Evaluation of Optical Coherence Tomography in Dentistry

November 26, 2018 updated by: Sinan Sen, University of Heidelberg Medical Center
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SCREENING
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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 Measures

Outcome Measure
Measure Description
Time Frame
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Heidelberg Medical Center

Collaborators

Heidelberg Engineering GmbH

Investigators

  • Study Director: Sinan Sen, Dr., Department of Orthodontics and Dentofacial Orthopaedics, University of Heidelberg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 4, 2017

Primary Completion (ANTICIPATED)

August 1, 2019

Study Completion (ANTICIPATED)

December 1, 2027

Study Registration Dates

First Submitted

April 20, 2016

First Submitted That Met QC Criteria

November 23, 2018

First Posted (ACTUAL)

November 26, 2018

Study Record Updates

Last Update Posted (ACTUAL)

November 28, 2018

Last Update Submitted That Met QC Criteria

November 26, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S-370/2015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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