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

NCT03214770 | Unknown Phase 1 DMC FDA Drug

• 1 other identifier: oper 246
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Bacterial Count

  will be done by Digital colony counter, Agar Diffusion Test The measuring unit of the bacterial count is CFU/ml(colony-forming units per milliliter) for liquids). The first dentin sample will be collected in the baseline time and the second dentin sample after 6 month for each group.

  an average of 6 months

Study Arms (2)

Light-cured calcium silicate

EXPERIMENTAL

This biomaterial calcium silicate is manufactured to have an anti-bacterial effect on micro-organisms within the dentin, thus allowing the inhibition of bacterial growth therefore no caries will progress. Material is injected and light-cured within the dentin and sealed with a restoration.

Drug: TheraCal

Light-cured calcium hydroxide

ACTIVE COMPARATOR

This biomaterial calcium hydroxide is manufactured to have an anti-bacterial effect on micro-organisms within the dentin, thus allowing the inhibition of bacterial growth therefore no caries will progress. Material is injected and light-cured within the dentin and sealed with a restoration.

Drug: light-cured calcium hydroxide

Interventions

TheraCal DRUG

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.

Also known as: light-cured calcium silicate

Light-cured calcium silicate

light-cured calcium hydroxide DRUG

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.

Also known as: Biner LC

Light-cured calcium hydroxide

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Normal adults will be recruited in this study, all the volunteers participated in this experiment will be healthy looking with free medical history.
• Subjects aged between 18-40 years.
• In each patient required one or two deep carious tooth occlusally either upper or lower permanent molars.
• All volunteers must be with good oral hygiene in order to restore with composite restorations.
• Subjects were required to be available for the duration of the study, and to sign an informed consent form

You may not qualify if:

• Subjects with a history of allergy to any of the drugs or chemicals used in the study.
• Subjects with carious anterior tooth are not within the study.
• History of pulp pathology of the teeth which indicates root canal treatment is not included in the study.
• Pregnancy and Lactating mothers.
• Patients with any systematic problems or mental or physical disability.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Hanaa Mohamed Morsy Mohamed

Cairo, New Cairo, Egypt

Location

Related Publications (1)

• Petrou MA, Alhamoui FA, Welk A, Altarabulsi MB, Alkilzy M, H Splieth C. A randomized clinical trial on the use of medical Portland cement, MTA and calcium hydroxide in indirect pulp treatment. Clin Oral Investig. 2014;18(5):1383-9. doi: 10.1007/s00784-013-1107-z. Epub 2013 Sep 17.

  PMID: 24043482 BACKGROUND

MeSH Terms

Interventions

TheraCal; Biner LC

Study Officials

• Omaima M Safwat, PHD

  Professor of Conservative Dentistry, Cairo University

  STUDY DIRECTOR

• Mohsen A Elhassan, PHD

  Professor of Conservative Dentistry, Cairo University

  STUDY CHAIR

Central Study Contacts

Hanaa M Morsy, master

CONTACT

01125930006; hanaastamos@gmail.com

Hanaa M Morsy, Master

CONTACT

01125930006; hanaa_stamos@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: It will be a single-blinded study so that the participant will be blinded, the researcher and the data analysis will be unblinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master student at conservative department

Study Record Dates

• First Submitted: July 10, 2017
• First Posted: July 12, 2017
• Study Start: August 10, 2018
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2019
• Last Updated: August 1, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)