Calcium Silicate Versus Calcium Hydroxide in Two-step Ind... | NCT03032978

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

NCT03032978

Sponsor

Cairo University

Status

Completed

Last Update Posted

Jan 27, 2020Actual

Enrollment

50Actual

Phase

Not Applicable

Conditions

Deep Caries

Interventions

Calcium hydroxide
Calcium silicate

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 20, 2018Actual

Primary Completion Date

Mar 1, 2019Actual

Completion Date

May 15, 2019Actual

First Submitted Date

Jan 14, 2017

First Submission Date that Met QC Criteria

Jan 24, 2017

First Posted Date

Jan 26, 2017Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 22, 2020

Last Update Posted Date

Jan 27, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

ehsan hossam, Assistant lecturer conservative dentistry - Ahram canadian university, Cairo UniversityPrincipal Investigator

Lead Sponsor

Cairo UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Calcium silicate	Experimental	intervention	Other: Calcium silicate
Calcium Hydroxide	Active Comparator	Comparator	Other: Calcium hydroxide

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Calcium hydroxide	Other	Pulp capping material	Calcium Hydroxide	Dycal

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ehsan Hossam		Cairo	Giza Governorate	12345	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002126	Calcium Hydroxide
C025702	Dycal
C031293	calcium silicate
C000632580	TheraCal

Ancestor Terms

ID	Term
D006878	Hydroxides
D000468	Alkalies
D007287	Inorganic Chemicals
D017610	Calcium Compounds

Browse Leaves

Not provided

Browse Branches

Not provided