Prospective Clinical Trial of Three Apical Sealing Materials
Primary Purpose
Periapical Abscess
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
EndoSequence
ProRoot MTA
Biodentine
Sponsored by
About this trial
This is an interventional treatment trial for Periapical Abscess focused on measuring Cone-Beam Computed Tomography, Microsurgery, Bone Regeneration, Biocompatible Materials
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Group 1 EndoSequence
Group 2 ProRoot MTA
Group 3 Biodentine
Arm Description
The EndoSequence® retrograde sealing material was used to provide a biologic seal at the apex.
The ProRoot® MTA retrograde sealing material was used to provide a biologic seal at the apex.
The Biodentine® retrograde sealing material was used to provide a biologic seal at the apex.
Outcomes
Primary Outcome Measures
Rate of remineralization
The pace at which new bone is redeposited
Secondary Outcome Measures
Full Information
NCT ID
NCT04198298
First Posted
December 12, 2019
Last Updated
December 12, 2019
Sponsor
University of the Pacific
1. Study Identification
Unique Protocol Identification Number
NCT04198298
Brief Title
Prospective Clinical Trial of Three Apical Sealing Materials
Official Title
Prospective Comparative Randomized Clinical Trial of Three Endodontic Retrograde Filling Materials
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
November 2, 2014 (Actual)
Primary Completion Date
May 31, 2017 (Actual)
Study Completion Date
May 31, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of the Pacific
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periapical Abscess
Keywords
Cone-Beam Computed Tomography, Microsurgery, Bone Regeneration, Biocompatible Materials
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
59 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1 EndoSequence
Arm Type
Active Comparator
Arm Description
The EndoSequence® retrograde sealing material was used to provide a biologic seal at the apex.
Arm Title
Group 2 ProRoot MTA
Arm Type
Active Comparator
Arm Description
The ProRoot® MTA retrograde sealing material was used to provide a biologic seal at the apex.
Arm Title
Group 3 Biodentine
Arm Type
Active Comparator
Arm Description
The Biodentine® retrograde sealing material was used to provide a biologic seal at the apex.
Intervention Type
Drug
Intervention Name(s)
EndoSequence
Other Intervention Name(s)
EndoSequence®
Intervention Description
The EndoSequence® retrograde sealing material was used to provide a biologic seal at the apex.
Intervention Type
Drug
Intervention Name(s)
ProRoot MTA
Other Intervention Name(s)
ProRoot® MTA
Intervention Description
The ProRoot® MTA retrograde sealing material was used to provide a biologic seal at the apex.
Intervention Type
Drug
Intervention Name(s)
Biodentine
Other Intervention Name(s)
Biodentine®
Intervention Description
The Biodentine® retrograde sealing material was used to provide a biologic seal at the apex.
Primary Outcome Measure Information:
Title
Rate of remineralization
Description
The pace at which new bone is redeposited
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
12. IPD Sharing Statement
Learn more about this trial
Prospective Clinical Trial of Three Apical Sealing Materials
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