Comparison of Sealing Ability of MTA and Biodentine for Repairing of Furcal Perforation in Primary Molars
1 other identifier
interventional
42
0 countries
N/A
Brief Summary
- Preservation of the primary teeth is a mandatory issue for maintaining the integrity of the normal dentition and functioning till the eruption of the successors.
- furcal perforations may occur due to iatrogenic and non-iatrogenic causes.
- Despite the high successful outcomes in perforation repair with MTA, there are some issues which prevent the clinicians from using it for many cases such as its very long setting time and its difficult manipulation.
- Biodentin could be used as an alternative to MTA in reparative treatment procedures due to its ability to provide a hermetic seal and durable restoration and thus an optimal sealing is expected.
- The importance of the trial lies in testing the sealing ability of Biodentine using scanning electron microscope. Biodentine has short setting time and is easier in manipulation than MTA which are major needs when dealing with pediatric patients to be able to give best results in short time.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2021
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 9, 2021
CompletedFirst Posted
Study publicly available on registry
August 16, 2021
CompletedStudy Start
First participant enrolled
September 10, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 10, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 10, 2022
CompletedAugust 25, 2021
August 1, 2021
Same day
August 9, 2021
August 19, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
sealing ability
* measured by scanning electron microscope * Unit of measurement : µm
24 hours
Study Arms (2)
control group
EXPERIMENTALthe group of primary molar teeth that will be treated in furcal perforation with Mineral Trioxide Aggregate
experimental group
EXPERIMENTALthe group of primary molar teeth that will be treated in furcal perforation with Biodentine
Interventions
Mineral Trioxide Aggregate stimulates cementoblasts to produce matrix for cementum formation and is biocompatible with the periradicular tissues thus shows a superior sealing ability when used in perforation repair
Biodentine has a good sealing ability, high compressive strengths, short setting time, biocompatibility, bioactivity and biomineralization properties that make it available to be used in endodontic repair procedures
Eligibility Criteria
You may qualify if:
- Freshly extracted discarded primary molars
- Primary molars with intact furcation ( no caries, no perforation, no resorption )
- Physiologic root resorption not more than two-third of root length
You may not qualify if:
- Exfoliated primary molars
- Primary molars with internal resorption
- Primary molars with extensive tooth decay of the crown
- Primary molars with discoloration
- Cracked tooth
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- student
Study Record Dates
First Submitted
August 9, 2021
First Posted
August 16, 2021
Study Start
September 10, 2021
Primary Completion
September 10, 2021
Study Completion
September 10, 2022
Last Updated
August 25, 2021
Record last verified: 2021-08
Data Sharing
- IPD Sharing
- Will not share