NCT01591278

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2012

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 30, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 3, 2012

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

November 13, 2014

Status Verified

November 1, 2014

Enrollment Period

1.9 years

First QC Date

April 30, 2012

Last Update Submit

November 11, 2014

Conditions

Primary Molar Pulpotomy

Outcome Measures

Primary Outcomes (2)

  • Number of molars with clinical success

    12 months

  • Number of molars with radiographic success

    6 and 12 months

Secondary Outcomes (8)

  • 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

  • +3 more secondary outcomes

Study Arms (2)

Pulp dressing agent

EXPERIMENTAL
Other: Pulpotomy

Pulp dressing

ACTIVE COMPARATOR

MTA

Other: Pulpotomy

Interventions

PulpotomyOTHER

Comparison of two different pulp dressing agents

Pulp dressing

Eligibility Criteria

Age4 Years - 9 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitat Internacional de Catalunya

Sant Cugat del Vallès, Barcelona, 08195, Spain

Location

Related Publications (5)

  • 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.

    PMID: 21703067BACKGROUND

  • 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.

    PMID: 22188368BACKGROUND

  • 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.

    PMID: 12535462BACKGROUND

  • 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.

    PMID: 20518934BACKGROUND

  • 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.

    PMID: 20298652BACKGROUND

MeSH Terms

Interventions

Pulpotomytricalcium silicate

Intervention Hierarchy (Ancestors)

EndodonticsDentistry

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Cristina Cuadros Fernández

Study Record Dates

First Submitted

April 30, 2012

First Posted

May 3, 2012

Study Start

March 1, 2012

Primary Completion

February 1, 2014

Study Completion

November 1, 2014

Last Updated

November 13, 2014

Record last verified: 2014-11

Locations

ES(1)