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Prospective Clinical Trial of Three Apical Sealing Materials

Prospective Comparative Randomized Clinical Trial of Three Endodontic Retrograde Filling Materials

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04198298
Enrollment
59
Registered
2019-12-13
Start date
2014-11-02
Completion date
2017-05-31
Last updated
2019-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Periapical Abscess

Keywords

Cone-Beam Computed Tomography, Microsurgery, Bone Regeneration, Biocompatible Materials

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.

Interventions

DRUGEndoSequence

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.

DRUGBiodentine

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

Sponsors

University of the Pacific
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Rate of remineralization6 monthsThe pace at which new bone is redeposited

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026