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Completed

NCT Number: NCT04198298

Prospective Clinical Trial of Three Apical Sealing 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.

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Key information

Conditions

Periapical Abscess Abscess Infections Jaw Diseases Mouth Diseases Periapical Diseases Periapical Periodontitis Periodontal Diseases Periodontitis Stomatognathic Diseases Suppuration

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EndoSequence

Drug

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

Other names: EndoSequence®

ProRoot MTA

Drug

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

Other names: ProRoot® MTA

Biodentine

Drug

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

Other names: Biodentine®

Primary outcomes

  1. Rate of remineralization

    Time frame: 6 months

    The pace at which new bone is redeposited

Sponsors and collaborators

Lead sponsor

University of the Pacific

Other

Registry information

Official study title

Prospective Comparative Randomized Clinical Trial of Three Endodontic Retrograde Filling Materials

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Dec 13, 2019
Registry last updated
Dec 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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