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

Endodontic Disease Clinical Trial

Official title:

Evaluation of Postoperative Pain After Partial Pulpotomy Versus Full Root Canal Treatment in Managing Young Permanent Molars With Symptomatic Irreversible Pulpitis: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05956613
• Other study ID #: RECO6U/27-2023
• Status: Completed
• Phase: Early Phase 1
• Start date: August 1, 2023
• Est. completion date: October 22, 2023

Study information

• Verified date: May 2024
• Source: October 6 University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 22, 2023
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Years to 14 Years

Eligibility

1. Inclusion criteria :

1. Subject's age between 9-14 years.

2. Both male and female subjects.

3. Medically free and healthy subjects.

4. Mandibular molar teeth.

5. Teeth with symptomatic irreversible pulpitis.

6. Teeth with mature closed apices.

2. Exclusion Criteria:

1. Teeth with acute dentoalveolar abscess.

2. Subjects having more than one tooth that require root canal treatment.

3. Subjects that have taken analgesic, anti-inflammatory or antibiotic drugs during the 10 days prior to the start of treatment.

4. Subjects with systemic diseases who have endocrine diseases, Infectious diseases or Psychological disturbance.

5. Teeth with periodontal disease or pulp calcification.

6. Subjects taking chronic pain medications.

Related Conditions & MeSH terms

• Dental Pulp Diseases
• Endodontic Disease
• Pulpitis

Intervention

Procedure:
• Partial pulpotomy
Use of newly introduced bioceramic putty in partial pulpotomy

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry, October 6 University	Giza

Sponsors (1)

Lead Sponsor	Collaborator
October 6 University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post operative pain	Measure intensity of post operative pain using visual analogue scale (VAS)	after 24 hours
Primary	Post operative pain	Measure intensity of post operative pain using visual analogue scale (VAS)	after 48 hours
Primary	Post operative pain	Measure intensity of post operative pain using visual analogue scale (VAS)	After 72 hours