NCT01796106 is a NA clinical trial of Resin infiltration in Caries,Dental, sponsored by DMG Dental Material Gesellschaft mbH.

Who is sponsoring NCT01796106?

NCT01796106 is sponsored by DMG Dental Material Gesellschaft mbH.

What drugs are being tested in NCT01796106?

Interventions in NCT01796106: Resin infiltration, Fluoride varnish & Oral hygiene instruction.

What condition does NCT01796106 study?

NCT01796106 studies Caries,Dental.

Is NCT01796106 still recruiting?

NCT01796106 is currently terminated. Last updated 28 June 2023.

Are results published for NCT01796106?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2023-06-28 · How we verify

NCT01796106

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Clinical Efficacy of Caries Infiltration (Icon) - A Randomized, Blinded and Controlled Pilot Study of Early Caries Progression Detection

Terminated NA Results posted Last updated 28 June 2023

What this trial tests

NA trial testing Resin infiltration in Caries,Dental in 12 participants. Terminated before completion.

Timeline

1 March 2015

Primary endpoint
1 March 2016

1 March 2016

Quick facts

Lead sponsor	DMG Dental Material Gesellschaft mbH
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	12
Start date	1 March 2015
Primary completion	1 March 2016
Estimated completion	1 March 2016
Sites	1 location across United States

Drugs / interventions tested

Resin infiltration — full drug profile →
Fluoride varnish & Oral hygiene instruction

Conditions studied

Caries,Dental — all drugs for Caries,Dental →

Sponsor

DMG Dental Material Gesellschaft mbH

Who can join

Adults 6 to 13, any sex, with Caries,Dental. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Number of Lesions That Changed in Size (E1->E2->D1->D2-> Filling)
Time frame: 24 months
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).

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other trials of Resin infiltration

Trials testing the same drug.

NCT07118111 — Effect of Resin Infiltration on Hypersensitivity and Satisfaction in Children With Enamel Defects · NA · completed
NCT06696105 — Assessing the Effects of Resin Infiltration and Resin Modified Glass Ionomer on the Color Changes of White Spot Lesions · Phase 4 · active not recruiting
NCT07494682 — Comparison of Two Minimally Invasive Approaches for Masking Molar-Incisor Hypomineralization Opacities · NA · completed
NCT06135272 — Evaluation of Three Different Minimally Invasive Techniques for Management of Enamel Opacities in Patients With Molar In · Phase 4 · unknown
NCT05733676 — Comparison of MI Paste Plus and Resin Infiltration in White Spot Lesions Following Orthodontic Treatment · NA · recruiting

Other recruiting trials for Caries,Dental

Currently open trials in the same condition.

NCT07323433 — Efficacy of a Chitosan Dressing in Pulpotomy of Immature Permanent Teeth · NA · recruiting
NCT06690229 — Evaluation of Different Cementation Materials Used in Prefabricated Pediatric Zirconia Crowns · NA · active not recruiting
NCT06453005 — Comparative Evaluation of SMART Hall Technique Vs. Conventional SS Crown in Primary Molars: a Randomized Clinical Trial · NA · recruiting
NCT05860712 — Evaluation of Antimicrobial, Post Operative Pain of Cinnamon Extract Versus Sodium Hypochlorite Irrigant Following Pulpe · NA · recruiting
NCT05969756 — Early Treatments for Preventing Occlusal Caries Lesions · NA · active not recruiting

Other DMG Dental Material Gesellschaft mbH trials

Trials by the same sponsor.

NCT03429829 — Fluoride Varnish Community Trial · NA · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01796106 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by DMG Dental Material Gesellschaft mbH
Last refreshed: 28 June 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01796106.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing