Comparison of The Success Rates of Four Different Pulpotomy Techniques

Phase 3

Completed

• Conditions: Extensive Decay in Primary Molars
• Interventions: Drug: ProRoot (Aggregate); Drug: MTA Plus; Drug: Ferric Sulfate 20 % Dental Gel; Drug: Biodentine

• Registration Number: NCT03135626
• Lead Sponsor: Istanbul University

Brief Summary

This randomized clinical trial was conducted to examine and compare the effectiveness of pulpotomy in primary molars treated with calcium silicate based materials including Biodentine and two different mineral trioxide aggregate (MTA) products (white ProRoot® MTA and MTA Plus®). Ferric sulfate pulpotomy was selected to represent the control group. 116 primary molars in 29 children were treated by pulpotomy and followed for a period of 24 months.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03-15
• Primary Completion: 2014-01-15
• Study Completion: 2016-02-15
• Status Verified: 2017-04
• Study First Submitted: 2017-04-26
• Study First Submitted QC: 2017-04-28
• Last Update Submitted: 2017-04-28
• Study First Posted: 2017-05-01
• Last Update Posted: 2017-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

• Patients were eligible if they were 5 to 7 years old, healthy and cooperative, and had at least four carious primary molars, each of which was in a different quadrant and required a pulpotomy. The criteria for the selection of the teeth to be included in the study were presence of deep caries, presence of at least two-thirds of the root length radiographically and being restorable.

Exclusion Criteria

• The exclusion criteria were the presence of 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) space, furcal or periapical radiolucency and teeth requiring more than 5 minutes to achieve hemostasis during clinical procedure. Teeth without permanent successor were not also included in the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ProRoot MTA	ProRoot (Aggregate)	ProRoot MTA pulpotomy agent
MTA Plus	MTA Plus	MTA Plus pulpotomy agent
Ferric Sulfate 20% Dental Gel	Ferric Sulfate 20 % Dental Gel	Ferric Sulfate %20 Dental Gel pulpotomy agent
Biodentine	Biodentine	Biodentine pulpotomy agent

Primary Outcome Measures

Name	Time	Method
Total success rate	24 months after pulpotomy treatment	Number of molars with both clinically and radiographically successful