Prospective Clinical Trial of Three Apical Sealing Materials

Study Overview
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Brief Summary
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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
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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.

Official Title
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Prospective Comparative Randomized Clinical Trial of Three Endodontic Retrograde Filling Materials

Conditions
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Periapical Abscess

Intervention / Treatment
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* Drug: EndoSequence
* Drug: ProRoot MTA
* Drug: Biodentine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1 EndoSequence<br>The EndoSequence® retrograde sealing material was used to provide a biologic seal at the apex. | Drug: EndoSequence<br>* The EndoSequence® retrograde sealing material was used to provide a biologic seal at the apex.<br>* Other names: EndoSequence®;|
| Active Comparator: Group 2 ProRoot MTA<br>The ProRoot® MTA retrograde sealing material was used to provide a biologic seal at the apex. | Drug: ProRoot MTA<br>* The ProRoot® MTA retrograde sealing material was used to provide a biologic seal at the apex.<br>* Other names: ProRoot® MTA;|
| Active Comparator: Group 3 Biodentine<br>The Biodentine® retrograde sealing material was used to provide a biologic seal at the apex. | Drug: Biodentine<br>* The Biodentine® retrograde sealing material was used to provide a biologic seal at the apex.<br>* Other names: Biodentine®;|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cone-Beam Computed Tomography, Microsurgery, Bone Regeneration, Biocompatible Materials