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Clinical Trials/NCT05167123
NCT05167123
Completed
Phase 4

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

Ain Shams University3 sites in 1 country40 target enrollmentSeptember 1, 2019

Overview

Phase
Phase 4
Intervention
Light cured tri-calcium silicate base material
Conditions
Deep Caries
Sponsor
Ain Shams University
Enrollment
40
Locations
3
Primary Endpoint
recording signs and symptoms through clinical examination
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

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)).

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2019
End Date
December 15, 2021
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Yomna Hussein Moselhy

Principle investigator

Ain Shams University

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Arms & Interventions

Indirect Pulp Capping

TheraCal (LC) will be applied to affected dentin after excavation of infected dentin

Intervention: Light cured tri-calcium silicate base material

Direct Pulp Capping

TheraCal (LC) will be applied to pinpoint pulp exposures (less than 1mm ) in vital pulps surrounded by sound dentin.

Intervention: Light cured tri-calcium silicate base material

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • recording pathological Changes in Radiographic examination(one year follow-up)
  • Evaluation of TheraCal (LC) as a pulp capping material(one year follow-up)

Study Sites (3)

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