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Evaluation of Optical Coherence Tomography in Dentistry

Primary Purpose

Dental Caries, Tooth Demineralization

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Transbond XT
Protecto®CaF2Nano
Pro Seal®
Opal®Seal
Sponsored by
University of Heidelberg Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Dental Caries

Eligibility Criteria

6 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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• withdrawn consent

Sites / Locations

  • Department of Orthodontics and Dentofacial Orthopaedics, University of HeidelbergRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Arm Label

Transbond XT

Protecto®CaF2Nano

Pro Seal®

Opal® Seal

Arm Description

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 the development of demineralization its adverse effects after application

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 its abrasion behavior and the development of demineralization its adverse effects after the application

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 its abrasion behavior and the development of demineralization its adverse effects after the application

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 its abrasion behavior and the development of demineralization its adverse effects after the application

Outcomes

Primary Outcome Measures

Abrasion behaviour of orthodontic surface sealants
Longitudinal assesment of surface sealant thickness using optical coherence tomography

Secondary Outcome Measures

Adverse effects of orthodontic surface sealants
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.

Full Information

First Posted
April 20, 2016
Last Updated
November 26, 2018
Sponsor
University of Heidelberg Medical Center
Collaborators
Heidelberg Engineering GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT03753256
Brief Title
Evaluation of Optical Coherence Tomography in Dentistry
Official Title
Evaluation of Optical Coherence Tomography in Dentistry
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Recruiting
Study Start Date
December 4, 2017 (Actual)
Primary Completion Date
August 2019 (Anticipated)
Study Completion Date
December 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Heidelberg Medical Center
Collaborators
Heidelberg Engineering GmbH

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries, Tooth Demineralization

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Transbond XT
Arm Type
Active Comparator
Arm Description
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 the development of demineralization its adverse effects after application
Arm Title
Protecto®CaF2Nano
Arm Type
Experimental
Arm Description
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 its abrasion behavior and the development of demineralization its adverse effects after the application
Arm Title
Pro Seal®
Arm Type
Experimental
Arm Description
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 its abrasion behavior and the development of demineralization its adverse effects after the application
Arm Title
Opal® Seal
Arm Type
Experimental
Arm Description
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 its abrasion behavior and the development of demineralization its adverse effects after the application
Intervention Type
Device
Intervention Name(s)
Transbond XT
Intervention Description
Application of • Transbond XT (activator comparator) to labial surfaces of teeth of randomized quadrants.
Intervention Type
Device
Intervention Name(s)
Protecto®CaF2Nano
Intervention Description
Application of • Protecto®CaF2Nano (orthodontic surface sealant) to labial surfaces of teeth of randomized quadrants.
Intervention Type
Device
Intervention Name(s)
Pro Seal®
Intervention Description
Application of • Protecto®CaF2Nano (orthodontic surface sealant) to labial surfaces of teeth of randomized quadrants.
Intervention Type
Device
Intervention Name(s)
Opal®Seal
Intervention Description
Application of • Opal®Seal (orthodontic surface sealant) to labial surfaces of teeth of randomized quadrants.
Primary Outcome Measure Information:
Title
Abrasion behaviour of orthodontic surface sealants
Description
Longitudinal assesment of surface sealant thickness using optical coherence tomography
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)
Secondary Outcome Measure Information:
Title
Adverse effects of orthodontic surface sealants
Description
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.
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sinan Sen, Dr.
Phone
0049622156
Ext
6583
Email
sinan.sen@med.uni-heidelberg.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sinan Sen, Dr.
Organizational Affiliation
Department of Orthodontics and Dentofacial Orthopaedics, University of Heidelberg
Official's Role
Study Director
Facility Information:
Facility Name
Department of Orthodontics and Dentofacial Orthopaedics, University of Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sinan Sen, Dr.
Phone
0049622156
Ext
6583
Email
sinan.sen@med.uni-heidelberg.de
First Name & Middle Initial & Last Name & Degree
Sebastian Zingler, Dr.
Phone
004956
Ext
36565
Email
sebastian.zingler@med.uni-heidelberg.de

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25748465
Citation
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.
Results Reference
result
PubMed Identifier
4544493
Citation
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.
Results Reference
result
PubMed Identifier
21228118
Citation
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.
Results Reference
result
PubMed Identifier
26168856
Citation
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.
Results Reference
result
PubMed Identifier
26312977
Citation
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.
Results Reference
result
PubMed Identifier
26419674
Citation
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. Erratum In: Clin Oral Investig. 2016 Nov;20(8):2323.
Results Reference
result
PubMed Identifier
32789656
Citation
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.
Results Reference
derived
PubMed Identifier
31765473
Citation
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. 2019 Nov 25:cjz096. doi: 10.1093/ejo/cjz096. Online ahead of print.
Results Reference
derived

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Evaluation of Optical Coherence Tomography in Dentistry

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