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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mahidol University
ClinicalTrials.gov Identifier:
NCT01749267
First received: December 11, 2012
Last updated: NA
Last verified: September 2010
History: No changes posted
  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: 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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   6 Years to 8 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: December 11, 2012
Last Updated: December 11, 2012
Health Authority: Thailand: Ethical Committee

Keywords provided by Mahidol University:
dentin remineralization
caries regression

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

ClinicalTrials.gov processed this record on April 17, 2014