Ignite Creation Date:
2024-05-06 @ 1:24 PM
Last Modification Date:
2024-10-26 @ 1:14 PM
Study NCT ID:
NCT04018716
Status:
UNKNOWN
Last Update Posted:
2019-07-16
First Post:
2019-07-09
Brief Title:
Clinical Performance of MTA Cavity Lining in the Treatment of Deep Caries Lesions
Sponsor:
Hacettepe University
Organization:
Hacettepe University
Study Overview
Official Title:
Clinical Performance of MTA Cavity Lining in the Treatment of Deep Caries Lesions A 4- Year Randomized Controlled Clinical Trial
Status:
UNKNOWN
Status Verified Date:
2019-07
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
None
Brief Summary:
Aim of this clinical study is to compare the clinical success of two lining materials regarding the maintenance of pulp vitality in the treatment of deep caries lesions over 4- years
A hundred permanent premolar and molars with deep caries lesions without pulp involvement aged between 18 and 30 years in 73 patients were randomly divided into the following groups calcium hydroxide cement CaOH2 Dycal DentsplyCaulk Dentsply International Inc Milford DE USA group and mineral trioxide aggregate MTA Dentsplay Tulsa Dental Johnson city USA group Final restoration with a resin-based composite Gradia Direct Posterior GC Tokyo Japan in a single session was performed The following-up period was 6- 12- 24- 36- and 48-months Two calibrated examiners performed the clinical examination of the pulpal symptoms
A hundred permanent premolar and molars with deep caries lesions without pulp involvement aged between 18 and 30 years in 73 patients were randomly divided into the following groups calcium hydroxide cement CaOH2 Dycal DentsplyCaulk Dentsply International Inc Milford DE USA group and mineral trioxide aggregate MTA Dentsplay Tulsa Dental Johnson city USA group Final restoration with a resin-based composite Gradia Direct Posterior GC Tokyo Japan in a single session was performed The following-up period was 6- 12- 24- 36- and 48-months Two calibrated examiners performed the clinical examination of the pulpal symptoms
Detailed Description:
Aim of this clinical study is to compare the clinical outcomes of mineral trioxide aggregate MTA cavity lining with calcium hydroxide CaOH2 regarding the maintenance of pulp vitality in the treatment of deep caries lesions over 4- years
Materials and Methods A hundred permanent premolar and molars with deep caries lesions without pulp involvement aged between 18 and 30 years in 73 patients were randomly divided into the following groups calcium hydroxide cement CaOH2 Dycal DentsplyCaulk Dentsply International Inc Milford DE USA group and mineral trioxide aggregate MTA Dentsplay Tulsa Dental Johnson city USA group Final restoration with a resin-based composite Gradia Direct Posterior GC Tokyo Japan in a single session was performed The following-up period was 6- 12- 24- 36- and 48-months Two calibrated examiners performed the clinical examination of the pulpal symptoms The data will be analyzed with Pearson chi-square Fisher exact and logrank statistics tests p 005 The Kaplan-Meier survival analysis will be conducted to reveal the survival rate
Materials and Methods A hundred permanent premolar and molars with deep caries lesions without pulp involvement aged between 18 and 30 years in 73 patients were randomly divided into the following groups calcium hydroxide cement CaOH2 Dycal DentsplyCaulk Dentsply International Inc Milford DE USA group and mineral trioxide aggregate MTA Dentsplay Tulsa Dental Johnson city USA group Final restoration with a resin-based composite Gradia Direct Posterior GC Tokyo Japan in a single session was performed The following-up period was 6- 12- 24- 36- and 48-months Two calibrated examiners performed the clinical examination of the pulpal symptoms The data will be analyzed with Pearson chi-square Fisher exact and logrank statistics tests p 005 The Kaplan-Meier survival analysis will be conducted to reveal the survival rate
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None