NCT03032978

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 14, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 26, 2017

Completed
1.2 years until next milestone

Study Start

First participant enrolled

April 20, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2019

Completed
Last Updated

January 27, 2020

Status Verified

January 1, 2020

Enrollment Period

11 months

First QC Date

January 14, 2017

Last Update Submit

January 22, 2020

Conditions

Deep Caries

Outcome Measures

Primary Outcomes (1)

  • Pain: VAS

    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

Study Arms (2)

Calcium silicate

EXPERIMENTAL

intervention

Other: Calcium silicate

Calcium Hydroxide

ACTIVE COMPARATOR

Comparator

Other: Calcium hydroxide

Interventions

Calcium hydroxideOTHER

Pulp capping material

Also known as: Dycal
Calcium Hydroxide
Calcium silicateOTHER

Pulp capping material

Also known as: Theracal
Calcium silicate

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ehsan Hossam

Cairo, Giza Governorate, 12345, Egypt

Location

MeSH Terms

Interventions

Calcium HydroxideDycalcalcium silicateTheraCal

Intervention Hierarchy (Ancestors)

HydroxidesAlkaliesInorganic ChemicalsCalcium CompoundsAnionsIonsElectrolytes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer conservative dentistry - Ahram canadian university

Study Record Dates

First Submitted

January 14, 2017

First Posted

January 26, 2017

Study Start

April 20, 2018

Primary Completion

March 1, 2019

Study Completion

May 15, 2019

Last Updated

January 27, 2020

Record last verified: 2020-01

Locations

EG(1)