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OpenTrials
Completed

NCT Number: NCT03135626

Comparison of The Success Rates of Four Different Pulpotomy Techniques

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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Key information

Conditions

Extensive Decay in Primary Molars

Age range

5 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Biodentine

Drug

Other names: 77509635

ProRoot (Aggregate)

Drug

Other names: 75896452

MTA Plus

Drug

Other names: 85303191

Ferric Sulfate 20 % Dental Gel

Drug

Other names: Viscostat

Primary outcomes

  1. Total success rate

    Time frame: 6 months after pulpotomy treatment

    Number of molars with both clinically and radiographically successful

  2. Total success rate

    Time frame: 12 months after pulpotomy treatment

    Number of molars with both clinically and radiographically successful

  3. Total success rate

    Time frame: 24 months after pulpotomy treatment

    Number of molars with both clinically and radiographically successful

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2016
First posted
May 1, 2017
Registry last updated
May 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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