Resin Infiltration to Arrest Early Tooth Decay

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2017-12-31

Brief Summary

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The purpose of this study is to determine whether lesion infiltration is an effective management strategy to arrest early tooth decay.

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Detailed Description

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A 3-year prospective, randomized control clinical trial (RCT) is designed incorporating a split mouth intra-oral design. Young volunteers (18-24 years old) with at least two early lesions in posterior teeth will be enrolled into this clinical trial to evaluate the clinical effectiveness of arresting lesion progression by resin infiltration therapy as adjunct to standard-of-care preventative measures. Lesion status (non-cavitated) is clinically confirmed prior to implementing the assigned therapy.

Conditions

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Dental Caries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Resin infiltration

Resin infiltration of early caries lesion in addition to preventative measures (oral hygiene, diet counseling, repeated fluoride varnish application)

Group Type ACTIVE_COMPARATOR

Resin infiltration

Intervention Type DEVICE

Baseline treatment of one caries lesion with resin infiltration therapy, in addition to preventative measures and behavioral modification.

ICON product: FDA-510(k): K100062

Control

Sham treatment of early caries lesion in addition to preventative measures (oral hygiene, diet counseling, repeated fluoride varnish application)

Group Type SHAM_COMPARATOR

Sham treatment

Intervention Type DEVICE

Baseline treatment of one caries lesion with sham treatment, in addition to preventative measures and behavioral modification.

Interventions

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Resin infiltration

Baseline treatment of one caries lesion with resin infiltration therapy, in addition to preventative measures and behavioral modification.

ICON product: FDA-510(k): K100062

Intervention Type DEVICE

Sham treatment

Baseline treatment of one caries lesion with sham treatment, in addition to preventative measures and behavioral modification.

Intervention Type DEVICE

Other Intervention Names

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ICON Infiltration kit (DMG, Germany) (ICON=product name)

Eligibility Criteria

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Inclusion Criteria

* DMFT ≥ 3 (DMFT = index of decayed-missing-filled permanent teeth)
* Having at least two early caries lesions in approximal posterior tooth surfaces
* Lesions visible on radiograph

Exclusion Criteria

* Current participation in another clinical study
* Medically compromised subjects
* Hyposalivation
* Pregnancy
* Allergic to methylmethacrylates
* Allergic to latex
* Symptomatic teeth

Minimum Eligible Age

18 Years

Maximum Eligible Age

24 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No