Pulp Capping in Primary Molars Using TheraCal (LC)

NCT ID: NCT05167123

Last Updated: 2023-02-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-01

Study Completion Date

2021-12-15

Brief Summary

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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

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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.

Conditions

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Deep Caries Indirect Pulp Capping Direct Pulp Capping Reversible Pulpitis Decayed Teeth Vital Pulp Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Simple parallel randomization was performed by using computerized random numbers
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
The participants and the outcome assessor were blinded. The primary investigator blinding was impossible

Study Groups

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Indirect Pulp Capping

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

Group Type EXPERIMENTAL

Light cured tri-calcium silicate base material

Intervention Type DRUG

TheraCal (LC) (BISCO Inc., Schamburg, IL, USA) was introduced in (2011), are available commercially as flowable cement applicable via syringe

Direct Pulp Capping

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

Group Type EXPERIMENTAL

Light cured tri-calcium silicate base material

Intervention Type DRUG

TheraCal (LC) (BISCO Inc., Schamburg, IL, USA) was introduced in (2011), are available commercially as flowable cement applicable via syringe

Interventions

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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

Intervention Type DRUG

Other Intervention Names

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TheraCal (LC)

Eligibility Criteria

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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
Minimum Eligible Age

4 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Yomna Hussein Moselhy

Principle investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yomna Hussein Moselhy, M.Sc.

Role: PRINCIPAL_INVESTIGATOR

Ain Shams University

Locations

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Ain Shams University Faculy of Dentistry

Cairo, , Egypt

Site Status

Department of pediatric dentistry - Ain Shams University

Cairo, , Egypt

Site Status

Outpatient Clinic of the Department of Pediatric Dentistry, Ain Shams University

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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FDASU-RECIM041919

Identifier Type: -

Identifier Source: org_study_id

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