Pulp Capping in Primary Molars Using TheraCal (LC)

Ain Shams University40 enrolled

Overview

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)).

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

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

Interventions

Light cured tri-calcium silicate base materialDRUG

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

Eligibility

Sex: ALLMin age: 4 YearsMax age: 7 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (3)

Ain Shams University Faculy of Dentistry

Cairo, Egypt

Department of pediatric dentistry - Ain Shams University

Cairo, Egypt

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

Cairo, Egypt

Outcomes

Primary Outcomes

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.

Time frame: one year follow-up

Secondary Outcomes

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 .

Time frame: one year follow-up

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 .

Time frame: one year follow-up

Data from ClinicalTrials.gov

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