MTA and Biodentine in Pulpotomized Primary Molars

Phase 4

• Conditions: Primary Molar Pulpotomy
• Interventions: Other: Pulpotomy

• Registration Number: NCT01591278
• Lead Sponsor: Cristina Cuadros

Brief Summary

The objective of the study is to evaluate and compare, clinically and radiographically,the effects of MTA and Biodentine when used as pulp dressings following pulpotomy in human primary molars.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-04-30
• Study First Submitted QC: 2012-05-01
• Study First Posted: 2012-05-03
• Primary Completion: 2014-02
• Status Verified: 2014-11
• Study Completion: 2014-11
• Last Update Submitted: 2014-11-11
• Last Update Posted: 2014-11-13

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• molars showing:

  1. symptomless exposure of vital pulp by caries
  2. no clinical or radiographic evidence of pulp degeneration (excessive bleeding from the root canal, internal root resorption, inter-radicular and/or furcal bone destruction)
  3. the possibility of proper restoration of the teeth
  4. no physiological resorption of more than one-third of the root

Exclusion Criteria

• presence of systemic pathology and any history of allergic reaction to latex, local anaesthetics or to the constituents of the test pulp dressing agents

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pulp dressing	Pulpotomy	MTA
Pulp dressing agent	Pulpotomy	-

Primary Outcome Measures

Name	Time	Method
Number of molars with clinical success	12 months
Number of molars with radiographic success	6 and 12 months

Secondary Outcome Measures

Name	Time	Method
Number of molars with no evidence of radicular radiolucency	6 and 12 months
Number of molars with no evidence of internal resorption	6 and 12 months
Number of molars with no evidence of external resorption	6 and 12 months
Number of molars with no evidence of furcation radiolucency	6 and 12 months
Number of molars with no symptoms of pain	6 and 12 months
Number of molars without swelling	6 and 12 months
Number of molars without fistulation	6 and 12 months
Number of molars without pathological mobility.	6 and 12 months

Trial Locations

Locations (1)

Universitat Internacional de Catalunya; 🇪🇸 Sant Cugat del Vallès, Barcelona, Spain