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

Early Phase 1

Completed

• Conditions: Pulpotomy; Dental Caries
• Interventions: Drug: Biodentine; Drug: ProRoot (Aggregate)

• Registration Number: NCT03395496
• Lead Sponsor: Istanbul University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05-01
• Primary Completion: 2016-05-01
• Study Completion: 2016-05-30
• Study First Submitted: 2017-12-26
• Status Verified: 2018-01
• Study First Submitted QC: 2018-01-03
• Last Update Submitted: 2018-01-03
• Study First Posted: 2018-01-10
• Last Update Posted: 2018-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Biodentine	Biodentine	Dental materials
ProRoot MTA	ProRoot (Aggregate)	Dental Materials
Biodentine	ProRoot (Aggregate)	Dental materials
ProRoot MTA	Biodentine	Dental Materials

Primary Outcome Measures

Name	Time	Method
Total success rate	12 months after pulpotomy treatment

Secondary Outcome Measures

Name	Time	Method
Total success rate	24 months after pulpotomy treatment

Trial Locations

Locations (1)

Istanbul University; 🇹🇷 Istanbul, Turkey