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

NCT03214770 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2018-08-01

No results posted yet for this study

Summary

This is a randomized clinical study. 48 subjects with a confirmed diagnosis of deep carious molars without pulpal lesions were randomized to one of two treatments: Patients treated with Light-cured calcium silicate (Theracal) liner, or treated with light-cured calcium Hydroxide (Biner LC) liner. Both two Treatments are with the step-wise excavation Technique.

Treatment will be done at baseline, collecting dentin sample before application of liner material, then patients will be dismissed with Resin-modified Glass Ionomer restoration and recalled after 6 months. Re-entry of tooth required for completing the step-wise excavation technique collecting the second dentin sample after this time interval (6 months) and permanently restore tooth with composite restoration. Dentin samples will be microbiologically analyzed and the results will be statistically calculated.

Conditions

  • Dental Caries Extending Into Dentin

Interventions

DRUG

TheraCal

Biomaterial used for carious lesions reaching to dentin. Material is applied and after 6 month dentin sample collection and the bacterial count by digital colony counter, Agar diffusion test.

DRUG

light-cured calcium hydroxide

Biomaterial used for carious lesions reaching to dentin. Material is applied and after 6 month dentin sample collection and the bacterial count by digital colony counter, Agar diffusion test.

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Principal Investigators

  • Omaima M Safwat, PHD · Professor of Conservative Dentistry, Cairo University

  • Mohsen A Elhassan, PHD · Professor of Conservative Dentistry, Cairo University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-08-10
Primary Completion
2019-09-01
Completion
2019-09-01
FDA Drug
Yes

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03214770 on ClinicalTrials.gov