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Pulp Capping in Primary Molars Using TheraCal (LC)

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05167123
Enrollment
40
Registered
2021-12-22
Start date
2019-09-01
Completion date
2021-12-15
Last updated
2023-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

IPC , DPC

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.

Interventions

DRUGLight 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

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

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

Intervention model description

Simple parallel randomization was performed by using computerized random numbers

Eligibility

Sex/Gender
ALL
Age
4 Years to 7 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
recording signs and symptoms through clinical examinationone year follow-upAll 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

MeasureTime frameDescription
recording pathological Changes in Radiographic examinationone year follow-upAll 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 materialone year follow-upClinical 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 .

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026