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

Primary Purpose

Dental Caries

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Resin infiltration

Caries management

About this trial

This is an interventional treatment trial for Dental Caries focused on measuring Dental caries, Proximal surfaces, Posterior teeth, Carious lesions, Tooth diseases, Preventive therapy

Eligibility Criteria

14 Years - 35 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Toledo Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Preventative measures

Lesion infiltration

Arm Description

Caries management by preventative measures of oral hygiene instruction, diet counseling and fluoride supplementation

Resin infiltration of caries lesion in addition to caries management by preventative measures of oral hygiene instruction, diet counseling and fluoride supplementation

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).

Lesion Survival After 3 Years

Discrete time survival analysis of time to first lesion progression.

Full Information

NCT ID

NCT01496456

First Posted

December 9, 2011

Last Updated

July 9, 2017

Sponsor

University of Michigan

Collaborators

DMG Dental Material Gesellschaft mbH

1. Study Identification

Unique Protocol Identification Number

NCT01496456

Brief Title

Radiographic Progression of Infiltrated Caries Lesions In-vivo

Acronym

ICON

Official Title

Radiographic Progression of Infiltrated Caries Lesions In-vivo

Study Type

Interventional

2. Study Status

Record Verification Date

July 2017

Overall Recruitment Status

Completed

Study Start Date

May 2010 (undefined)

Primary Completion Date

July 2014 (Actual)

Study Completion Date

July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Michigan

Collaborators

DMG Dental Material Gesellschaft mbH

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dental Caries

Keywords

Dental caries, Proximal surfaces, Posterior teeth, Carious lesions, Tooth diseases, Preventive therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

17 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Preventative measures

Arm Type

Placebo Comparator

Arm Description

Caries management by preventative measures of oral hygiene instruction, diet counseling and fluoride supplementation

Arm Title

Lesion infiltration

Arm Type

Active Comparator

Arm Description

Resin infiltration of caries lesion in addition to caries management by preventative measures of oral hygiene instruction, diet counseling and fluoride supplementation

Intervention Type

Device

Intervention Name(s)

Resin infiltration

Other Intervention Name(s)

ICON (DMG, Germany)

Intervention Description

Split-mouth design (at least two lesions per patient): Treatment of one caries lesion with resin infiltration therapy

Intervention Type

Behavioral

Intervention Name(s)

Caries management

Other Intervention Name(s)

Home use of over-the-counter oral health products

Intervention Description

Split-mouth design (at least two lesions per patient). Baseline preventative caries management: dietary and behavioral modification, and over-the-counter fluoride supplements

Primary Outcome Measure Information:

Title

Number of Lesions Showing Radiographic Progression as Measured by Lesion Size (Continuous)

Description

Pairwise radiographic assessment of lesion progression: combined visual assessment (PWA) and digital subtraction radiography (DSR).

Time Frame

Baseline through 3 years

Secondary Outcome Measure Information:

Title

Number of Lesions Showing Radiographic Progression as Measured by Lesion Depth Categories

Description

Radiographic assessment of lesion depth category (R1-R5) by single radiograph assessment (SRA).

Time Frame

Baseline through 3 years

Title

Lesion Survival After 3 Years

Description

Discrete time survival analysis of time to first lesion progression.

Time Frame

3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

14 Years

Maximum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mathilde C Peters, DMD, PhD

Organizational Affiliation

University of Michigan

Official's Role

Study Chair

Facility Information:

Facility Name

University of Toledo Medical Center

City

Toledo

State/Province

Ohio

ZIP/Postal Code

43614

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

Citation

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.

Results Reference

result

PubMed Identifier

25080756

Citation

Resin infiltration effects in a caries-active environment. J Calif Dent Assoc. 2014 Jun;42(6):372. No abstract available.

Results Reference

result

Citation

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.

Results Reference

result

Learn more about this trial

Radiographic Progression of Infiltrated Caries Lesions In-vivo

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