Evaluation of Optical Coherence Tomography in Dentistry
NCT ID: NCT03753256
Last Updated: 2018-11-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
20 participants
INTERVENTIONAL
2017-12-04
2027-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Optical Coherence Tomography (OCT) Based Intraoral Scanner
NCT07092592
Automated Quantification of Dental Plaque
NCT06789835
In Vivo Assessment of the Tooth-Resin Composite Interface Using Optical Coherence Tomography
NCT05145322
Trueness of Digital Occlusal Analysis
NCT06672627
3D Scanning and Transillumination vs Conventional Examination to Assess Caries Progression, Stability or Regression
NCT05409625
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SCREENING
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
Transbond XT
Application of
• Transbond XT (activator comparator) to labial surfaces of teeth of randomized quadrants.
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
Protecto®CaF2Nano
Application of
• Protecto®CaF2Nano (orthodontic surface sealant) to labial surfaces of teeth of randomized quadrants.
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
Pro Seal®
Application of
• Protecto®CaF2Nano (orthodontic surface sealant) to labial surfaces of teeth of randomized quadrants.
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
Opal®Seal
Application of
• Opal®Seal (orthodontic surface sealant) to labial surfaces of teeth of randomized quadrants.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Transbond XT
Application of
• Transbond XT (activator comparator) to labial surfaces of teeth of randomized quadrants.
Protecto®CaF2Nano
Application of
• Protecto®CaF2Nano (orthodontic surface sealant) to labial surfaces of teeth of randomized quadrants.
Pro Seal®
Application of
• Protecto®CaF2Nano (orthodontic surface sealant) to labial surfaces of teeth of randomized quadrants.
Opal®Seal
Application of
• Opal®Seal (orthodontic surface sealant) to labial surfaces of teeth of randomized quadrants.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Informed consent from all patients and their parents or legal guardians after explaining of the study
Exclusion Criteria
6 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Heidelberg Engineering GmbH
INDUSTRY
University of Heidelberg Medical Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Sinan Sen
Senior Teaching and Research Assistant
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Sinan Sen, Dr.
Role: STUDY_DIRECTOR
Department of Orthodontics and Dentofacial Orthopaedics, University of Heidelberg
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Department of Orthodontics and Dentofacial Orthopaedics, University of Heidelberg
Heidelberg, , Germany
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Alsayed EZ, Hariri I, Sadr A, Nakashima S, Bakhsh TA, Shimada Y, Sumi Y, Tagami J. Optical coherence tomography for evaluation of enamel and protective coatings. Dent Mater J. 2015;34(1):98-107. doi: 10.4012/dmj.2014-215.
Levin SM. Portasystemic shunts for portal hypertension: early and late results in a personal series of 140 operations. Vasc Surg. 1974 Jan-Feb;8(1):20-5. No abstract available.
Ryf S, Flury S, Palaniappan S, Lussi A, van Meerbeek B, Zimmerli B. Enamel loss and adhesive remnants following bracket removal and various clean-up procedures in vitro. Eur J Orthod. 2012 Feb;34(1):25-32. doi: 10.1093/ejo/cjq128. Epub 2011 Jan 12.
Lee SH, Lee JJ, Chung HJ, Park JT, Kim HJ. Dental optical coherence tomography: new potential diagnostic system for cracked-tooth syndrome. Surg Radiol Anat. 2016 Jan;38(1):49-54. doi: 10.1007/s00276-015-1514-8. Epub 2015 Jul 14.
Leao Filho JC, Braz AK, de Araujo RE, Tanaka OM, Pithon MM. Enamel Quality after Debonding: Evaluation by Optical Coherence Tomography. Braz Dent J. 2015 Jul-Aug;26(4):384-9. doi: 10.1590/0103-6440201300406.
Zingler S, Sommer A, Sen S, Saure D, Langer J, Guillon O, Lux CJ. Efficiency of powered systems for interproximal enamel reduction (IER) and enamel roughness before and after polishing-an in vitro study. Clin Oral Investig. 2016 Jun;20(5):933-42. doi: 10.1007/s00784-015-1585-2. Epub 2015 Sep 30.
Sen S, Erber R, Orhan G, Zingler S, Lux CJ. OCT evaluation of orthodontic surface sealants: a 12-month follow-up randomized clinical trial. Clin Oral Investig. 2021 Mar;25(3):1547-1558. doi: 10.1007/s00784-020-03462-7. Epub 2020 Aug 13.
Deurer N, Erber R, Orhan G, Zingler S, Lux CJ, Sen S. Abrasion of Pro Seal(R) and Opal(R) Seal by professional tooth cleaning protocols: results from an in vitro study and a randomized controlled trial. Eur J Orthod. 2020 Dec 2;42(6):596-604. doi: 10.1093/ejo/cjz096.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
S-370/2015
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.