Overview

This trial is active, not recruiting.

Condition primary molar pulpotomy
Treatments pulpotomy
Phase phase 4
Sponsor Cristina Cuadros
Start date March 2012
End date February 2014
Trial size 80 participants
Trial identifier NCT01591278, UIC-ODP-1

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
pulpotomy Biodentine
Comparison of two different pulp dressing agents
(Active Comparator)
MTA
pulpotomy
Comparison of two different pulp dressing agents

Primary Outcomes

Measure
Number of molars with clinical success
time frame: 12 months
Number of molars with radiographic success
time frame: 6 and 12 months

Secondary Outcomes

Measure
Number of molars with no evidence of radicular radiolucency
time frame: 6 and 12 months
Number of molars with no evidence of internal resorption
time frame: 6 and 12 months
Number of molars with no evidence of external resorption
time frame: 6 and 12 months
Number of molars with no evidence of furcation radiolucency
time frame: 6 and 12 months
Number of molars with no symptoms of pain
time frame: 6 and 12 months
Number of molars without swelling
time frame: 6 and 12 months
Number of molars without fistulation
time frame: 6 and 12 months
Number of molars without pathological mobility.
time frame: 6 and 12 months

Eligibility Criteria

Male or female participants from 4 years up to 9 years old.

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

Additional Information

Official title Clinical and Radiographic Outcomes of MTA and Biodentine in Pulpotomized Primary Molars. A Randomized Clinical Trial
Trial information was received from ClinicalTrials.gov and was last updated in November 2014.
Information provided to ClinicalTrials.gov by Universitat Internacional de Catalunya.