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NCT Number: NCT02805101

Comparative Study Between Biodentine and Mineral Trioxide Aggregate in Sealing Root Perforations

This is a study aimed to compare two materials: (1) Biodentine and (2) MTA. These two materials are going to be tested in sealing accidental root perforations at the bifurcation areas. The study is going to be conducted as a randomized controlled trial.

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Key information

Conditions

Root Perforation at the Bifurcation Area

Age range

15 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Operative Dentistry, University of Damascus Dental School

Damascus, DM20AM18, Syria

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • vital molars (upper or lower )
  • suffered from perforation in the bifurcation area of the roots through a process of open access cavity, taking into account the location and size of perforation
  • Perforation should not exceed the size of 3 mm
  • Perforation and must also take into account the time of perforation.

Exclusion criteria

  • If the molar not vital.
  • If the perforation not in bifurcation root or extended inside the canals.
  • Size of perforation larger than 3 mm.
  • A long time ago on the occurrence of perforation with resorption in tooth structure.

Treatment and study plan

Biodentine

Drug

Biodentine is going to be used as the sealing agent for the perforation.

MTA

Drug

MTA is going to be used as the sealing agent for the perforation.

Primary outcomes

  1. Success at 3 months following root sealing

    Time frame: The success of treatment is assessed at three months following the application of the material

    Case is considered successful if clinical and radiographic examinations of the tooth are sound 100%.

  2. Success at 6 months following root sealing

    Time frame: The success of treatment is assessed at 6 months following the application of the material

    Case is considered successful if clinical and radiographic examinations of the tooth are sound 100%.

  3. Success at 9 months following root sealing

    Time frame: The success of treatment is assessed at 9 months following the application of the material

    Case is considered successful if clinical and radiographic examinations of the tooth are sound 100%.

  4. Success at 12 months following root sealing

    Time frame: The success of treatment is assessed at 12 months following the application of the material

    Case is considered successful if clinical and radiographic examinations of the tooth are sound 100%.

  5. Success at 18 months following root sealing

    Time frame: The success of treatment is assessed at 18 months following the application of the material

    Case is considered successful if clinical and radiographic examinations of the tooth are sound 100%.

  6. Success at 24 months following root sealing

    Time frame: The success of treatment is assessed at 24 months following the application of the material

    Case is considered successful if clinical and radiographic examinations of the tooth are sound 100%.

Sponsors and collaborators

Lead sponsor

Damascus University

Other

Registry information

Official study title

A Comparative Study of the Performance of Biodentine and Mineral Trioxide Aggregate (MTA) in Sealing Root Perforations.

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jun 17, 2016
Registry last updated
Jan 3, 2018

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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