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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01749267
First Posted: December 13, 2012
Last Update Posted: December 13, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Mahidol University
  Purpose
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.

Condition Intervention
Dental Caries Extending Into Dentine Procedure: partial caries removal only at enamel dentin junction.

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical and Digital Subtraction Radiography Evaluation of Partial Caries Removal in Primary Teeth

Resource links provided by NLM:


Further study details as provided by Mahidol University:

Primary Outcome Measures:
  • dentin remineralization [ Time Frame: 12 months ]
    Dentin remineralization was evaluated using Digital subtraction radiography (DSR).


Enrollment: 38
Study Start Date: September 2010
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: partial caries removal
partial caries removal only at enamel dentin junction (EDJ) without carious tissue removal at the pulpal site
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)

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01749267


Locations
Thailand
Mahidol University
Bangkok, Thailand, 10400
Sponsors and Collaborators
Mahidol University
Investigators
Study Director: Araya Phonghanyudh, PhD
  More Information

Additional Information:
Publications:
Responsible Party: Mahidol University
ClinicalTrials.gov Identifier: NCT01749267     History of Changes
Other Study ID Numbers: Faculty of Dentistry
First Submitted: December 11, 2012
First Posted: December 13, 2012
Last Update Posted: December 13, 2012
Last Verified: September 2010

Keywords provided by Mahidol University:
dentin remineralization
caries regression

Additional relevant MeSH terms:
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases