Evaluation of Optical Coherence Tomography in Dentistry

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Transbond XT
  Application of • Transbond XT (activator comparator) to labial surfaces of teeth of randomized quadrants.
• Устройство Protecto®CaF2Nano
  Application of • Protecto®CaF2Nano (orthodontic surface sealant) to labial surfaces of teeth of randomized quadrants.
• Устройство Pro Seal®
  Application of • Protecto®CaF2Nano (orthodontic surface sealant) to labial surfaces of teeth of randomized quadrants.
• Устройство Opal®Seal
  Application of • Opal®Seal (orthodontic surface sealant) to labial surfaces of teeth of randomized quadrants.

Первичные конечные точки

• Abrasion behaviour of orthodontic surface sealants [Срок оценки: 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)]

Вторичные конечные точки (1)

• Adverse effects of orthodontic surface sealants [Срок оценки: 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.]

Критерии участия

Критерии включения

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

Критерии исключения

• withdrawn consent

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Скрининг

Центры проведения

Германия · 1 центр

• Department of Orthodontics and Dentofacial Orthopaedics, University of Heidelberg — Heidelberg

Публикации

• 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. PMID 25748465
• 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. PMID 4544493
• 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. PMID 21228118
• 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. PMID 26168856
• 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. PMID 26312977
• 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. PMID 26419674
• 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. PMID 32789656
• 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. PMID 31765473

Идентификаторы

NCT: NCT03753256 · S-370/2015

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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