- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04198298
Prospective Clinical Trial of Three Apical Sealing Materials
December 12, 2019 updated by: University of the Pacific
Prospective Comparative Randomized Clinical Trial of Three Endodontic Retrograde Filling Materials
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
59
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Group 1 EndoSequence
The EndoSequence® retrograde sealing material was used to provide a biologic seal at the apex.
|
The EndoSequence® retrograde sealing material was used to provide a biologic seal at the apex.
Other Names:
|
Active Comparator: Group 2 ProRoot MTA
The ProRoot® MTA 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.
Other Names:
|
Active Comparator: Group 3 Biodentine
The Biodentine® 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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of remineralization
Time Frame: 6 months
|
The pace at which new bone is redeposited
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 2, 2014
Primary Completion (Actual)
May 31, 2017
Study Completion (Actual)
May 31, 2017
Study Registration Dates
First Submitted
December 12, 2019
First Submitted That Met QC Criteria
December 12, 2019
First Posted (Actual)
December 13, 2019
Study Record Updates
Last Update Posted (Actual)
December 13, 2019
Last Update Submitted That Met QC Criteria
December 12, 2019
Last Verified
November 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20-60
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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