Randomized Clinical Trial for Primary Molar Pulpotomy, Bi... | NCT02201498

Studies
Randomized Clinical Trial for Primary Molar Pulpotomy, Biodentine Vs Formocresol-ZOE

NCT02201498

Sponsor

Université de Montréal

Status

Completed

Last Update Posted

Jan 12, 2018Actual

Enrollment

180Estimated

Phase

Not Applicable

Conditions

Deep Dental Caries

Interventions

Pulpotomies with Formocresol/OZE and Biodentine

Countries

Canada

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 2018

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

Sep 2014

Primary Completion Date

Jun 2016Actual

Completion Date

Jun 2016Actual

First Submitted Date

Jul 24, 2014

First Submission Date that Met QC Criteria

Jul 24, 2014

First Posted Date

Jul 28, 2014Estimated

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 10, 2018

Last Update Posted Date

Jan 12, 2018Actual

Name	Class
Septodont	INDUSTRY
St. Justine's Hospital	OTHER

Description Module

Brief Summary

This is a RCT that will compare the clinical and radiographic success of pulpotomies on primary molars between the traditional technique (Formocresol/ZOE) and the new technique with Biodentine. 180 pulpotomies (90 in each group) will be followed for a period of 12 months.

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

180Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Formocresol/OZE	Active Comparator	Conventional pulpotomy technique, with formocresol and zinc oxide eugenol	Procedure: Pulpotomies with Formocresol/OZE and Biodentine
Biodentine	Active Comparator	New technique, with biodentine	Procedure: Pulpotomies with Formocresol/OZE and Biodentine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pulpotomies with Formocresol/OZE and Biodentine	Procedure		Biodentine Formocresol/OZE

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
clinical success		12 months post treatment
radiographic success		12 months post treatment

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ASA I and II
less than 1/3 of physiologic root resorption
asymptomatic tooth (with no history of symptoms)
no clinical or radiological sign of pathology
vital tooth, with carious pulpal exposure
hemostasis must be obtained simply with pressure in less than 5 min
teeth restored with stainless steel crowns

Exclusion Criteria:

more than 10 y.o.
symptomatic tooth (presently or history of symptoms)
previous pulpal treatment on the tooth
necrotic pulp
hyperemic pulp
inadequate operative technique, defective restauration
non diagnostic x-ray (pre or post treatment)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

10 Years

Standard Ages

Child

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
CHU Sainte-Justine		Montreal	Quebec	h3t1c5	Canada

Intervention Browse Module

MeSH Terms

ID	Term
D011672	Pulpotomy
C506393	tricalcium silicate

Ancestor Terms

ID	Term
D004708	Endodontics
D003813	Dentistry

Browse Leaves

Not provided

Browse Branches

Not provided