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

Not Applicable

Completed

• Conditions: Dental Caries Extending Into Dentine
• Interventions: Procedure: partial caries removal only at enamel dentin junction.

• Registration Number: NCT01749267
• Lead Sponsor: Mahidol University

Brief Summary

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

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.

Study Timeline

• Status Verified: 2010-09
• Study Start: 2010-09
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Study First Submitted: 2012-12-11
• Study First Submitted QC: 2012-12-11
• Last Update Submitted: 2012-12-11
• Study First Posted: 2012-12-13
• Last Update Posted: 2012-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
dentin remineralization	12 months	Dentin remineralization was evaluated using Digital subtraction radiography (DSR).

Trial Locations

Locations (1)

Mahidol University; 🇹🇭 Bangkok, Thailand