NCT01496456

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

December 9, 2011

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 21, 2011

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
2 years until next milestone

Results Posted

Study results publicly available

July 14, 2016

Completed
Last Updated

August 8, 2017

Status Verified

July 1, 2017

Enrollment Period

4.2 years

First QC Date

December 9, 2011

Results QC Date

February 17, 2016

Last Update Submit

July 9, 2017

Conditions

Dental Caries

Keywords

Dental cariesProximal surfacesPosterior teethCarious lesionsTooth diseasesPreventive therapy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

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

    Baseline through 3 years

  • Lesion Survival After 3 Years

    3 years

Study Arms (2)

Preventative measures

PLACEBO COMPARATOR

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

Behavioral: Caries management

Lesion infiltration

ACTIVE COMPARATOR

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

Device: Resin infiltrationBehavioral: Caries management

Interventions

Resin infiltrationDEVICE

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

Also known as: ICON (DMG, Germany)
Lesion infiltration
Caries managementBEHAVIORAL

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

Also known as: Home use of over-the-counter oral health products
Lesion infiltrationPreventative measures

Eligibility Criteria

Age14 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Toledo Medical Center

Toledo, Ohio, 43614, United States

Location

Related Publications (3)

  • 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.

    RESULT

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

    PMID: 25080756RESULT

  • 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.

    RESULT

MeSH Terms

Conditions

Dental CariesTooth Diseases

Condition Hierarchy (Ancestors)

Tooth DemineralizationStomatognathic Diseases

Limitations and Caveats

Small number of subjects analyzed.

Results Point of Contact

Title
Dr. Mathilde C Peters
Organization
UMichigan
mcpete@umich.edu

Study Officials

  • Mathilde C Peters, DMD, PhD

    University of Michigan

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 9, 2011

First Posted

December 21, 2011

Study Start

May 1, 2010

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

August 8, 2017

Results First Posted

July 14, 2016

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)