Evaluation of Optical Coherence Tomography in Dentistry
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6+
SponsorUniversity of Heidelberg Medical Center
About this trial
Optical coherence tomography (OCT) is a medical diagnostic tool, providing non-invasive, non-radiative and high resolution imaging. OCT has been established since many years in ophthalmology. In dentistry the diagnostic potential of OCT is currently increasingly being noticed. This clinical study includes two individual trials: (i) Longitudinal assessment of surface sealant thickness using optical coherence tomography and (ii) comparison of crevicular fluid levels of inflammatory cytokines after the application of surface sealants.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Orthodontic treatment need
Informed consent from all patients and their parents or legal guardians after explaining of the study
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Transbond XT
DeviceApplication of • Transbond XT (activator comparator) to labial surfaces of teeth of randomized quadrants.
Protecto®CaF2Nano
DeviceApplication of • Protecto®CaF2Nano (orthodontic surface sealant) to labial surfaces of teeth of randomized quadrants.
Pro Seal®
DeviceApplication of • Protecto®CaF2Nano (orthodontic surface sealant) to labial surfaces of teeth of randomized quadrants.
Opal®Seal
DeviceApplication of • Opal®Seal (orthodontic surface sealant) to labial surfaces of teeth of randomized quadrants.
Treatment groups
20 Participants
are divided into 4 treatment groupsGroup A: Transbond XTActive comparator 1 intervention
Group B: Protecto®CaF2NanoExperimental treatment 1 intervention
Group C: Pro Seal®Experimental treatment 1 intervention
Group D: Opal® SealExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Abrasion behaviour of orthodontic surface sealants
Longitudinal assesment of surface sealant thickness using optical coherence tomography
Time frame
The thickness changes of the orthodontic surface sealants and the development of enamel demineralization will be monitored at the day of the application and five additional time points (t1= 1 month, t2= 3 months, t3= 6 months, t4=9 months, t5= 12 months)Secondary outcomes
1
Adverse effects of orthodontic surface sealants
To evaluate possible adverse effects of orthodontic surface sealants in vivo gingival crevicular fluid will be sampled in the respective quadrants at the day of bracket bonding prior (t0) and at three additional time points (t1= 30 min, t2= 60 min, t3= 90 min) after the application of surface sealants or the bonding primer. Existing data on possible adverse effects of resin monomers from restorative composites or surface sealants were obtained using 3D tissue models; therefore, in the present study the investigators will attempt to evaluate possible adverse effects of commonly used smooth surface sealants on gingival tissues by analysing inflammatory cytokines in crevicular fluid of the participants after the application of surface sealants.To this end, the levels of the inflammatory cytokines (IL-8 (Interleukin 8), and IL-10 (Interleukin 10) in GCF will be assessed using multiplex analysis.
Time frame
To assess cytokine levels GCF will be sampled at the day of bracket bonding prior (t0) and at three additional time points (t1= 30 min, t2= 60 min, t3= 90 min) after the application of surface sealants or the bonding primer, respectively.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Heidelberg Medical Center
Lead sponsor
Heidelberg Engineering GmbH
Collaborator
Source ClinicalTrials.gov