Prospective Clinical Trial of Three Apical Sealing Materials | NCT04198298

Studies
Prospective Clinical Trial of Three Apical Sealing Materials

NCT04198298

Sponsor

University of the Pacific

Status

Completed

Last Update Posted

Dec 13, 2019Actual

Enrollment

59Actual

Phase

Phase 4

Conditions

Periapical Abscess

Interventions

EndoSequence
ProRoot MTA
Biodentine

Countries

Not provided

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

Nov 2019

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

Nov 2, 2014Actual

Primary Completion Date

May 31, 2017Actual

Completion Date

May 31, 2017Actual

First Submitted Date

Dec 12, 2019

First Submission Date that Met QC Criteria

Dec 12, 2019

First Posted Date

Dec 13, 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

Dec 12, 2019

Last Update Posted Date

Dec 13, 2019Actual

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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This prospective comparative randomized clinical trial compares healing and bony regeneration in patients who received 1 of 3 different retrograde filling materials following microsurgical apicoectomies for the treatment of periapical lesions of endodontic origin.

Detailed Description

A prospective comparative randomized clinical trial was designed to evaluate the healing and bony regeneration in patients who received 1 of 3 different retrograde filling materials (EndoSequence®, ProRoot® MTA, or Biodentine®) following microsurgical apicoectomies for the treatment of periapical lesions of endodontic origin.

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

59Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1 EndoSequence	Active Comparator	The EndoSequence® retrograde sealing material was used to provide a biologic seal at the apex.	Drug: EndoSequence
Group 2 ProRoot MTA	Active Comparator	The ProRoot® MTA retrograde sealing material was used to provide a biologic seal at the apex.	Drug: ProRoot MTA
Group 3 Biodentine	Active Comparator	The Biodentine® retrograde sealing material was used to provide a biologic seal at the apex.	Drug: Biodentine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
EndoSequence	Drug	The EndoSequence® retrograde sealing material was used to provide a biologic seal at the apex.	Group 1 EndoSequence

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Rate of remineralization	The pace at which new bone is redeposited	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult patients, American Society of Anesthesiologists (ASA) classification I and II
Any tooth with a single chronic periapical lesion requiring apical microsurgery
Informed consent signed prior to surgery

Exclusion Criteria:

Background of drug/alcohol abuse
Adjacent periapical lesion
Periodontal disease

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010482	Periapical Abscess

Ancestor Terms

ID	Term
D000038	Abscess
D013492	Suppuration
D007239	Infections
D010485	Periapical Periodontitis

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C550603	EndoSequence root repair material
C000624565	ProRoot MTA
C506393	tricalcium silicate

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided