Clinical and Radiographic Evaluation in Pulpotomy of Primary Molars Using Protooth Vs. MTA

August 4, 2021 updated by: Nashwa Ossama Ahmed Elshaer, Cairo University

Clinical and Radiographic Evaluation in Pulpotomy of Primary Molars Using Novel Fast-setting Calcium Silicate Cement (Protooth) Versus Mineral Trioxide Aggregate (MTA): A Pilot Study

The aim of the study is to evaluate the clinical and radiographic success in pulpotomy using novel fast-setting calcium silicate cement (Protooth) versus MTA in exposed primary molars.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 8 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Complete physical and mental health, with no confounding history of systemic disease and/or use of special local or systemic drugs
  • No allergic reactions recorded in patient history
  • Having primary molar teeth in one jaw, having deep caries and vital pulp.
  • No history of spontaneous pain, pathologic mobility, draining sinus tract, redness or swelling of vestibule

  • Normal gingival and periodontal condition, with no sensitivity to vestibular palpation, and no pain on percussion test

    • Radiographic criteria:
  • No sign of radiolucency in periapical or furcation area
  • No widening of PDL space or loss of lamina dura continuity
  • No evidence of internal/external pathologic root resorption

Exclusion Criteria:

  • Lack of informed consent by the child patient's parent
  • Lack of informed consent by the child patient's parent
  • Unable to attend follow-up visits.
  • Refusal of participation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Novel fast setting calcium silicate ( Protooth)
In the form of powder and liquid to be mixed together to form paste.
Drug: Novel fast-setting calcium silicate cement (Protooth)
In form of power and liquid to be mixed together to form a paste.
Other Names:
  • mineral trioxide aggregate (MTA )
Experimental: MTA
In form of powder to be mixed with saline to form paste.
Drug: Novel fast-setting calcium silicate cement (Protooth)
In form of power and liquid to be mixed together to form a paste.
Other Names:
  • mineral trioxide aggregate (MTA )

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical evaluation including postoperative pain , pain on percussion or palpation will be measured using VAS
Time Frame: 12 months

Post-operative pain following pulpotomy treatment will be measured.

A pain chart using visual analogue scale (VAS) will be used to record the patients' pain levels. The VAS (0-10 scale) consists of a line anchored by two extremes "No pain" and "the worst pain". Patients will be asked to choose the mark that represented their level of pain from 0 to 10. Pain level will be assigned as follow:

0, "no pain" 1-3, "mild pain" 4-6, "moderate pain" 7-10, "severe pain" Using the VAS chart, the patient will choose and record the most appropriate pain rating according to the pain intensity endured.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiographic evaluation following the Pulpotomy treatment will be measured
Time Frame: 12 months
Binary assessment of the radiographs taken after the treatment ( if there is any radiolucent or widening in the lamina sure nor evidence of internal/external pathologic root resorption)
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 1, 2021

Primary Completion (Anticipated)

October 22, 2022

Study Completion (Anticipated)

November 1, 2022

Study Registration Dates

First Submitted

January 12, 2021

First Submitted That Met QC Criteria

January 13, 2021

First Posted (Actual)

January 14, 2021

Study Record Updates

Last Update Posted (Actual)

August 5, 2021

Last Update Submitted That Met QC Criteria

August 4, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pedo193

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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