Prospective Clinical Trial of Three Apical Sealing Materials

Periapical Abscess Clinical Trial

Official title:

Prospective Comparative Randomized Clinical Trial of Three Endodontic Retrograde Filling Materials

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04198298
• Other study ID #: 20-60
• Status: Completed
• Phase: Phase 4
• Start date: November 2, 2014
• Est. completion date: May 31, 2017

Study information

• Verified date: November 2019
• Source: University of the Pacific
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: May 31, 2017
• Est. primary completion date: May 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Periapical Abscess

Intervention

Drug:
• EndoSequence
The EndoSequence® retrograde sealing material was used to provide a biologic seal at the apex.
• ProRoot MTA
The ProRoot® MTA retrograde sealing material was used to provide a biologic seal at the apex.
• Biodentine
The Biodentine® retrograde sealing material was used to provide a biologic seal at the apex.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of the Pacific

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of remineralization	The pace at which new bone is redeposited	6 months