pulpitis

Study Results

No Results Posted as of Mar 15, 2022