Theracal Pulpotomy in Primary Molars

July 11, 2020 updated by: Mariem Wassel, Ain Shams University

Theracal Versus Formocresol Pulpotomy in Primary Molars

Light cured silicate based cement (theracal LC) pulpotomy was compared to formocresol pulpotomy in primary molars.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

sixty primary molars were either treated with Theracal LC or formocresol pulpotomy. Teeth were followed up clinicaly and radiographically for 12 months.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

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

Study Locations

  • Egypt
      • Cairo, Egypt, 1156
        • Faculty of Dentistry, Ain Shams University

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

2 years to 5 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • healthy, cooperative children
  • mandibular primary molars with vital pulp exposures

Exclusion Criteria:

  • clinical or radiographic evidence of irreversible pulpitis
  • physiological root resorption

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
Experimental: Theracal LC
Theracal LC was used as a medicament to cover root stumps of asymptomatic thirty primary molars with vital pulp exposures. Teeth were followed up clinically and radiographically for 12 months.
Drug: Theracal LC
pulpotomy
Active Comparator: Formocresol
Formocresol was used as a medicament to cover root stumps of asymptomatic thirty primary molars with vital pulp exposures. Teeth were followed up clinically and radiographically for 12 months.
Drug: Formocresol
Pulpotomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Examination
Time Frame: 12 months
Number of participants with tooth mobility, restoration loss, gingival swelling/fistula, pain on percussion.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiographic Examination
Time Frame: 12 months
Number of participants showing teeth with inter-radicular bone resorption, periapical bone resorption, internal root resorption, external root resorption, widening of periodontal ligament space.
12 months

Collaborators and Investigators

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

Sponsor

Ain Shams 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 (Actual)

December 1, 2017

Primary Completion (Actual)

March 17, 2018

Study Completion (Actual)

March 30, 2019

Study Registration Dates

First Submitted

May 17, 2020

First Submitted That Met QC Criteria

May 17, 2020

First Posted (Actual)

May 21, 2020

Study Record Updates

Last Update Posted (Actual)

July 29, 2020

Last Update Submitted That Met QC Criteria

July 11, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • FDASU-Rec ID 101612

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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