Radiographic Progression of Infiltrated Caries Lesions In-vivo (ICON)

This study is investigating the efficacy of caries lesion infiltration therapy as compared to the current preventative approach for early caries lesions.

Study Overview

• Status: Completed
• Conditions: Dental Caries
• Intervention / Treatment: Behavioral: Caries management; Device: Resin infiltration

Detailed Description

A 3-year longitudinal, prospective, randomized control clinical trial (RCT) is designed incorporating a split-mouth intra-oral design. Young volunteers (14-35 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 infiltrating the lesions. The infiltration protocol included application of on-market materials and applicators, and was performed in one session.

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Toledo, Ohio, United States, 43614
      • University of Toledo Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 35 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 14-35 year old subjects
• decayed-missing-filled permanent teeth (DMFT) ≥ 3
• having at least two early caries lesions in approximal posterior tooth surfaces
• lesion visible on radiograph

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Preventative measures; Caries management by preventative measures of oral hygiene instruction, diet counseling and fluoride supplementation	Behavioral: Caries management; Split-mouth design (at least two lesions per patient). Baseline preventative caries management: dietary and behavioral modification, and over-the-counter fluoride supplements; Other Names: Home use of over-the-counter oral health products
Active Comparator: Lesion infiltration; Resin infiltration of caries lesion in addition to caries management by preventative measures of oral hygiene instruction, diet counseling and fluoride supplementation	Behavioral: Caries management; Split-mouth design (at least two lesions per patient). Baseline preventative caries management: dietary and behavioral modification, and over-the-counter fluoride supplements; Other Names: Home use of over-the-counter oral health products; Device: Resin infiltration; Split-mouth design (at least two lesions per patient): Treatment of one caries lesion with resin infiltration therapy; Other Names: ICON (DMG, Germany)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Lesions Showing Radiographic Progression as Measured by Lesion Size (Continuous)	Pairwise radiographic assessment of lesion progression: combined visual assessment (PWA) and digital subtraction radiography (DSR).	Baseline through 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Lesions Showing Radiographic Progression as Measured by Lesion Depth Categories	Radiographic assessment of lesion depth category (R1-R5) by single radiograph assessment (SRA).	Baseline through 3 years
Lesion Survival After 3 Years	Discrete time survival analysis of time to first lesion progression.	3 years

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: DMG Dental Material Gesellschaft mbH

Publications and helpful links

General Publications

• Peters MC, Tuzzio F, Nedley M, Davis W, Bayne SC. Resin Infiltration Effects In A Caries-Active Environment. J Dent Res 92(Spec Iss A):377, 2013.
• Peters MC, Tuzzio F, Nedley M, Davis W, Bayne SC. Resin Infiltration Effects In A Caries-Active Environment - 2YR Results. J Dent Res 93(Spec Iss A):161, 2014.
• Peters MC, Bula A, Nedley M, Davis W, Bayne SC. Efficacy of Resin Infiltration in High Caries-Active Environment -- 3YR Results. J Dent Res 93(Spec Iss B): 1017, 2014.

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: December 9, 2011
• First Submitted That Met QC Criteria: December 20, 2011
• First Posted (Estimate): December 21, 2011

Study Record Updates

• Last Update Posted (Actual): August 8, 2017
• Last Update Submitted That Met QC Criteria: July 9, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Dental caries; Preventive therapy; Proximal surfaces; Posterior teeth; Carious lesions; Tooth diseases
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries
• Other Study ID Numbers: PG#N010508; 10-PAF03721 (Other Identifier: U-Michigan)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO