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

NCT ID: NCT05956613

Last Updated: 2024-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-01

Study Completion Date

2023-10-22

Brief Summary

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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.

Detailed Description

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Conditions

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Endodontic Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Control: conventional root canal treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Test: partial pulpotomy

Partial pulpotomy using bioceramic putty

Group Type OTHER

Partial pulpotomy

Intervention Type PROCEDURE

Use of newly introduced bioceramic putty in partial pulpotomy

Interventions

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Partial pulpotomy

Use of newly introduced bioceramic putty in partial pulpotomy

Intervention Type PROCEDURE

Eligibility Criteria

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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.

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.
Minimum Eligible Age

9 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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October 6 University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Omaia Ahmed Salah

Lecturer of Endodontics

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of Dentistry, October 6 University

Giza, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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RECO6U/27-2023

Identifier Type: -

Identifier Source: org_study_id

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