NCT01749267

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

December 11, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 13, 2012

Completed
Last Updated

December 13, 2012

Status Verified

September 1, 2010

Enrollment Period

Same day

First QC Date

December 11, 2012

Last Update Submit

December 11, 2012

Conditions

Dental Caries Extending Into Dentine

Keywords

dentin remineralizationcaries regression

Outcome Measures

Primary Outcomes (1)

  • dentin remineralization

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

    12 months

Study Arms (1)

partial caries removal

EXPERIMENTAL

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.

Interventions

partial caries removal only at enamel dentin junction.PROCEDURE

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)

partial caries removal

Eligibility Criteria

Age6 Years - 8 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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).

You may not qualify if:

  • Teeth with caries exposure to pulp

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mahidol University

Bangkok, Bangkok, 10400, Thailand

Location

Related 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.

    PMID: 22779380BACKGROUND

Related Links

Study Officials

  • Araya Phonghanyudh, PhD

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 11, 2012

First Posted

December 13, 2012

Study Start

September 1, 2010

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

December 13, 2012

Record last verified: 2010-09

Locations

TH(1)