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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-28

Study Completion Date

2021-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Pulp Capping in Primary Molars Using TheraCal (LC)

NCT05167123

Deep Caries Indirect Pulp Capping Direct Pulp Capping +3 more

COMPLETED PHASE4

Indirect Pulp Treatment in Primary Molars

NCT03770871

Dental Caries

COMPLETED PHASE4

Conservative Pulp Therapy of Primary Molars Using TheraCAL

NCT04167943

Reversible Pulpitis

COMPLETED PHASE3

Antibacterial Effect of Light-activated Calcium Silicate Versus Light-activated Calcium Hydroxide

NCT03214770

Dental Caries Extending Into Dentin

UNKNOWN PHASE1

Calcium Hydroxide Versus Premixed Bioceramic Putty in Direct Pulp Capping of Primary Molars

NCT05496257

Direct Pulp Capping

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Deep Carious Lesion Indirect Pulp Treatment

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Resin Modified Calcium Silicate

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

Group Type EXPERIMENTAL

Calcium silicate liner

Intervention Type DRUG

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

Light Cured Calcium Hydroxide

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

Group Type ACTIVE_COMPARATOR

Calcium hydroxide liner

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Calcium silicate liner

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

Intervention Type DRUG

Calcium hydroxide liner

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.