Assessment of Pain and Treatment Success After VPT Versus RCT in Mature Permanent Mandibular Molars With SIP: A RCT

February 15, 2023 updated by: Amany Ibrahiem Ahmed Mohamed, Cairo University

Assessment of Postoperative Pain and Treatment Success After Vital Pulp Therapy Versus Root Canal Treatment in Mature Permanent Mandibular Molars With Irreversible Pulpitis: A Randomized Controlled Trial

Assessment of postoperative pain and treatment success after vital pulp therapy versus root canal treatment in mandibular molar with signs and symptoms of irreversible pulpitis. the null hypothesis, there is no difference will be observed in the pain level and treatment success between two treatments.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

After proper clinical and radiographic examination. Teeth will be anesthetized and isolated using a rubber dam. The operative field will be disinfected. Total caries removal will be done from outside making margin caries free to inside. the new diamond bur will be used to remove the last layer and exposed the pulp tissue. Exposed pulp will be inspected under a dental operating microscope and hemostasis will be obtained. The teeth will be randomized into 2 intervention groups (VPT or RCT). Treatment will be finalized, and teeth will be restored with resin-modified glass ionomer followed by composite resin at the same appointment. Ibuprofen 400mg will be prescribed to the patient if needed. Patients will be asked to record postoperative pain after treatment on the pain score sheet.

Study Type

Interventional

Enrollment (Anticipated)

44

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

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

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Systemically healthy patients.
  • Patient's age range more than 15 years.
  • Mature permanent mandibular molars with deep caries.
  • Clinical diagnosis of symptomatic irreversible pulpitis.
  • Teeth with no need for the post.
  • Healthy periodontium and mobility within normal limits.
  • Patients who can understand the pain scale and can sign the informed consent

Exclusion Criteria:

  • Teeth with a negative response to vitality testing.
  • Teeth with furcal bone loss.
  • Teeth with sinus tract
  • Teeth with swelling.
  • Teeth with a non-restorable crown.
  • Teeth with immature roots.
  • Teeth with no pulp exposure even after caries excavation.
  • History of analgesic intake in the previous week.
  • History of antibiotic intake in the previous month.
  • Insufficient bleeding after pulp exposure suggestive of partial necrosis of the pulp.
  • Inability to control bleeding within 10 min.
  • Radiographic evidence of external or internal root resorption vertical root fracture, perforation, calcification.

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
after access cavity preparation, the working length will be determined. chemo-mechanical preparation will be done, and teeth will be obturated. final restoration will be placed.
Procedure: Root canal treatment
after access cavity preparation, the working length will be determined. chemo-mechanical preparation will be done, and teeth will be obturated. final restoration will be placed.
Other Names:
  • RCT, Full pulpectomy
Experimental: Vital pulp therapy
exposed pulp will be capped with 3 mm calcium silicate material
Procedure: Vital pulp therapy
exposed pulp will be capped with 3 mm calcium silicate material
Other Names:
  • pulpotomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pain
Time Frame: at 6 hours postoperative
postoperative pain will be recorded by patient using NRS
at 6 hours postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intensity of postoperative pain
Time Frame: at 24, 48 hours and 7 days
postoperative pain will be recorded by patient using NRS
at 24, 48 hours and 7 days
Treatment success
Time Frame: at 3,6,12 months
clinical and radiographic success
at 3,6,12 months

Collaborators and Investigators

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

Sponsor

Cairo University

Investigators

  • Study Director: Ahmed S Elsheshtawy, Lecturer, Department of Endodontics, Faculty of Dentistry, Cairo university.

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 (Anticipated)

February 26, 2023

Primary Completion (Anticipated)

July 26, 2023

Study Completion (Anticipated)

June 26, 2024

Study Registration Dates

First Submitted

December 28, 2022

First Submitted That Met QC Criteria

December 28, 2022

First Posted (Actual)

January 12, 2023

Study Record Updates

Last Update Posted (Actual)

February 16, 2023

Last Update Submitted That Met QC Criteria

February 15, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 28/12/2022

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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