Calcium Silicate Versus Calcium Hydroxide in Two-step Indirect Pulp Treatment

January 22, 2020 updated by: ehsan hossam, Cairo University

Clinical and Microbiological Evaluation of Calcium Silicate Versus Calcium Hydroxide in Two-step Indirect Pulp Treatment: Randomized Clinical Trial

Clinical and microbiological evaluation of Calcium silicate versus Calcium hydroxide in two-step indirect pulp treatment: Randomized clinical trial

Study Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

50

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.

Study Locations

    • Giza Governorate
      • Cairo, Giza Governorate, Egypt, 12345
        • Ehsan Hossam

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

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18-50 years.
  • Males or females.
  • Co-operative patients approving to participate in the trial.

Exclusion Criteria:

  • Patients younger than 19 years old or older than 50 years old.
  • Disabilities.
  • Systemic diseases or severe medically compromised.
  • Lack of compliance.

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
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Calcium silicate
intervention
Pulp capping material
Other Names:
  • Theracal
ACTIVE_COMPARATOR: Calcium Hydroxide
Comparator
Pulp capping material
Other Names:
  • Dycal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain: VAS
Time Frame: 6 month
post operative pain after 6 month from material application will be measured by visual analogue scale (VAS)with score from 0 to 10 in which 0 means no pain and 10 means the worst pain
6 month

Collaborators and Investigators

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

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 (ACTUAL)

April 20, 2018

Primary Completion (ACTUAL)

March 1, 2019

Study Completion (ACTUAL)

May 15, 2019

Study Registration Dates

First Submitted

January 14, 2017

First Submitted That Met QC Criteria

January 24, 2017

First Posted (ESTIMATE)

January 26, 2017

Study Record Updates

Last Update Posted (ACTUAL)

January 27, 2020

Last Update Submitted That Met QC Criteria

January 22, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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