MTA and Biodentine in Pulpotomized Primary Molars

Primary Molar Pulpotomy Clinical Trial

Official title:

Clinical and Radiographic Outcomes of MTA and Biodentine in Pulpotomized Primary Molars. A Randomized Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01591278
• Other study ID #: UIC-ODP-1
• Status: Active, not recruiting
• Phase: Phase 4
• First received: April 30, 2012
• Last updated: November 11, 2014
• Start date: March 2012
• Est. completion date: November 2014

Study information

• Verified date: November 2014
• Source: Universitat Internacional de Catalunya
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: November 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 9 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Primary Molar Pulpotomy

Intervention

Other:
• Pulpotomy
Comparison of two different pulp dressing agents
• Pulpotomy
Comparison of two different pulp dressing agents

Locations

Country	Name	City	State
Spain	Universitat Internacional de Catalunya	Sant Cugat del Vallès	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Cristina Cuadros

Country where clinical trial is conducted

Spain, 

References & Publications (5)

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. — View 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. — View 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. — View Citation

Laurent P, Camps J, About I. Biodentine(TM) induces TGF-ß1 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. — View Citation

Nadin G, Goel BR, Yeung CA, Glenny AM. Pulp treatment for extensive decay in primary teeth. Cochrane Database Syst Rev. 2003;(1):CD003220. Review. Update in: Cochrane Database Syst Rev. 2014;8:CD003220. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of molars with clinical success		12 months	No
Primary	Number of molars with radiographic success		6 and 12 months	No
Secondary	Number of molars with no evidence of radicular radiolucency		6 and 12 months	No
Secondary	Number of molars with no evidence of internal resorption		6 and 12 months	No
Secondary	Number of molars with no evidence of external resorption		6 and 12 months	No
Secondary	Number of molars with no evidence of furcation radiolucency		6 and 12 months	No
Secondary	Number of molars with no symptoms of pain		6 and 12 months	No
Secondary	Number of molars without swelling		6 and 12 months	No
Secondary	Number of molars without fistulation		6 and 12 months	No
Secondary	Number of molars without pathological mobility.		6 and 12 months	No