Ignite Creation Date:
2024-05-05 @ 5:32 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00472173
Status:
COMPLETED
Last Update Posted:
2011-11-10
First Post:
2007-05-10
Brief Title:
Assessment of a New Apexification Method for Patients Presenting a Non Vital Immature Tooth
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Assessment of a New Apexification Method for Patients Presenting a Non Vital Immature Tooth
Status:
COMPLETED
Status Verified Date:
2011-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
APEXMTA
Brief Summary:
Pulp necrosis is one of the main complication of dental trauma When it happens on an immature tooth pulp necrosis implies a lack of root maturation and apical closure A therapy called apexification is required to induce the formation of a calcified apical barrier allowing a permanent and hermetic root fillingThe aim of this study is to compare the efficacy of a new apexification method using Mineral Trioxide Aggregate MTA with the reference treatment based on calcium hydroxide repeated stimulations
Detailed Description:
36 patients aged 6 to 18 and presenting a non vital immature tooth will be included in the study inclusion period 12 months These patients will be randomly divided into two groups one treated with MTA and the other one with calcium hydroxide For each patient the total duration of the study will be 12 months Recalls will be performed at 15 and 21 days and then at 3 6 and 12 months to assess by clinical and X-ray exams the main success criterion presence of a calcified apical barrier or not Additional criterions such as presence of clinical symptoms or not apical morphology and depth of this apical barrier will be observed This randomised prospective therapeutic study will allow to assess the ability of MTA inducing apexification of a non vital immature tooth Furthermore it will be possible to compare for both materials the kinetics of clinical symptoms disappearance and the morphology and depth of apices
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None