Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

Introduction: Dental caries remains one of the most prevalent diseases worldwide. It is a dynamic process that causes destruction of tooth structure by dissolving the enamel. While it is possible to restore the structure and function of the tooth by placing a filling, it is preferable to slow down or reverse the caries process at an early state. Proximal surfaces are hereby particularly susceptible to caries as the contact area between teeth is difficult to access. While non-invasive techniques such as remineralization (using topical fluoride) or biofilm control are options to manage early caries lesions, their effectiveness may be compromised due to poor patient compliance. Alternatives are micro-invasive strategies such as resin infiltration, whereby a highly viscous resin is infiltrated into the porous enamel of caries lesions to erect an internal barrier that blocks acid diffusion, thereby inhibiting caries lesion progression. Another important aspect in caries management is diagnostic, with visual-tactile examination and radiographs being standard of care. However, visual-tactile techniques are known to be unreliable due to subjectivity and fail to differentiate between varies stages of caries progression. Caries diagnostic is thus assisted by radiographic imaging, which however, also has a limited sensitivity and requires the use of x-rays. While alternatives for caries imaging have been developed (e.g. quantitative laser or light fluorescence (QLF) or electrical conductance measurements (ECM)) no gold standard could be established so far highlighting the need for new save and sensitive imaging techniques. Objective: To assess 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 over 24 months. In addition, the use of a SFE laser optical device for the assessment of caries lesions and their progression will be assessed in comparison to radiographic examination. Materials and Methods: 50 volunteers (age 6-13 years) with at least 1 proximal early caries lesion in primary molars will be enrolled and randomly assigned to the resin infiltration and control groups. In the resin infiltration group early caries lesions will be treated using Icon (DMG), whereas the lesions in the control group will be managed using Oral Hygiene Instructions (OHI) and topical fluoridation (Duraphat Fluoride Varnish, Colgate). Lesion depth will be assessed through radiographic evaluation as well as through a novel optical device based on scanning fiber endoscope (SFE) technology for early caries detection through laser light imaging. SFE laser optical device prototypes developed by the University of Washington's Human Photonics Lab (HPL) will be utilized. Such a device is already in human use for applications such as imaging and cancer screening. Clinical Significance: Resin infiltration of early caries lesions may be an effective therapeutic strategy in paediatric dentistry to reduce caries progression. Additionally, the SFE optical device may be suitable technology to visualize early caries lesions and their progression, which would offer a safe alternative to radiography for assessing and monitoring dental caries. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01796106
Study type Interventional
Source DMG Dental Material Gesellschaft mbH
Contact
Status Terminated
Phase N/A
Start date March 2015
Completion date March 2016

See also
  Status Clinical Trial Phase
Not yet recruiting NCT05792215 - KAP of Dental Practitioners Regarding CRA
Not yet recruiting NCT05792800 - Dental Practitioners KAP Regarding Caries Preventive Measures in Cairo and Riyadah
Withdrawn NCT04104789 - Kovanaze Vs. Articaine in Achieving Pulpal Anesthesia of Maxillary Teeth - General Phase 2
Active, not recruiting NCT06211582 - Clinical Performances of 3-different Tooth-colored Restorative Materials in Class-II Cavities N/A
Active, not recruiting NCT04342858 - Prospective Randomized Controlled Trial for Prevention of Demineralization During Fixed Orthodontic Treatment Phase 2
Recruiting NCT05362461 - Diagnostic Ability of Near Infrared Transillumination Detecting Interproximal Caries as Compared to Conventional Bitewing Radiographs
Not yet recruiting NCT04422860 - Remineralization Efficacy of Gum Arabic Varnish. Phase 2/Phase 3
Not yet recruiting NCT06063239 - Probiotics in Special Needs Patients at High Risk for Tooth Decay: a Randomized Controlled Trial. N/A
Completed NCT04286256 - Using Motivational Interviewing To Reduce Parental Risk-Related Behaviors For Early Childhood Caries N/A
Completed NCT06182267 - Maximal Use Study to Determine the Pharmacokinetics of L-arginine After Exaggerated Oral Use of COL101 Phase 1
Not yet recruiting NCT03671200 - Correlation Between Caries Experience in Primary Molars and First Permanent Molars
Not yet recruiting NCT06365281 - Caries Prevalence, Experience and Risk Related Factors Among Early Middle-aged Patients Attending Cairo University
Completed NCT06242184 - Post-operative Sensitivity in Resin Composites N/A
Completed NCT04003493 - LifE Style, Nutrition and Oral Health in Care Givers (LENTO) N/A
Enrolling by invitation NCT04251858 - Evaluation of Oral Condition and the Effect of Dental Treatment on Physical Parameters of Athletes N/A
Not yet recruiting NCT05943782 - Evaluation of CAD/CAM Onlays Fabricated by Subtractive Versus Additive Digital Manufacturing Techniques. N/A
Recruiting NCT06114030 - Clinical and Radiographical Evaluation of CAD-CAM Crowns With and Without Deep Margin Elevation N/A
Recruiting NCT05756413 - Birth to Three - Cavity Free N/A
Completed NCT05231330 - Clinical Evaluation of Silver Nanoparticles in Comparison to Silver Diamine Fluoride in Management of Deep Carious Lesions N/A
Not yet recruiting NCT04303767 - The Effect of Casein Phosphopeptide Amorphous Calcium Phosphate on Affected Dentine Phase 2