Clinical trial NCT01591278: MTA and Biodentine in Pulpotomized Primary Molars
Official title: Clinical and Radiographic Outcomes of MTA and Biodentine in Pulpotomized Primary Molars. A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Primary Molar Pulpotomy
Lead sponsor: Universitat Internacional de Catalunya
Sponsor class: OTHER
First posted: 2012-05-03
Enrollment: 80
Sex: ALL
Minimum age (years): 4
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Number of molars with clinical success
timeFrame: 12 months
measure: Number of molars with radiographic success
timeFrame: 6 and 12 months
Secondary outcomes:
measure: Number of molars with no evidence of radicular radiolucency
timeFrame: 6 and 12 months
measure: Number of molars with no evidence of internal resorption
timeFrame: 6 and 12 months
measure: Number of molars with no evidence of external resorption
timeFrame: 6 and 12 months
measure: Number of molars with no evidence of furcation radiolucency
timeFrame: 6 and 12 months
measure: Number of molars with no symptoms of pain
timeFrame: 6 and 12 months
measure: Number of molars without swelling
timeFrame: 6 and 12 months
measure: Number of molars without fistulation
timeFrame: 6 and 12 months
measure: Number of molars without pathological mobility.
timeFrame: 6 and 12 months
Other outcomes:
Locations:
city: Sant Cugat del Vallès
country: Spain
facility: Universitat Internacional de Catalunya
state: Barcelona
Study officials:
References:
citation: 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.
citation: Laurent P, Camps J, About I. Biodentine(TM) induces TGF-beta1 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.
citation: Nadin G, Goel BR, Yeung CA, Glenny AM. Pulp treatment for extensive decay in primary teeth. Cochrane Database Syst Rev. 2003;(1):CD003220. doi: 10.1002/14651858.CD003220.
citation: 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. doi: 10.1111/j.1365-2591.2010.01695.x.
citation: 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.