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Evaluation of Optical Coherence Tomography in Dentistry

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ClinicalTrials.gov Identifier: NCT03753256
Recruitment Status : Recruiting
First Posted : November 26, 2018
Last Update Posted : November 28, 2018
Sponsor:
Collaborator:
Heidelberg Engineering GmbH
Information provided by (Responsible Party):
Sinan Sen, University of Heidelberg Medical Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Dental Caries Tooth Demineralization Device: Transbond XT Device: Protecto®CaF2Nano Device: Pro Seal® Device: Opal®Seal Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Screening
Official Title: Evaluation of Optical Coherence Tomography in Dentistry
Actual Study Start Date : December 4, 2017
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : December 2027
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 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
 Device: Transbond XT

Application of

• Transbond XT (activator comparator) to labial surfaces of teeth of randomized quadrants.
Experimental: 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
 Device: Protecto®CaF2Nano

Application of

• Protecto®CaF2Nano (orthodontic surface sealant) to labial surfaces of teeth of randomized quadrants.
Experimental: 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
 Device: Pro Seal®

Application of

• Protecto®CaF2Nano (orthodontic surface sealant) to labial surfaces of teeth of randomized quadrants.
Experimental: 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
 Device: Opal®Seal

Application of

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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   6 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03753256


Contacts
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Contact: Sinan Sen, Dr. 0049622156 ext 6583 sinan.sen@med.uni-heidelberg.de

Locations
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Germany
Department of Orthodontics and Dentofacial Orthopaedics, University of Heidelberg Recruiting
Heidelberg, Germany, 69120
Contact: Sinan Sen, Dr.    0049622156 ext 6583    sinan.sen@med.uni-heidelberg.de   
Contact: Sebastian Zingler, Dr.    004956 ext 36565    sebastian.zingler@med.uni-heidelberg.de   
Sponsors and Collaborators
University of Heidelberg Medical Center
Heidelberg Engineering GmbH
Investigators
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Study Director: Sinan Sen, Dr. Department of Orthodontics and Dentofacial Orthopaedics, University of Heidelberg
More Information
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Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Sinan Sen, Senior Teaching and Research Assistant, University of Heidelberg Medical Center
ClinicalTrials.gov Identifier: NCT03753256    
Other Study ID Numbers: S-370/2015
First Posted: November 26, 2018    Key Record Dates
Last Update Posted: November 28, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases