Pulp Capping in Primary Molars Using TheraCal (LC)

December 7, 2021 updated by: Yomna Hussein Moselhy, Ain Shams University

Radiographic and Clinical Evaluation of Indirect and Direct Pulp Capping in Primary Molars Using TheraCal (LC)

A randomized clinical trial that aims to evaluate clinical and radiographic success rates of indirect pulp capping and direct pulp capping in primary molars with reversible pulpitis using a light-cured tri-calcium silicate base material (TheraCal (LC)).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Participating primary molars will be randomly allocated to one of the following groups: Indirect pulp capping group or Direct pulp capping group. A light-cured tri-calcium silicate base material (TheraCal (LC) ) will be used in the two groups as a dressing material. Patients will be recruited from the outpatient clinic of the pediatric dentistry department, Faculty of Dentistry Ain Shams University. The participant will be recalled for follow-up assessments at 3, 6,9, and 12 months.

Study Type

Interventional

Enrollment (Anticipated)

40

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 Contact

Study Contact Backup

Study Locations

  • Egypt
      • Cairo, Egypt, 02112
        • Recruiting
        • Ain Shams University Faculy of Dentistry
        • Contact:
      • Cairo, Egypt, 02112
        • Recruiting
        • Department of pediatric dentistry - Ain Shams University
        • Contact:
        • Contact:
      • Cairo, Egypt, 11566
        • Recruiting
        • Outpatient Clinic of the Department of Pediatric Dentistry, Ain Shams University
        • Contact:
        • Principal Investigator:
          • Yomna Hussein Moselhy, M.Sc.

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 7 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age: 4-7 years.
  2. Free medical history.
  3. Complete physical and mental health.
  4. Patient cooperation
  5. restorable mandibular primary molars

Exclusion Criteria:

  1. Clinical symptoms or irreversible pulpitis as (spontaneous pain, throbbing pain)
  2. Soft tissue swelling, draining fistula or sinus tracts.
  3. Tenderness to percussion.
  4. Pathological Tooth mobility.
  5. Widening of periodontal membrane space

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: Indirect Pulp Capping
TheraCal (LC) will be applied to affected dentin after excavation of infected dentin
Drug: Light cured tri-calcium silicate base material
TheraCal (LC) (BISCO Inc., Schamburg, IL, USA) was introduced in (2011), are available commercially as flowable cement applicable via syringe
Other Names:
  • TheraCal (LC)
Experimental: Direct Pulp Capping
TheraCal (LC) will be applied to pinpoint pulp exposures (less than 1mm ) in vital pulps surrounded by sound dentin.
Drug: Light cured tri-calcium silicate base material
TheraCal (LC) (BISCO Inc., Schamburg, IL, USA) was introduced in (2011), are available commercially as flowable cement applicable via syringe
Other Names:
  • TheraCal (LC)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
recording signs and symptoms through clinical examination
Time Frame: one year follow-up
All the primary molars participating in this study will be examined clinically under the illumination of dental unit, percussion and palpation test will be performed to ensure absence of any sign and symptoms of irreversible pulpitis or nectrotic pulp during follow -up period.
one year follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
recording pathological Changes in Radiographic examination
Time Frame: one year follow-up
All the primary molars participating in this study will be examined radiographically every (3,6,9,12 months) to ensure the absence of any pathological changes .
one year follow-up
Evaluation of TheraCal (LC) as a pulp capping material
Time Frame: one year follow-up
Clinical and radiographic examination will be done to each tooth participating in this study to evaluate the efficiency of TheraCal (LC) when used as a pulp capping material in primary molars .
one year follow-up

Collaborators and Investigators

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

Sponsor

Ain Shams University

Investigators

  • Principal Investigator: Yomna Hussein Moselhy, M.Sc., 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)

September 1, 2019

Primary Completion (Actual)

November 30, 2021

Study Completion (Anticipated)

December 15, 2021

Study Registration Dates

First Submitted

September 28, 2021

First Submitted That Met QC Criteria

December 7, 2021

First Posted (Actual)

December 22, 2021

Study Record Updates

Last Update Posted (Actual)

December 22, 2021

Last Update Submitted That Met QC Criteria

December 7, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FDASU-RECIM041919

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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