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NCT03395496 Clinical Trial

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

Dental Caries Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03395496
Other study ID # 2017-24692
Secondary ID
Status Completed
Phase Early Phase 1
First received December 26, 2017
Last updated January 3, 2018
Start date May 1, 2013
Est. completion date May 30, 2016

Study information
Verified date January 2018
Source Istanbul University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 200
Est. completion date May 30, 2016
Est. primary completion date May 1, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 7 Years to 15 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Biodentine
Biodentine pulpotomy agent
• ProRoot (Aggregate)
ProRoot MTA pulpotomy agent

Locations
Country Name City State
Turkey Istanbul University Istanbul

Sponsors (1)
Lead Sponsor Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Other Total success rate 36 months after pulpotomy treatment
Primary Total success rate 12 months after pulpotomy treatment
Secondary Total success rate 24 months after pulpotomy treatment
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