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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02805101
Enrollment
30
Registered
2016-06-17
Start date
2015-01-31
Completion date
2017-10-30
Last updated
2018-01-03

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

Conditions

Root Perforation at the Bifurcation Area

Brief summary

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.

Interventions

DRUGBiodentine

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

DRUGMTA

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

Sponsors

Damascus University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
15 Years to 30 Years
Healthy volunteers
No

Inclusion criteria

1. vital molars (upper or lower ) 2. 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 3. Perforation should not exceed the size of 3 mm 4. Perforation and must also take into account the time of perforation.

Exclusion criteria

1. If the molar not vital. 2. If the perforation not in bifurcation root or extended inside the canals. 3. Size of perforation larger than 3 mm. 4. A long time ago on the occurrence of perforation with resorption in tooth structure.

Design outcomes

Primary

MeasureTime frameDescription
Success at 3 months following root sealingThe success of treatment is assessed at three months following the application of the materialCase is considered successful if clinical and radiographic examinations of the tooth are sound 100%.
Success at 6 months following root sealingThe success of treatment is assessed at 6 months following the application of the materialCase is considered successful if clinical and radiographic examinations of the tooth are sound 100%.
Success at 9 months following root sealingThe success of treatment is assessed at 9 months following the application of the materialCase is considered successful if clinical and radiographic examinations of the tooth are sound 100%.
Success at 12 months following root sealingThe success of treatment is assessed at 12 months following the application of the materialCase is considered successful if clinical and radiographic examinations of the tooth are sound 100%.
Success at 18 months following root sealingThe success of treatment is assessed at 18 months following the application of the materialCase is considered successful if clinical and radiographic examinations of the tooth are sound 100%.
Success at 24 months following root sealingThe success of treatment is assessed at 24 months following the application of the materialCase is considered successful if clinical and radiographic examinations of the tooth are sound 100%.

Countries

Syria

Outcome results

None listed

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