Evaluation of Furcal Perforation Repair in Primary Molars... | NCT04137861

Studies
Evaluation of Furcal Perforation Repair in Primary Molars With MTA Versus Bioceramics (A Randomized Clinical Trial)

NCT04137861

Sponsor

Ahmad Elheeny

Status

Completed

Last Update Posted

Feb 25, 2021Actual

Enrollment

76Actual

Phase

Not Applicable

Conditions

Iatrogenic Perforation of Primary Molars

Interventions

Bioceramics

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

Feb 2021

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

Oct 25, 2019Actual

Primary Completion Date

Aug 25, 2020Actual

Completion Date

Oct 25, 2020Actual

First Submitted Date

Oct 20, 2019

First Submission Date that Met QC Criteria

Oct 23, 2019

First Posted Date

Oct 24, 2019Actual

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

Feb 23, 2021

Last Update Posted Date

Feb 25, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Furcal perforation is one of the most challenging procedural accidents during pulpotomy of primary molars and should be sealed as soon as possible to prevent bacterial invasion at perforation site and subsequent tooth extraction. The aim of the study is to compare bioceramics versus MTA as root repair material for treatment of furcal perforation in primary molars

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

76Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Mineral Trioxide Aggregate (MTA)	Active Comparator	Root repair material	Other: Bioceramics
bioceramics	Experimental	Root repair material	Other: Bioceramics

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bioceramics	Other	root repair material	Mineral Trioxide Aggregate (MTA) bioceramics

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
clinical success	Visual oral examination	9 months
radiographic success	Radiolucency assessment (+/-)	9 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Apparently healthy children aged from 4 to 7 years
No history of spontaneous pain or swelling
No signs or symptoms of irreversible pulpits or loss of vitality
Absence of radicular or priapical lesions.
Accidental furcal perforation should be immediate or mediate (within two weeks) perforation in primary molars.

Exclusion Criteria:

Children with systemic disease
Presence of priapical lesions

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

4 Years

Maximum Age

7 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Minia University		Minya		61111	Egypt

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33483869	Derived	Abdelmotelb MA, Gomaa YF, Khattab NMA, Elheeny AAH. Premixed bioceramics versus mineral trioxide aggregate in furcal perforation repair of primary molars: in vitro and in vivo study. Clin Oral Investig. 2021 Aug;25(8):4915-4925. doi: 10.1007/s00784-021-03800-3. Epub 2021 Jan 22.