TerminatedNot Applicable

Clinical Trial Proximal Caries Infiltration and Detection

Stopped: Recruitment slower than expected.

United States12 participantsStarted 2015-03

Plain-language 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.

Who can participate

Age range6 Years – 13 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * Participation in other study * History of adverse reaction on clinical material * Sensitivity during screening test * Poor access to teeth * Patient refusing radiographic examination

What they're measuring

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

Timeframe: 24 months

Trial details

NCT IDNCT01796106

SponsorDMG Dental Material Gesellschaft mbH

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-03

Results submitted2023-06-05