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Clinical Trial Proximal Caries Infiltration and Detection

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2014 by DMG Dental Material Gesellschaft mbH
Sponsor:
Information provided by (Responsible Party):
DMG Dental Material Gesellschaft mbH
ClinicalTrials.gov Identifier:
NCT01796106
First received: November 1, 2012
Last updated: June 20, 2014
Last verified: June 2014
  Purpose

The goal of the project is to investigate the clinical efficacy of management of early caries lesions by resin infiltration, which may be imaged through a SFE laser optical device comparable to radiographic results.


Condition Intervention
Caries
Device: Icon
Device: fluoride varnish

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Clinical Efficacy of Caries Infiltration (Icon) - A Randomized, Blinded and Controlled Pilot Study of Early Caries Progression Detection

Resource links provided by NLM:


Further study details as provided by DMG Dental Material Gesellschaft mbH:

Primary Outcome Measures:
  • Caries arrest after Icon treatment evaluated by bitewing radiographs [ Time Frame: 1 yr and 2 yrs ] [ Designated as safety issue: No ]
    We propose a randomized, blinded, clinical study of Icon vs. Control (Oral Hygiene Instruction [OHI] and topical fluoridation) as early caries interventions for caries arrest in pediatric populations. 50 participants with 2 or more active, non-cavitated early caries lesions, or areas of demineralization, in proximal surfaces of primary molars will be enrolled in this study. Early caries lesions with demineralization seen on occlusal surfaces will be excluded from participation, along with white spot lesions from hypoplasia or fluorosis.


Secondary Outcome Measures:
  • quantified results from primary endpoint may also visualized by SFE [ Time Frame: 1 yr and 2 yrs ] [ Designated as safety issue: No ]
    Currently no single method for caries detection can be used on all tooth surfaces under all conditions. These diagnostic devices and methods lack sensitivity and specificity; with caries detection at a point when surgical or restorative intervention is required. Additionally, these optical imaging devices are cumbersome, and often lead to inaccuracy due to user failure. Ultimately, these approaches result in caries lesions diagnoses overlooked at the earliest stages when less invasive measures, including remineralization techniques such as Icon, may be effective. Clinical caries detection sensitive to early lesions would bring about innovations in treatment modalities through medicinal therapeutic and preventive approaches, including chemotherapeutic approaches such as Icon. An imaging system such as the SFE optical device, specifically designed for dentistry, would be the ideal approach.


Estimated Enrollment: 50
Study Start Date: August 2014
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Icon
The study clinician will provide Icon treatment to all study participants randomized to study arm 1 after the radiograph and visual exam.
Device: Icon
refer to instructions for use of Icon
Active Comparator: control
The study clinician will provide oral hygiene instruction and topical fluoridation therapy (Duraphat fluoride varnish) to all study participants randomized to study arm 2 after the radiograph and visual exam.
Device: fluoride varnish
The study clinician will provide oral hygiene instruction and topical fluoridation therapy (Duraphat fluoride varnish; Colgate Oral Pharmaceuticals, New York, NY, United States) to all study participants randomized to study arm 2 after the radiograph and visual exam. Topical fluoridation treatment will be provided is varnish (Duraphat) per manufacturer's instructions.
Other Name: Duraphat fluoride varnish

Detailed Description:

Objective: The hypothesis to be tested is that Icon performs similarly to an established prevention strategy for early caries (Oral hygiene instruction and topical fluoridation) for caries arrest; and caries progression may be imaged through a SFE laser optical device.

Materials and Methods: The investigators propose a pilot study of Icon vs. control including Oral Hygiene Instructions (OHI) and topical fluoridation for early caries arrest in primary molars. Lesion depth will be performed through standard-of care methods, i.e. radiographs and visual exams, plus a novel optical device based on scanning fiber endoscope (SFE) technology for laser light imaging for early caries detection in pediatric populations. The investigators will utilize SFE laser optical device prototypes developed by the University of Washington's Human Photonics Lab (HPL), a device already in human use for other applications, including imaging and cancer screening.

Clinical Significance: This controlled trial will assess the positive effects of white spot infiltration by ICON and may open a new therapeutic strategy in paediatric dentistry. Additionally, this study would be one of the first in vivo dental applications of the SFE optical device, and would add a novel early caries visualization technique to the armamentarium for detecting caries progression.

  Eligibility

Ages Eligible for Study:   6 Years to 13 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children in age from 6-13 years
  • minimum of 2 early caries lesions present in primary molars

Criteria used to assess teeth for acceptance into this study include:

  1. teeth fully erupted, in functional occlusion and
  2. radiographic evidence of early caries in interproximal areas - good general health and free of any systemic disease or disability

Exclusion Criteria:

  • when currently enrolled in a study that includes evaluation of other restorative materials or systems involving posterior teeth
  • documented history of any adverse reaction to clinical materials
  • Patients refusing radiograph exam
  • pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01796106

Contacts
Contact: Joel Berg, DDS, MS (206) 543-6695 joelberg@uw.edu
Contact: Amy Kim, DDS (206) 543-0407 Akim3@uw.edu

Locations
United States, Washington
The Center for Pediatric Dentistry Not yet recruiting
Seattle, Washington, United States, 98115
Contact: Joel Berg, DDS, MS    206-543-6695    joelberg@uw.edu   
Principal Investigator: Joel Berg, DDS,MS         
Sub-Investigator: Amy Kim, DDS         
Sub-Investigator: Travis Nelson, MS, MPH         
Sponsors and Collaborators
DMG Dental Material Gesellschaft mbH
Investigators
Principal Investigator: Joel Berg, DDS, MS The Center for Pediatric Dentistry
  More Information

No publications provided

Responsible Party: DMG Dental Material Gesellschaft mbH
ClinicalTrials.gov Identifier: NCT01796106     History of Changes
Other Study ID Numbers: DETECT13
Study First Received: November 1, 2012
Last Updated: June 20, 2014
Health Authority: Germany: Ethics Commission
United States: Institutional Review Board

Keywords provided by DMG Dental Material Gesellschaft mbH:
caries infiltration
caries progression
Icon

Additional relevant MeSH terms:
Fluorides
Cariostatic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents

ClinicalTrials.gov processed this record on November 27, 2014