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Pulp Capping in Primary Molars Using TheraCal (LC)

Primary Purpose

Deep Caries, Indirect Pulp Capping, Direct Pulp Capping

Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Light cured tri-calcium silicate base material
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Deep Caries focused on measuring IPC , DPC

Eligibility Criteria

4 Years - 7 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Ain Shams University Faculy of Dentistry
  • Department of pediatric dentistry - Ain Shams University
  • Outpatient Clinic of the Department of Pediatric Dentistry, Ain Shams University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Indirect Pulp Capping

Direct Pulp Capping

Arm Description

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

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

Outcomes

Primary Outcome Measures

recording signs and symptoms through clinical examination
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 Outcome Measures

recording pathological Changes in Radiographic examination
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 .
Evaluation of TheraCal (LC) as a pulp capping material
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 .

Full Information

First Posted
September 28, 2021
Last Updated
February 2, 2023
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT05167123
Brief Title
Pulp Capping in Primary Molars Using TheraCal (LC)
Official Title
Radiographic and Clinical Evaluation of Indirect and Direct Pulp Capping in Primary Molars Using TheraCal (LC)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
November 30, 2021 (Actual)
Study Completion Date
December 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deep Caries, Indirect Pulp Capping, Direct Pulp Capping, Reversible Pulpitis, Decayed Teeth, Vital Pulp Therapy
Keywords
IPC , DPC

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Simple parallel randomization was performed by using computerized random numbers
Masking
ParticipantOutcomes Assessor
Masking Description
The participants and the outcome assessor were blinded. The primary investigator blinding was impossible
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Indirect Pulp Capping
Arm Type
Experimental
Arm Description
TheraCal (LC) will be applied to affected dentin after excavation of infected dentin
Arm Title
Direct Pulp Capping
Arm Type
Experimental
Arm Description
TheraCal (LC) will be applied to pinpoint pulp exposures (less than 1mm ) in vital pulps surrounded by sound dentin.
Intervention Type
Drug
Intervention Name(s)
Light cured tri-calcium silicate base material
Other Intervention Name(s)
TheraCal (LC)
Intervention Description
TheraCal (LC) (BISCO Inc., Schamburg, IL, USA) was introduced in (2011), are available commercially as flowable cement applicable via syringe
Primary Outcome Measure Information:
Title
recording signs and symptoms through clinical examination
Description
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.
Time Frame
one year follow-up
Secondary Outcome Measure Information:
Title
recording pathological Changes in Radiographic examination
Description
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 .
Time Frame
one year follow-up
Title
Evaluation of TheraCal (LC) as a pulp capping material
Description
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 .
Time Frame
one year follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yomna Hussein Moselhy, M.Sc.
Organizational Affiliation
Ain Shams University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ain Shams University Faculy of Dentistry
City
Cairo
ZIP/Postal Code
02112
Country
Egypt
Facility Name
Department of pediatric dentistry - Ain Shams University
City
Cairo
ZIP/Postal Code
02112
Country
Egypt
Facility Name
Outpatient Clinic of the Department of Pediatric Dentistry, Ain Shams University
City
Cairo
ZIP/Postal Code
11566
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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Pulp Capping in Primary Molars Using TheraCal (LC)

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