Comparison of The Success Rates of Four Different Pulpotomy Techniques

Istanbul University

Status and phase: Completed; Phase 3

Conditions: Extensive Decay in Primary Molars

Treatments: Drug: MTA Plus; Drug: ProRoot (Aggregate); Drug: Biodentine; Drug: Ferric Sulfate 20 % Dental Gel

Study type: Interventional

Funder types: Other

Identifiers

NCT03135626

2012/1728-1288

Details and patient eligibility

About

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.

Enrollment: 38 patients

Sex: All

Ages: 5 to 7 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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38 participants in 4 patient groups

Biodentine

Experimental group

Description:

Biodentine pulpotomy agent

Treatment:

Drug: Biodentine

ProRoot MTA

Experimental group

Description:

ProRoot MTA pulpotomy agent

Treatment:

Drug: ProRoot (Aggregate)

MTA Plus

Experimental group

Description:

MTA Plus pulpotomy agent

Treatment:

Drug: MTA Plus

Ferric Sulfate 20% Dental Gel

Active Comparator group

Description:

Ferric Sulfate %20 Dental Gel pulpotomy agent

Treatment:

Drug: Ferric Sulfate 20 % Dental Gel