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

Cairo University (CU)

Status and phase: Unknown; Phase 4

Conditions: Indirect Pulp Treatment; Deep Carious Lesion

Treatments: Drug: Calcium silicate liner; Drug: Calcium hydroxide liner

Study type: Interventional

Funder types: Other

Identifiers

NCT03791255

Indirect pulp primary molars

Details and patient eligibility

About

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.

Full 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.

Enrollment: 46 estimated patients

Sex: All

Ages: 4 to 7 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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46 participants in 2 patient groups

Resin Modified Calcium Silicate

Experimental group

Description:

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

Treatment:

Drug: Calcium silicate liner

Light Cured Calcium Hydroxide

Active Comparator group

Description:

gold standard for pulp capping, It allows for the formation of a reparative dentine bridge through cellular differentiation, extracellular matrix secretion and subsequent mineralization.

Treatment:

Drug: Calcium hydroxide liner