Evaluation of Optical Coherence Tomography in Dentistry

University of Heidelberg Medical Center

Status: Enrolling

Conditions: Tooth Demineralization; Dental Caries

Treatments: Device: Pro Seal®; Device: Transbond XT; Device: Opal®Seal; Device: Protecto®CaF2Nano

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03753256

S-370/2015

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 6+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Orthodontic treatment need
• Informed consent from all patients and their parents or legal guardians after explaining of the study

Exclusion criteria

• withdrawn consent

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 4 patient groups

Transbond XT

Active Comparator group

Description:

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

Treatment:

Device: Transbond XT

Protecto®CaF2Nano

Experimental group

Description:

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

Treatment:

Device: Protecto®CaF2Nano

Pro Seal®

Experimental group

Description:

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

Treatment:

Device: Pro Seal®

Opal® Seal

Experimental group

Description:

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

Treatment:

Device: Opal®Seal