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

Sponsor

October 6 University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05956613

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

41.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Endodontic Disease	Procedure: Partial pulpotomy	Early Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

84 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Post Operative Pain of Partial Pulpotomy Using a Newly Introduced Bioceramic Material in Young Patients With Symptomatic Irreversible Pulpitis: A Double Blind Randomized Clinical Trial.

Anticipated Study Start Date :

Aug 1, 2023

Anticipated Primary Completion Date :

Sep 1, 2023

Anticipated Study Completion Date :

Oct 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control: conventional root canal treatment
Other: Test: partial pulpotomy Partial pulpotomy using bioceramic putty	Procedure: Partial pulpotomy Use of newly introduced bioceramic putty in partial pulpotomy

Arm

Intervention/Treatment

No Intervention: Control: conventional root canal treatment

Other: Test: partial pulpotomy

Partial pulpotomy using bioceramic putty

Procedure: Partial pulpotomy

Use of newly introduced bioceramic putty in partial pulpotomy

Outcome Measures

Primary Outcome Measures

Post operative pain [after 24 hours]
Measure intensity of post operative pain using visual analogue scale (VAS)
Post operative pain [after 48 hours]
Measure intensity of post operative pain using visual analogue scale (VAS)
Post operative pain [After 72 hours]
Measure intensity of post operative pain using visual analogue scale (VAS)

Eligibility Criteria

Criteria

Ages Eligible for Study:

9 Years to 14 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion criteria :
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.
Exclusion Criteria:
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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Dentistry, October 6 University	Giza		Egypt	12573

Sponsors and Collaborators

October 6 University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mohamed Omaia Ahmed Salah, Lecturer of Endodontics, October 6 University

ClinicalTrials.gov Identifier:

NCT05956613

Other Study ID Numbers:

RECO6U/27-2023

First Posted:

Jul 21, 2023

Last Update Posted:

Jul 21, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Mohamed Omaia Ahmed Salah, Lecturer of Endodontics, October 6 University

bioceramic material, pulpitis, partial pulpotomy

Additional relevant MeSH terms:

Pulpitis

Dental Pulp Diseases

Pain, Postoperative

Study Results

No Results Posted as of Jul 21, 2023