Post Operative Pain of Partial Pulpotomy Using a Bioceramic Material in Patients With Symptomatic Irreversible Pulpitis

NCT05956613 | Completed Early Phase 1

• 1 other identifier: RECO6U/27-2023
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to assess post-operative pain of partial pulpotomy using a newly introduced Bioceramic material in young patients with symptomatic irreversible pulpitis at 24, 48, 72 hours postoperatively using visual analogue scale (VAS). The main question\[s\] it aims to answer are: • In patients with symptomatic irreversible pulpitis does the use of bioceramic material in partial pulpotomy decrease amount of post operative pain in comparison to conventional root canal treatment? Participants will record the intensity of pain at 24,48, 72 hours postoperatively.

Conditions

Endodontic Disease

Keywords

bioceramic material, pulpitis, partial pulpotomy

Outcome Measures

Primary Outcomes (3)

• Post operative pain

  Measure intensity of post operative pain using visual analogue scale (VAS)

  after 24 hours

• Post operative pain

  Measure intensity of post operative pain using visual analogue scale (VAS)

  after 48 hours

• Post operative pain

  Measure intensity of post operative pain using visual analogue scale (VAS)

  After 72 hours

Study Arms (2)

Control: conventional root canal treatment

NO INTERVENTION

Test: partial pulpotomy

OTHER

Partial pulpotomy using bioceramic putty

Procedure: Partial pulpotomy

Interventions

Partial pulpotomy PROCEDURE

Use of newly introduced bioceramic putty in partial pulpotomy

Test: partial pulpotomy

Eligibility Criteria

• Age: 9 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Subject's age between 9-14 years.
• Both male and female subjects.
• Medically free and healthy subjects.
• Mandibular molar teeth.
• Teeth with symptomatic irreversible pulpitis.
• Teeth with mature closed apices.

You may not qualify if:

• Teeth with acute dentoalveolar abscess.
• Subjects having more than one tooth that require root canal treatment.
• Subjects that have taken analgesic, anti-inflammatory or antibiotic drugs during the 10 days prior to the start of treatment.
• Subjects with systemic diseases who have endocrine diseases, Infectious diseases or Psychological disturbance.
• Teeth with periodontal disease or pulp calcification.
• Subjects taking chronic pain medications.

Sponsors & Collaborators

• October 6 University: lead

Study Sites (1)

Faculty of Dentistry, October 6 University

Giza, 12573, Egypt

Location

MeSH Terms

Conditions

Dental Pulp Diseases; Pulpitis

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Endodontics

Study Record Dates

• First Submitted: July 7, 2023
• First Posted: July 21, 2023
• Study Start: August 1, 2023
• Primary Completion: October 1, 2023
• Study Completion: October 22, 2023
• Last Updated: May 14, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)