Comparison of The Success Rates of Four Different Pulpotomy Techniques

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-15

Study Completion Date

2016-02-15

Brief Summary

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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.

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Detailed Description

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Conditions

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Extensive Decay in Primary Molars

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Split-mouth study design was used

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Biodentine

Biodentine pulpotomy agent

Group Type EXPERIMENTAL

Biodentine

Intervention Type DRUG

ProRoot MTA

ProRoot MTA pulpotomy agent

Group Type EXPERIMENTAL

ProRoot (Aggregate)

Intervention Type DRUG

MTA Plus

MTA Plus pulpotomy agent

Group Type EXPERIMENTAL

MTA Plus

Intervention Type DRUG

Ferric Sulfate 20% Dental Gel

Ferric Sulfate %20 Dental Gel pulpotomy agent

Group Type ACTIVE_COMPARATOR

Ferric Sulfate 20 % Dental Gel

Intervention Type DRUG

Interventions

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Biodentine

Intervention Type DRUG

ProRoot (Aggregate)

Intervention Type DRUG

MTA Plus

Intervention Type DRUG

Ferric Sulfate 20 % Dental Gel

Intervention Type DRUG

Other Intervention Names

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77509635 75896452 85303191 Viscostat

Eligibility Criteria

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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.

Minimum Eligible Age

5 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No