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

Dental Caries Extending Into Dentine Clinical Trial

— DSR  

Official title:

Clinical and Digital Subtraction Radiography Evaluation of Partial Caries Removal in Primary Teeth

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01749267
• Other study ID #: Faculty of Dentistry
• Status: Completed
• Phase: N/A
• First received: December 11, 2012
• Last updated: December 11, 2012
• Start date: September 2010
• Est. completion date: September 2010

Study information

• Verified date: September 2010
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 8 Years

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dental Caries
• Dental Caries Extending Into Dentine

Intervention

Procedure:
• 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)

Locations

Country	Name	City	State
Thailand	Mahidol University	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	dentin remineralization	Dentin remineralization was evaluated using Digital subtraction radiography (DSR).	12 months	No

External Links

•   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