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NCT Number: NCT03753256

Evaluation of Optical Coherence Tomography in Dentistry

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.

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Key information

Conditions

Dental Caries Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

6 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Orthodontics and Dentofacial Orthopaedics, University of Heidelberg

Heidelberg, 69120, Germany

Location status: Recruiting

Location contact

Sebastian Zingler, Dr.

CONTACT

[email protected]

004956 ext. 36565

Sinan Sen, Dr.

CONTACT

[email protected]

0049622156 ext. 6583

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transbond XT

Device

Application of

  • Transbond XT (activator comparator) to labial surfaces of teeth of randomized quadrants.

Protecto®CaF2Nano

Device

Application of

  • Protecto®CaF2Nano (orthodontic surface sealant) to labial surfaces of teeth of randomized quadrants.

Pro Seal®

Device

Application of

  • Protecto®CaF2Nano (orthodontic surface sealant) to labial surfaces of teeth of randomized quadrants.

Opal®Seal

Device

Application of

  • Opal®Seal (orthodontic surface sealant) to labial surfaces of teeth of randomized quadrants.

Primary outcomes

  1. Abrasion behaviour of orthodontic surface sealants

    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)

    Longitudinal assesment of surface sealant thickness using optical coherence tomography

Secondary outcomes

  1. Adverse effects of orthodontic surface sealants

    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.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sinan Sen, Dr.

CONTACT

[email protected]

0049622156 ext. 6583

Sponsors and collaborators

Lead sponsor

University of Heidelberg Medical Center

Other

Collaborators

  • Heidelberg Engineering GmbH

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2027
First posted
Nov 26, 2018
Registry last updated
Nov 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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