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

Sponsor
Cairo University (Other)
Overall Status
Completed
CT.gov ID
NCT03032978
Collaborator
(none)
50
Enrollment
1
Location
2
Arms
12.8
Actual Duration (Months)
3.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: Calcium hydroxide
  • Other: Calcium silicate
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Care Provider, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Clinical and Microbiological Evaluation of Calcium Silicate Versus Calcium Hydroxide in Two-step Indirect Pulp Treatment: Randomized Clinical Trial
Actual Study Start Date :
Apr 20, 2018
Actual Primary Completion Date :
Mar 1, 2019
Actual Study Completion Date :
May 15, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Calcium silicate

intervention

Other: Calcium silicate
Pulp capping material
Other Names:
  • Theracal

    		•
    Active Comparator: Calcium Hydroxide

    Comparator

    Other: Calcium hydroxide
    Pulp capping material
    Other Names:
  • Dycal

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Pain: VAS [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ehsan Hossam Cairo Giza Governorate Egypt 12345

    Sponsors and Collaborators

    • Cairo University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    ehsan hossam, Assistant lecturer conservative dentistry - Ahram canadian university, Cairo University
    ClinicalTrials.gov Identifier:
    NCT03032978
    Other Study ID Numbers:
    • CEBD-CU-2017-01-06
    First Posted:
    Jan 26, 2017
    Last Update Posted:
    Jan 27, 2020
    Last Verified:
    Jan 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    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
    Additional relevant MeSH terms:
    Calcium, Dietary
    Calcium

    Study Results

    No Results Posted as of Jan 27, 2020