Radiographic Progression of Infiltrated Caries Lesions In-vivo

Dental Caries Clinical Trial

— ICON  

Official title:

Radiographic Progression of Infiltrated Caries Lesions In-vivo

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01496456
• Other study ID #: PG#N010508
• Secondary ID: 10-PAF03721
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: December 9, 2011
• Last updated: July 12, 2016
• Start date: May 2010
• Est. completion date: July 2014

Study information

• Verified date: July 2016
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years to 35 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dental Caries

Intervention

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

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

Locations

Country	Name	City	State
United States	University of Toledo Medical Center	Toledo	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	DMG Dental Material Gesellschaft mbH

Country where clinical trial is conducted

United States, 

References & Publications (3)

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.

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, 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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Lesion Survival After 3 Years	Discrete time survival analysis of time to first lesion progression.	3 years	No