- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03032978
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
Intervention / Treatment
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:
|
|
ACTIVE_COMPARATOR: Calcium Hydroxide
Comparator
|
Pulp capping material
Other Names:
|
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.
Sponsor
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- CEBD-CU-2017-01-06
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.