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Completed

NCT Number: NCT03395496

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

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.

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Key information

Conditions

Pulpotomy Dental Caries Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

7 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Istanbul University

Istanbul, 34093, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Biodentine

Drug

Biodentine pulpotomy agent

Other names: 77509635

ProRoot (Aggregate)

Drug

ProRoot MTA pulpotomy agent

Other names: 75896452

Primary outcomes

  1. Total success rate

    Time frame: 12 months after pulpotomy treatment

Secondary outcomes

  1. Total success rate

    Time frame: 24 months after pulpotomy treatment

Other outcomes

  1. Total success rate

    Time frame: 36 months after pulpotomy treatment

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jan 10, 2018
Registry last updated
Jan 10, 2018

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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