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

Primary Purpose

Dental Caries Extending Into Dentine

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
partial caries removal only at enamel dentin junction.
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Caries Extending Into Dentine focused on measuring dentin remineralization, caries regression

Eligibility Criteria

6 Years - 8 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mahidol University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

partial caries removal

Arm Description

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

Outcomes

Primary Outcome Measures

dentin remineralization
Dentin remineralization was evaluated using Digital subtraction radiography (DSR).

Secondary Outcome Measures

Full Information

First Posted
December 11, 2012
Last Updated
December 11, 2012
Sponsor
Mahidol University
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1. Study Identification

Unique Protocol Identification Number
NCT01749267
Brief Title
Digital Subtraction Radiography Evaluation of SMART Restoration With Partial Caries Removal in Primary Teeth
Acronym
DSR
Official Title
Clinical and Digital Subtraction Radiography Evaluation of Partial Caries Removal in Primary Teeth
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mahidol University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries Extending Into Dentine
Keywords
dentin remineralization, caries regression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
partial caries removal
Arm Type
Experimental
Arm Description
partial caries removal only at enamel dentin junction (EDJ) without carious tissue removal at the pulpal site
Intervention Type
Procedure
Intervention Name(s)
partial caries removal only at enamel dentin junction.
Intervention Description
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)
Primary Outcome Measure Information:
Title
dentin remineralization
Description
Dentin remineralization was evaluated using Digital subtraction radiography (DSR).
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Araya Phonghanyudh, PhD
Official's Role
Study Director
Facility Information:
Facility Name
Mahidol University
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand

12. IPD Sharing Statement

Citations:
PubMed Identifier
22779380
Citation
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.
Results Reference
background
Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/22779380
Description
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

Learn more about this trial

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

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