Clinical Trial Proximal Caries Infiltration and Detection

NCT01796106 | Terminated Results

• 1 other identifier: DETECT13
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the clinical efficacy of resin infiltration (Icon, DMG, Germany) compared to fluoride varnish (Duraphat Fluoride Varnish, Colgate, USA) in the management of proximal early caries lesions in primary molars over 24 months. In addition, this study will assess the use of a scanning fiber endoscope (SFE) laser optical device for the assessment of caries lesions and their progression in comparison to radiographic examination. A total of 50 participants (age 6-13 years) with at least 1 proximal early caries lesion will be enrolled. The participants will be followed up at 12 and 24 months. Lesion status will be monitored through radiographic and SFE laser optical device imaging.

Conditions

Caries,Dental

Keywords

Caries infiltration; Resin infiltration; Caries progression; Icon

Outcome Measures

Primary Outcomes (1)

• Number of Lesions That Changed in Size (E1->E2->D1->D2-> Filling)

  Change in categorical lesion depth (progression to next depth category lesion; E1-\>E2-\>D1-\>D2-\>filling) as measured by pairwise comparison of radiographs (baseline versus follow up time point). E1 (lesion within the outer half of enamel), E2 (inner half of enamel), D1 (outer third of dentin), D2 (middle third of dentin).

  24 months

Secondary Outcomes (2)

• Validation of SFE Imaging for Lesion Size Assessment: SFE Imaging vs. Radiographic Imaging

  0, 12 and 24 months

• Number of Lesions That Changed in Size (E1->E2->D1->D2-> Filling)

  12 months

Study Arms (2)

Resin infiltration

EXPERIMENTAL

Enrolled proximal early caries lesions will be treated using the resin infiltrant Icon (DMG, Germany).

Device: Resin infiltration

Fluoride varnish & Oral hygiene instruction

ACTIVE COMPARATOR

Oral hygiene instruction and topical fluoridation therapy (Duraphat Fluoride Varnish, Colgate, USA) will be provided.

Device: Fluoride varnish & Oral hygiene instruction

Interventions

Resin infiltration DEVICE

Up to two proximal early caries lesions (only if the second lesion is in a separate quadrant) per participant will be included. After radiographic and SFE imaging to assess lesion depth, the study lesions will be treated using the resin infiltrant Icon (DMG, Germany) according to manufactures´ instructions. Essentially, the treatment consists of the following parts: 1) isolating the tooth with a rubber dam and cleaning its surface; 2) removing/ conditioning the surface layer of the lesion (using Icon-Etch) to open the lesion body; 3) drying of the exposed porous enamel; 4) infiltrating the existing pore volume with the resin infiltrant (Icon Infiltrant); 5) light curing of the resin infiltrant; 6) repeating the infiltration step including light curing; followed by 7) finalizing using interproximal finishing/polishing strips.

Also known as: Icon (DMG, Germany), approximal resin infiltration kit

Resin infiltration

Fluoride varnish & Oral hygiene instruction DEVICE

Up to two proximal early caries lesions (only if the second lesion is in a separate quadrant) per participant will be included. After radiographic and SFE imaging to assess lesion depth oral hygiene instruction and topical fluoridation therapy will be provided. For topical fluoridation Duraphat Fluoride Varnish (Colgate, USA) will be used according to manufactures´ instructions.

Also known as: Duraphat Fluoride Varnish (Colgate, USA)

Fluoride varnish & Oral hygiene instruction

Eligibility Criteria

• Age: 6 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age 6-13 years
• Early caries lesions in primary molars (depth: E1 or E2)
• Good general health
• Available for 12 \& 24 months recalls
• Signed consent/assent/HIPAA
• Criteria used to assess teeth for acceptance into this study:
• Teeth fully erupted, in functional occlusion and
• Radiographic evidence of early caries in interproximal areas

You may not qualify if:

• Participation in other study
• History of adverse reaction on clinical material
• Sensitivity during screening test
• Poor access to teeth
• Patient refusing radiographic examination

Sponsors & Collaborators

• DMG Dental Material Gesellschaft mbH: lead

Study Sites (1)

The Center for Pediatric Dentistry

Seattle, Washington, 98115, United States

Location

Related Publications (1)

• Anusavice KJ. Present and future approaches for the control of caries. J Dent Educ. 2005 May;69(5):538-54.

  PMID: 15897335 BACKGROUND

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Results Point of Contact

• Title: Manager Clinical Research
• Organization: DMG Dental Material Gesellschaft mbH

clinicalresearch@mtcompanies.com

04084006

Study Officials

• Joel Berg, DDS, MS

  The Center for Pediatric Dentistry

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2012
• First Posted: February 21, 2013
• Study Start: March 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: July 19, 2023
• Results First Posted: July 19, 2023

Record last verified: 2023-06

Locations

US (1)