Clinical Performance of MTA Cavity Lining in the Treatmen... | NCT04018716

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

NCT04018716

Sponsor

Hacettepe University

Status

Unknown status

Last Update Posted

Jul 16, 2019Actual

Enrollment

73Estimated

Phase

Not Applicable

Conditions

Mineral Trioxide Aggregate
Calcium Hydroxide
Indirect Pulp Capping

Interventions

MTA
Dycal

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 7, 2015Actual

Primary Completion Date

Jan 7, 2016Actual

Completion Date

Jul 7, 2019Estimated

First Submitted Date

Jul 9, 2019

First Submission Date that Met QC Criteria

Jul 11, 2019

First Posted Date

Jul 12, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 12, 2019

Last Update Posted Date

Jul 16, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 (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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

73Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MTA	Experimental	mineral trioxide aggregate	Device: MTA
Dycal	Active Comparator	calcium hydroxide cement	Device: Dycal

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MTA	Device	Indirect capping with MTA	MTA
Dycal

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Primary deep caries lesion with risk of pulp exposure (radiograph depth reaching 3/4 of the dentin).
Restorable by direct restoration and functional permanent posterior teeth,
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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

30 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided