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Clinical Trials/NCT03395496
NCT03395496
Completed
Early Phase 1

Comparison of Biodentine and MTA Pulpotomies in the Primary Molar Teeth 3 Year Follow up

Istanbul University1 site in 1 country200 target enrollmentMay 1, 2013

Overview

Phase
Early Phase 1
Intervention
Biodentine
Conditions
Pulpotomy
Sponsor
Istanbul University
Enrollment
200
Locations
1
Primary Endpoint
Total success rate
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 1, 2013
End Date
May 30, 2016
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mine Koruyucu

Principal Investigator

Istanbul University

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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

Arms & Interventions

ProRoot MTA

Dental Materials

Intervention: Biodentine

Biodentine

Dental materials

Intervention: Biodentine

Biodentine

Dental materials

Intervention: ProRoot (Aggregate)

ProRoot MTA

Dental Materials

Intervention: ProRoot (Aggregate)

Outcomes

Primary Outcomes

Total success rate

Time Frame: 12 months after pulpotomy treatment

Secondary Outcomes

  • Total success rate(24 months after pulpotomy treatment)

Study Sites (1)

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