NCT04018716

Clinical Performance of MTA Cavity Lining in the Treatment of Deep Caries Lesions

Clinical Performance of MTA Cavity Lining in the Treatment of Deep Caries Lesions: A 4- Year Randomized Controlled Clinical Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 73 (estimated)
• Sponsor: Hacettepe University · Academic / Other
• Sex: All
• Age: 18 Years – 30 Years
• Healthy volunteers: Accepted

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 (Ca(OH)2) (Dycal, Dentsply/Caulk, 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 (Ca(OH)2) 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 (Ca(OH)2) (Dycal, Dentsply/Caulk, 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 \< 0.05). The Kaplan-Meier survival analysis will be conducted to reveal the survival rate.

Conditions

• Mineral Trioxide Aggregate
• Calcium Hydroxide
• Indirect Pulp Capping

Interventions

Type	Name	Description
DEVICE	MTA	Indirect capping with MTA
DEVICE	Dycal	Indirect capping with Dycal

Timeline

• Start date: 2015-07-07
• Primary completion: 2016-01-07
• Completion: 2019-07-07
• First posted: 2019-07-12
• Last updated: 2019-07-16