MTA and Biodentine in Pulpotomized Primary Molars

NCT ID: NCT01591278

Last Updated: 2014-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2014-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Primary Molar Pulpotomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Pulp dressing agent

Group Type EXPERIMENTAL

Pulpotomy

Intervention Type OTHER

Comparison of two different pulp dressing agents

Pulp dressing

MTA

Group Type ACTIVE_COMPARATOR

Pulpotomy

Intervention Type OTHER

Comparison of two different pulp dressing agents

Interventions

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Pulpotomy

Comparison of two different pulp dressing agents

Intervention Type OTHER

Pulpotomy

Comparison of two different pulp dressing agents

Intervention Type OTHER

Other Intervention Names

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Biodentine

Eligibility Criteria

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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
Minimum Eligible Age

4 Years

Maximum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cristina Cuadros

OTHER

Sponsor Role lead

Responsible Party

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Cristina Cuadros

Cristina Cuadros Fernández

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Universitat Internacional de Catalunya

Sant Cugat del Vallès, Barcelona, Spain

Site Status

Countries

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Spain

References

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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.

Reference Type BACKGROUND
PMID: 21703067 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22188368 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12535462 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20518934 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20298652 (View on PubMed)

Other Identifiers

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UIC-ODP-1

Identifier Type: -

Identifier Source: org_study_id