Comparison of Biodentine and MTA Pulpotomies in the Primary Molar Teeth 3 Year Follow up
1 other identifier
interventional
200
1 country
1
Brief Summary
The aim of this study is to compare two pulpotomy medicaments in primary molars clinically.A total of 200 primary molars with deep caries were treated with two different pulpotomy medicaments (Mineral Trioxide Aggregate and BiodentineTM) in this study. The inclusion criteria for tooth selection were no clinical and radiographic evidence of pulp pathology. During 36 months of follow-up at 3-month intervals, clinical and radiographic success and failures were recorded.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for early_phase_1
Started May 2013
Typical duration for early_phase_1
1 active site
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
Study Start
First participant enrolled
May 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2016
CompletedFirst Submitted
Initial submission to the registry
December 26, 2017
CompletedFirst Posted
Study publicly available on registry
January 10, 2018
CompletedJanuary 10, 2018
January 1, 2018
3 years
December 26, 2017
January 3, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Total success rate
12 months after pulpotomy treatment
Secondary Outcomes (1)
Total success rate
24 months after pulpotomy treatment
Other Outcomes (1)
Total success rate
36 months after pulpotomy treatment
Study Arms (2)
Biodentine
EXPERIMENTALDental materials
ProRoot MTA
EXPERIMENTALDental Materials
Interventions
Eligibility Criteria
You may qualify if:
- no clinical and radiographic evidence of pulp pathology,
- no clinical and radiographic symptoms,
- no history of spontaneous pain and tenderness,
- no percussion, swelling or sinus tracts and pathologic mobility.
You may not qualify if:
- any clinical or radiographic evidence of pulp degeneration (spontaneous or nocturnal tooth pain, tenderness to percussion, pathological mobility, internal or external root resorption, swelling or fistula, widened periodontal ligament (PDL)
- furcal or periapical radiolucency teeth requiring more than 5 minutes to achieve hemostasis during clinical procedure.
- without permanent successor
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Istanbul University
Istanbul, 34093, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
December 26, 2017
First Posted
January 10, 2018
Study Start
May 1, 2013
Primary Completion
May 1, 2016
Study Completion
May 30, 2016
Last Updated
January 10, 2018
Record last verified: 2018-01