NCT04198298

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
59

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Nov 2014

Typical duration for phase_4

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

Study Start

First participant enrolled

November 2, 2014

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2017

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

December 12, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 13, 2019

Completed
Last Updated

December 13, 2019

Status Verified

November 1, 2019

Enrollment Period

2.6 years

First QC Date

December 12, 2019

Last Update Submit

December 12, 2019

Conditions

Periapical Abscess

Keywords

Cone-Beam Computed TomographyMicrosurgeryBone RegenerationBiocompatible Materials

Outcome Measures

Primary Outcomes (1)

  • Rate of remineralization

    The pace at which new bone is redeposited

    6 months

Study Arms (3)

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

EndoSequenceDRUG

The EndoSequence® retrograde sealing material was used to provide a biologic seal at the apex.

Also known as: EndoSequence®
Group 1 EndoSequence
ProRoot MTADRUG

The ProRoot® MTA retrograde sealing material was used to provide a biologic seal at the apex.

Also known as: ProRoot® MTA
Group 2 ProRoot MTA
BiodentineDRUG

The Biodentine® retrograde sealing material was used to provide a biologic seal at the apex.

Also known as: Biodentine®
Group 3 Biodentine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Background of drug/alcohol abuse
  • Adjacent periapical lesion
  • Periodontal disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Periapical Abscess

Interventions

EndoSequence root repair materialProRoot MTAtricalcium silicate

Condition Hierarchy (Ancestors)

AbscessSuppurationInfectionsPeriapical PeriodontitisPeriapical DiseasesJaw DiseasesStomatognathic DiseasesPeriodontal DiseasesMouth DiseasesPeriodontitis

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2019

First Posted

December 13, 2019

Study Start

November 2, 2014

Primary Completion

May 31, 2017

Study Completion

May 31, 2017

Last Updated

December 13, 2019

Record last verified: 2019-11