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

Indirect Pulp Capping Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04018716
• Other study ID #: HEK 11/106
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 7, 2015
• Est. completion date: July 7, 2019

Study information

• Verified date: July 2019
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 73
• Est. completion date: July 7, 2019
• Est. primary completion date: January 7, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

Inclusion Criteria:

1. Primary deep caries lesion with risk of pulp exposure (radiograph depth reaching 3/4 of the dentin).

2. Restorable by direct restoration and functional permanent posterior teeth,

3. Positive response to electric pulp testing and negative response to thermal testing.

Exclusion Criteria:

1. Two or more cuspal loss 2. Caries beneath the gingival margin 3. Spontaneous pain history 4. Presence of any periapical pathology 5. Immature teeth with open apex 6. Pathologic mobility

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Related Conditions & MeSH terms

• Calcium Hydroxide
• Indirect Pulp Capping
• Mineral Trioxide Aggregate

Intervention

Device:
• MTA
Indirect capping with MTA
• Dycal
Indirect capping with Dycal

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluating of clinical success of restorations	The treatment consequence was judged as "clinically successful" when the following criteria were met: positive response to electric pulp testing, negative response to cold stimuli by air-water shrinkage, no general pain, normal response to tactile tests or triggered pain not lingering, no evidence of abscess, sinus tract and no abnormal tooth mobility. These teeth were considered to be "clinically healthy" and the treatment was successful.	6 months