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Digital Subtraction Radiography Evaluation of SMART Restoration With Partial Caries Removal in Primary Teeth

NCT ID: NCT01749267

Last Updated: 2012-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2010-09-30

Brief Summary

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The objective of this study was to analyze the radiographic density of digital subtraction radiographs after SMART restoration with partial caries removal in primary molars at 6 and 12 months.

Detailed Description

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In management of deep caries in primary teeth, the partial caries removal approach favored the arrest of dentin carious lesions, reduced cariogenic micro-organisms and the risk of pulp exposure. The carious tissue at the lateral walls of the cavity at the enamel dentin junction (EDJ) was removed by a spoon excavator without carious tissue removal at the pulpal site. After caries removal, restoration using glass ionomer cement (GIC)(GC Fuji IX™GP extra) was completed. Such an approach is called SMART restoration. The serial radiographs of each restoration consisted of three radiographs; immediately after restoration, at the 6-month follow-up and at the 12-month follow-ups. Digital subtraction radiography(DSR) was used to evaluate dentin remineralization following partial caries removal. Image-Pro Plus software was used to evaluate DSR. For evaluating the changes in DSR, areas with increase density show higher radiopacity, whereas areas with decreased density show higher radiolucency. The 6-month and 12-month follow-up radiographs were subtracted from the baseline radiograph.

Conditions

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Dental Caries Extending Into Dentine

Keywords

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dentin remineralization caries regression

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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partial caries removal

partial caries removal only at enamel dentin junction (EDJ) without carious tissue removal at the pulpal site

Group Type EXPERIMENTAL

partial caries removal only at enamel dentin junction.

Intervention Type PROCEDURE

Partial caries removal only at enamel dentin junction (EDJ) without carious dentin removal at the pulpal site and restoration with glass ionomer cement(SMART restoration)

Interventions

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partial caries removal only at enamel dentin junction.

Partial caries removal only at enamel dentin junction (EDJ) without carious dentin removal at the pulpal site and restoration with glass ionomer cement(SMART restoration)

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Presence of teeth with dentinal caries limited to the occlusal and proximal surfaces without clinical signs and symptoms of irreversible pulpitis (spontaneous pain, sinus opening, or abnormal tooth mobility
* The radiographic examination showing dental caries involving not less than half of the dentin without any pathologic findings (external root resorption, internal root resorption, abnormality of root resorption, or radiolucency area at furcation /periapical regions).

Exclusion Criteria

* Teeth with caries exposure to pulp
Minimum Eligible Age

6 Years

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mahidol University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Araya Phonghanyudh, PhD

Role: STUDY_DIRECTOR

Locations

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Mahidol University

Bangkok, Bangkok, Thailand

Site Status

Countries

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Thailand

References

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Phonghanyudh A, Phantumvanit P, Songpaisan Y, Petersen PE. Clinical evaluation of three caries removal approaches in primary teeth: a randomised controlled trial. Community Dent Health. 2012 Jun;29(2):173-8.

Reference Type BACKGROUND
PMID: 22779380 (View on PubMed)

Related Links

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http://www.ncbi.nlm.nih.gov/pubmed/22779380

Clink here for more information about this study:http://www.ncbi.nlm.nih.gov/pubmed?term=clinical evaluation of three caries removal approaches in primary teeth

Other Identifiers

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Faculty of Dentistry

Identifier Type: -

Identifier Source: org_study_id