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
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Condition or disease | Intervention/treatment | Phase |
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Dental Caries Tooth Demineralization | Device: Transbond XT Device: Protecto®CaF2Nano Device: Pro Seal® Device: Opal®Seal | Not Applicable |
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 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 |
Arm | Intervention/treatment |
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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
|
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
|
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
|
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
|
Device: Opal®Seal
Application of • Opal®Seal (orthodontic surface sealant) to labial surfaces of teeth of randomized quadrants. |
- 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
- 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.

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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 |
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

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
Contact: Sinan Sen, Dr. | 0049622156 ext 6583 | sinan.sen@med.uni-heidelberg.de |
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 |
Study Director: | Sinan Sen, Dr. | Department of Orthodontics and Dentofacial Orthopaedics, University of Heidelberg |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Dental Caries Tooth Demineralization Tooth Diseases Stomatognathic Diseases |