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Pulpotomy vs Root Canal Treatment for Teeth With Symptomatic Irreversible Pulpitis

Sponsor
British University In Egypt (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05726357
Collaborator
(none)
380
Enrollment
2
Arms
21
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

high-quality evidence is needed to add to current knowledge and also assess the long-term outcomes for full/complete pulpotomy after carious pulpal exposure in patients with signs and symptoms indicative of irreversible pulpitis

Condition or Disease Intervention/Treatment Phase
  • Procedure: vital pulp therapy
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
380 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Pulpotomy vs Root Canal Treatment for Teeth With Symptomatic Irreversible Pulpitis: A Randomised Control Trial
Anticipated Study Start Date :
Mar 1, 2023
Anticipated Primary Completion Date :
Mar 31, 2024
Anticipated Study Completion Date :
Nov 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: standard root canal treatment

standard root canal treatment

Procedure: vital pulp therapy
removal of the coronal pulp followed by placing a biocompatible material to preserve the vitality of the radicular pulp
Active Comparator: Pulpotomy

vital pulp therapy

Procedure: vital pulp therapy
removal of the coronal pulp followed by placing a biocompatible material to preserve the vitality of the radicular pulp

Outcome Measures

Primary Outcome Measures

  1. pain score [day 3 post treatment]

    score by a numeric rating scale from 1(minimum pain) to 100 (maximum pain)

Secondary Outcome Measures

  1. pain score [6 months post treatment]

    score by a numeric rating scale from 1(minimum pain) to 100 (maximum pain)

Eligibility Criteria

Criteria

Ages Eligible for Study:
12 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • a mature permanent tooth

  • symptoms indicative of IRP

  • responsive to cold and EPT sensibility testing

  • restorable and can be adequately isolated during treatment

  • One tooth (molar or premolar) per patient.

Exclusion Criteria:

  • active periodontal disease

  • complex medical histories

  • unable to consent

  • pregnant or breast-feeding

  • excessive bleeding that cannot be controlled

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • British University In Egypt

Investigators

  • Principal Investigator: shehabeldin Saber, Professor of Endodontics

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
shehabeldin saber, Professor, British University In Egypt
ClinicalTrials.gov Identifier:
NCT05726357
Other Study ID Numbers:
  • FD BUE REC 22-034
First Posted:
Feb 13, 2023
Last Update Posted:
Feb 13, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by shehabeldin saber, Professor, British University In Egypt
vital pulp therapy
Additional relevant MeSH terms:
Pulpitis

Study Results

No Results Posted as of Feb 13, 2023