Light Cured Resin Modified Calcium Silicate Versus Light Cured Calcium Hydroxide in Indirect Pulp Treatment of Primary Molars

Clinical and Radiographic Evaluation of Light Cured Resin Modified Calcium Silicate Versus Light Cured Calcium Hydroxide in Indirect Pulp Treatment of Primary Molars

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03791255

Enrollment

Registered

2019-01-02

Start date

2019-02-28

Completion date

2021-02-28

Last updated

2019-01-15

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

Conditions

Deep Carious Lesion, Indirect Pulp Treatment

Keywords

resin modified calcium silicate, indirect pulp treatment, primary molars

Brief summary

The objective of this study is to explore if light cured resin modified Calcium silicate could result in better clinical and radiographic success if compared to light cured Calcium hydroxide when used in indirect pulp capping treatment in primary molars.

Detailed description

To evaluate clinical and radiographic success of resin modified calcium silicate in comparison to light cured calcium hydroxide as indirect pulp capping materials in primary molars. P: Children aged (4-7 years) with deep carious lesions in lower primary second molars indicated for indirect pulp treatment. I: Indirect pulp treatment using light cured resin modified Calcium Silicate (TheraCal). C: Indirect pulp treatment using light cured Calcium Hydroxide. O: clinical and radiographic success.

Interventions

DRUGCalcium silicate liner

new light-cured resin-modified calcium silicate-filled base/ liner material designed for direct and indirect pulp capping

DRUGCalcium hydroxide liner

Calcium hydroxide is the gold standard for pulp capping, allows for the formation of a reparative dentin bridge

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

4 Years to 7 Years

Healthy volunteers

Yes

Inclusion criteria

1. Medically free children. 2. Age range from 4-7 years. 3. Presence of lower second primary molars with deep carious occlusal lesion. 4. No history of spontaneous pain (reversible pulpitis). 5. Clinically: Absence of swelling, sinus, fistula, pain on percussion and tooth mobility. 6. Radiographically: Absence of radiolucent lesions at furcation or periapical region and absence of internal or external root resorption.

Exclusion criteria

1. Uncooperative children. 2. Any unmet previous criterion.

Design outcomes

Primary

Measure	Time frame	Description
Postoperative pain	1 month	Pain questionnaire (binary yes/no)

Secondary

Measure	Time frame	Description
Sinus or fistula	1 month	Visual examination by the operator (binary yes/no)
Tooth mobility	1 month	back of the mirror to check mobility (binary yes/no)
pain on percussion	1 month	back of the mirror to check pain on percussion (binary yes/no)
Swelling	1 month	Visual examination by the operator (binary yes/no)
widening in the periodontal membrane space	1 month	(binary yes/no)
presence of internal or external root resorption	1 month	(binary yes/no)
Occurrence of radiolucent lesions at furcation or periapical region	1 months	(binary yes/no)

Outcome results

None listed

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