MTA and Biodentine in Pulpotomized Primary Molars

This study is currently recruiting participants.

Verified February 2013 by Universitat Internacional de Catalunya

Sponsor:

Information provided by (Responsible Party):

Cristina Cuadros, Universitat Internacional de Catalunya

ClinicalTrials.gov Identifier:

NCT01591278

First received: April 30, 2012

Last updated: February 4, 2013

Last verified: February 2013

History of Changes

Purpose

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.

Condition	Intervention	Phase
Primary Molar Pulpotomy	Other: Pulpotomy	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Clinical and Radiographic Outcomes of MTA and Biodentine in Pulpotomized Primary Molars. A Randomized Clinical Trial

Further study details as provided by Universitat Internacional de Catalunya:

Primary Outcome Measures:

Number of molars with clinical success [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Number of molars with radiographic success [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Number of molars with no evidence of radicular radiolucency [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
Number of molars with no evidence of internal resorption [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
Number of molars with no evidence of external resorption [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
Number of molars with no evidence of furcation radiolucency [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
Number of molars with no symptoms of pain [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
Number of molars without swelling [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
Number of molars without fistulation [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
Number of molars without pathological mobility. [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	80
Study Start Date:	March 2012
Estimated Study Completion Date:	February 2014
Estimated Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Pulp dressing agent	Other: Pulpotomy Comparison of two different pulp dressing agents Other Name: Biodentine
Active Comparator: Pulp dressing MTA	Other: Pulpotomy Comparison of two different pulp dressing agents

Eligibility

Ages Eligible for Study:	4 Years to 9 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01591278

Locations

Spain
Universitat Internacional de Catalunya	Recruiting
Sant Cugat del Vallès, Barcelona, Spain, 08195
Contact: Cristina Cuadros, DDS 0034 935 042 000 cristinacuadros@hotmail.com
Principal Investigator: Cristina Cuadros, DDS

Sponsors and Collaborators

Cristina Cuadros

More Information

Publications:

Erdem AP, Guven Y, Balli B, Ilhan B, Sepet E, Ulukapi I, Aktoren O. Success rates of mineral trioxide aggregate, ferric sulfate, and formocresol pulpotomies: a 24-month study. Pediatr Dent. 2011 Mar-Apr;33(2):165-70.

Laurent P, Camps J, About I. Biodentine(TM) induces TGF-β1 release from human pulp cells and early dental pulp mineralization. Int Endod J. 2012 May;45(5):439-48. doi: 10.1111/j.1365-2591.2011.01995.x. Epub 2011 Dec 22.

Nadin G, Goel BR, Yeung CA, Glenny AM. Pulp treatment for extensive decay in primary teeth. Cochrane Database Syst Rev. 2003;(1):CD003220. Review.

Ansari G, Ranjpour M. Mineral trioxide aggregate and formocresol pulpotomy of primary teeth: a 2-year follow-up. Int Endod J. 2010 May;43(5):413-8.

Doyle TL, Casas MJ, Kenny DJ, Judd PL. Mineral trioxide aggregate produces superior outcomes in vital primary molar pulpotomy. Pediatr Dent. 2010 Jan-Feb;32(1):41-7.

Responsible Party:	Cristina Cuadros, Cristina Cuadros Fernández, Universitat Internacional de Catalunya
ClinicalTrials.gov Identifier:	NCT01591278 History of Changes
Other Study ID Numbers:	UIC-ODP-1
Study First Received:	April 30, 2012
Last Updated:	February 4, 2013
Health Authority:	Spain: Comité Ético de Investigación Clínica

ClinicalTrials.gov processed this record on June 17, 2013

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