Radiographic Assessment of Calcific Bridge Formation by Light Activated Calcium Silicate Versus Calcium Hydroxide for Deep Caries

July 19, 2018 updated by: basma gamal hassan, Cairo University

Radiographic Assessment of Calcific Bridge Formation by Light Activated Calcium Silicate Versus Light Activated Calcium Hydroxide in Management of Simple Deeply Seated Carious Lesions With Partial Caries Removal

sixty participants will be divided in to two groups (n=30) of patient treated by partial caries removal according to the capping material (A),where (A1)represents calcium silicate group,(A2)represent calcium hydroxide group.Apply light activated calcium silicate for group (A1) in deep occlusal caries and taking the base line image after restoring the cavity with composite restoration and apply light activated calcium hydroxide for(A2)group in deep occlusal caries and taking the base line image after restoring with composite restoration.Take follow up image after one year to measure the calcific bridge formation for both groups.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Management of deep carious lesion may constitute a real challenge for the operator.The basic idea for treating deep caries is to enhance calcific reparative capacity.Calcium hydroxide has been the gold standard as a capping material but there are some drawbacks like solubility,gaps formation and mechanical instability so a need for a capping material such as calcium silicate has shown several advantages.

Sixty participants will be divided in to two groups (n=30) of patient treated by partial caries removal.The first group(A1) will be treated by light activated calcium silicate and the second group(A2) will be treated by light activated calcium hydroxide after partial caries removal of deep occlusal caries then restore by composite restoration.Paralleling technique using film holders and custom made bite blocks will be used to standardize the serial radiographs and to prevent the distortion of the radiographic image.An increase in dentin thickness will be measured through sequential imaging by soft ware named Digora (Digora Optime,Soredex,Helsinki,Finland) will be used for measurements by digitalizing the scanned image.All images will be studied carefully for an increase in dentin thickness keeping the reference point constant from the furcation area.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Normal adults will be recruited in this study ,all the volunteers participated in this experiment will be healthy looking free medical history.
  • Patients have simple deep carious lesions in his /her mouth with no pain or history of sensitivity to cold which disappear immediately after removal of the stimulus.

Exclusion Criteria:

  • Medically compromised patients and teeth with history of spontaneous pain or tenderness to percussion were excluded from the study.
  • Pregnant females will be excluded from the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: light activated calcium silicate
Apply light activated calcium silicate in deep occlusal caries lesions and taking the base line image for the first group after restoring the cavity with composite restoration and taking the follow up x-ray image after one year to measure the calcific bridge formation.
Other: light activated calcium silicate

for the first group light activated calcium silicate can be easily placed by a 20 second light cure and ability to be syringed directly on to the cavity preparation and restore the cavity by composite restoration.

for the second group using light activated calcium hydroxide is placed by placing a disposable tip securely on to the syringe then light cure for 20 seconds depending on the light cure unit and restore the cavity with composite restoration.

Other Names:
  • light activated calcium hydroxide
Active Comparator: light activated calcium hydroxide
Apply the light activated calcium hydroxide in deep occlusal carious lesions and taking the base line image for the second group after restoring with composite restoration and taking the follow up x-ray image after one year to measure the calcific bridge formation.
Other: light activated calcium silicate

for the first group light activated calcium silicate can be easily placed by a 20 second light cure and ability to be syringed directly on to the cavity preparation and restore the cavity by composite restoration.

for the second group using light activated calcium hydroxide is placed by placing a disposable tip securely on to the syringe then light cure for 20 seconds depending on the light cure unit and restore the cavity with composite restoration.

Other Names:
  • light activated calcium hydroxide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
calcific bridge formation will be measured by digora software
Time Frame: 1 year
in millimeters
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 1, 2018

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

July 25, 2017

First Submitted That Met QC Criteria

July 27, 2017

First Posted (Actual)

July 31, 2017

Study Record Updates

Last Update Posted (Actual)

July 20, 2018

Last Update Submitted That Met QC Criteria

July 19, 2018

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEBC-CU-2017-07-21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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