Evaluation of Optical Coherence Tomography in Dentistry
- Conditions
- Tooth DemineralizationDental Caries
- Interventions
- Device: Transbond XTDevice: Pro Seal®Device: Protecto®CaF2NanoDevice: Opal®Seal
- Registration Number
- NCT03753256
- Lead Sponsor
- University of Heidelberg Medical Center
- Brief Summary
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.
- Detailed Description
Trial 1: Evaluation of the abrasion behavior of the orthodontic surface sealants Pro Seal®, Opal®Seal, and Protecto®CaF2Nano. The quadrants of 20 participants will be randomly assigned to four study groups. Using a split mouth design three commonly used orthodontic surface sealants (Pro Seal®, Opal®Seal, and Protecto®CaF2Nano) and a bonding primer (Transbond XT) which is used as a control will be applied to the labial surfaces of the teeth of the respective quadrants. 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) using OCT.
Trial 2: Evaluation of Adverse effects of orthodontic surface sealants. 15 quadrants of the trial group described above (Trial1) will be randomly selected and gingival crevicular fluid (GCF) 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, respectively. Analysis will be performed using magnetic Luminex screening assays for IL-8 (Interleukin 8), and IL-10 (Interleukin 10) and examined for inflammatory cytokines after the application of surface sealants.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 20
- Orthodontic treatment need
- Informed consent from all patients and their parents or legal guardians after explaining of the study
• withdrawn consent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Transbond XT Transbond XT Application of different orthodontic surface sealants to participants: Randomly assigned quadrants in this arm will receive a bonding primer (Transbond XT) The investigators will evaluate in this arm 1. the development of demineralization 2. its adverse effects after application Pro Seal® Pro Seal® Application of different orthodontic surface sealants to participants: Randomly assigned quadrants in this arm will receive an orthodontic surface sealant (Pro Seal®). The investigators will evaluate in this arm 1. its abrasion behavior and the development of demineralization 2. its adverse effects after the application Protecto®CaF2Nano Protecto®CaF2Nano Application of different orthodontic surface sealants to participants: Randomly assigned quadrants in this arm will receive an orthodontic surface sealant (Protecto®CaF2Nano). The investigators will evaluate in this arm 1. its abrasion behavior and the development of demineralization 2. its adverse effects after the application Opal® Seal Opal®Seal Application of different orthodontic surface sealants to participants: Randomly assigned quadrants in this arm will receive an orthodontic surface sealant (Opal®Seal). The investigators will evaluate in this arm 1. its abrasion behavior and the development of demineralization 2. its adverse effects after the application
- Primary Outcome Measures
Name Time Method Abrasion behaviour of orthodontic surface sealants 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) Longitudinal assesment of surface sealant thickness using optical coherence tomography
- Secondary Outcome Measures
Name Time Method Adverse effects of orthodontic surface sealants 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. 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.
Trial Locations
- Locations (1)
Department of Orthodontics and Dentofacial Orthopaedics, University of Heidelberg
🇩🇪Heidelberg, Germany