Conservative Pulp Therapy of Primary Molars Using TheraCAL

Indirect Pulp Capping, Direct Pulp Capping, Partial Pulpotomy, Pulpotomy of Primary Molars Using TheraCal; A Clinical Trial

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04167943

Enrollment

216

Registered

2019-11-19

Start date

2019-11-25

Completion date

2021-09-01

Last updated

2022-06-14

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

Conditions

Reversible Pulpitis

Keywords

indirect pulp capping, direct pulp capping, partial pulpotomy, pulpotomy, TheraCal, primary molars

Brief summary

The study is a clinical trial that assesses the clinical and radiographic success rates of 3 conservative pulp therapy treatments in primary molars compared to conventional pulpotomy using a bioactive dual cured calcium silicate cement (TheraCAL PT).

Detailed description

Participating Children will be recruited from the outpatient's clinic of pediatric dentistry department , Faculty of Dentistry Ain Shams University and will be allocated to one of the following groups; Indirect pulp capping, direct pulp capping, partial pulpotomy or pulpotomy. TheraCAL PT, a dual cured tricalcium silicate cement will be used in all groups as the pulp capping material. Children will be followed every 6 months for a period of 1 year to evaluate clinical and radiographic success.

Interventions

DRUGDual cured resin modified tricalcium silicate cement

A resin based, dual cured tricalcium silicate based cement

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

4 Years to 6 Years

Healthy volunteers

Yes

Inclusion criteria

* Four to six years old healthy children * Cooperative (frankle scale + and ++) * With at least one vital and restorable primary molar with deep caries.

Exclusion criteria

* History of spontaneous pain, swelling, or sinus tract * Pathological mobility * pain on percussion * Furcation or periapical radiolucency * Internal or external pathological root resorption * Widening of periodontal membrane space * Discontinuity of lamina dura.

Design outcomes

Primary

Measure	Time frame	Description
Changes in Visual and tactile clinical examination	every 6 months	Teeth will examined for any clinical signs of irreversible pulpitis or pulp necrosis

Secondary

Measure	Time frame	Description
Change in Dental Periapical Radiographic examination	every 6 months	Teeth will be examined for any radiographic signs of pulp necrosis

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026