Clinical Trial Proximal Caries Infiltration and Detection
|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|
- 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.
- 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.
|Study Start Date:||March 2015|
|Estimated Study Completion Date:||December 2017|
|Estimated Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
The study clinician will provide Icon treatment to all study participants randomized to study arm 1 after the radiograph and visual exam.
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01796106
|Contact: Joel Berg, DDS, MS||(206) firstname.lastname@example.org|
|Contact: Amy Kim, DDS||(206) 543-0407||Akim3@uw.edu|
|United States, Washington|
|The Center for Pediatric Dentistry||Recruiting|
|Seattle, Washington, United States, 98115|
|Contact: Joel Berg, DDS, MS 206-543-6695 email@example.com|
|Principal Investigator: Joel Berg, DDS,MS|
|Sub-Investigator: Amy Kim, DDS|
|Sub-Investigator: Travis Nelson, MS, MPH|
|Principal Investigator:||Joel Berg, DDS, MS||The Center for Pediatric Dentistry|