Prospective Clinical Trial of Three Apical Sealing Materials

Phase 4

Completed

• Conditions: Periapical Abscess
• Interventions: Drug: ProRoot MTA; Drug: Biodentine; Drug: EndoSequence

• Registration Number: NCT04198298
• Lead Sponsor: University of the Pacific

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.

Study Timeline

• Study Start: 2014-11-02
• Primary Completion: 2017-05-31
• Study Completion: 2017-05-31
• Status Verified: 2019-11
• Study First Submitted: 2019-12-12
• Study First Submitted QC: 2019-12-12
• Last Update Submitted: 2019-12-12
• Study First Posted: 2019-12-13
• Last Update Posted: 2019-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2 ProRoot MTA	ProRoot MTA	The ProRoot® MTA retrograde sealing material was used to provide a biologic seal at the apex.
Group 3 Biodentine	Biodentine	The Biodentine® retrograde sealing material was used to provide a biologic seal at the apex.
Group 1 EndoSequence	EndoSequence	The EndoSequence® retrograde sealing material was used to provide a biologic seal at the apex.

Primary Outcome Measures

Name	Time	Method
Rate of remineralization	6 months	The pace at which new bone is redeposited