Resin Infiltration to Arrest Early Tooth Decay

NCT01584024 | Completed Results

• 2 other identifiers: N010508-S312-PAF02598
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether lesion infiltration is an effective management strategy to arrest early tooth decay.

Conditions

Dental Caries

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Number of Lesions With Progression as Measured by Pairwise (PW) Comparison (N=Lesions)

  Cumulative lesion progression as measured by PW comparison of radiographs (baseline versus 3 year)

  3 Years

Secondary Outcomes (1)

• Number of Lesions With Progression as Measured by Depth Category (N=Lesions)

  3 Years

Study Arms (2)

Resin infiltration

ACTIVE COMPARATOR

Resin infiltration of early caries lesion in addition to preventative measures (oral hygiene, diet counseling, repeated fluoride varnish application)

Device: Resin infiltration

Control

SHAM COMPARATOR

Sham treatment of early caries lesion in addition to preventative measures (oral hygiene, diet counseling, repeated fluoride varnish application)

Device: Sham treatment

Interventions

Resin infiltration DEVICE

Baseline treatment of one caries lesion with resin infiltration therapy, in addition to preventative measures and behavioral modification. ICON product: FDA-510(k): K100062

Also known as: ICON Infiltration kit (DMG, Germany) (ICON=product name)

Resin infiltration

Sham treatment DEVICE

Baseline treatment of one caries lesion with sham treatment, in addition to preventative measures and behavioral modification.

Control

Eligibility Criteria

• Age: 18 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• DMFT ≥ 3 (DMFT = index of decayed-missing-filled permanent teeth)
• Having at least two early caries lesions in approximal posterior tooth surfaces
• Lesions 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

Sponsors & Collaborators

• University of Michigan: lead
• DMG Dental Material Gesellschaft mbH: collaborator

Study Sites (1)

Saunders USADC

West Point, New York, 10996, United States

Location

Related Publications (1)

• Peters MC, Hopkins AR Jr, Zhu L, Yu Q. Efficacy of Proximal Resin Infiltration on Caries Inhibition: Results from a 3-Year Randomized Controlled Clinical Trial. J Dent Res. 2019 Dec;98(13):1497-1502. doi: 10.1177/0022034519876853. Epub 2019 Sep 16.

  PMID: 31526071 DERIVED

MeSH Terms

Conditions

Dental Caries; Tooth Diseases

Condition Hierarchy (Ancestors)

Tooth Demineralization; Stomatognathic Diseases

Results Point of Contact

• Title: Dr. Mathilde Peters (PI)
• Organization: University of Michigan

mcpete@umich.edu

734-925-2750

Study Officials

• Mathilde C Peters, DMD, PhD

  University of Michigan

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

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 Emerita

Study Record Dates

• First Submitted: April 20, 2012
• First Posted: April 24, 2012
• Study Start: March 1, 2013
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: February 12, 2019
• Results First Posted: February 12, 2019

Record last verified: 2019-01

Locations

US (1)