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Dental CariesNCT03753256

Evaluation of Optical Coherence Tomography in Dentistry

A study testing Transbond XT, Protecto®CaF2Nano and Pro Seal® in people with Dental Caries and Tooth Demineralization, run by University of Heidelberg Medical Center at 1 site in Germany.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 6 years and older
Conditions the study is for
Dental Caries, Tooth Demineralization
What is being tested?
Transbond XT, Protecto®CaF2Nano and Pro Seal®
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteGermany
Study dates
4 Dec 2017to Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

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

Who cannot join

  • withdrawn consent

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Sinan Sen, Dr. contact

0049622156 ext. 6583

sinan.sen@med.uni-heidelberg.de

Germany1 site, 1 recruiting

  • Department of Orthodontics and Dentofacial Orthopaedics, University of Heidelberg

    Heidelberg, 69120

    Sinan Sen, Dr., 0049622156 ext. 6583, sinan.sen@med.uni-heidelberg.de

    Sebastian Zingler, Dr., 004956 ext. 36565, sebastian.zingler@med.uni-heidelberg.de

    Recruiting

Other trials in Germany

About this study

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.

Read the 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.

Being tested
Transbond XT, Protecto®CaF2Nano, Pro Seal®, Opal®Seal
Medical subject headings
Dental Caries, Tooth Demineralization

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transbond XTDevice

    Application of

    • Transbond XT (activator comparator) to labial surfaces of teeth of randomized quadrants.

  • Protecto®CaF2NanoDevice

    Application of

    • Protecto®CaF2Nano (orthodontic surface sealant) to labial surfaces of teeth of randomized quadrants.

  • Pro Seal®Device

    Application of

    • Protecto®CaF2Nano (orthodontic surface sealant) to labial surfaces of teeth of randomized quadrants.

  • Opal®SealDevice

    Application of

    • Opal®Seal (orthodontic surface sealant) to labial surfaces of teeth of randomized quadrants.
Study groups in NCT03753256
Study groupRoleWhat they receive
Transbond XTActive comparatorApplication 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
Receives: Device: Transbond XT
Protecto®CaF2NanoExperimentalApplication 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
Receives: Device: Protecto®CaF2Nano
Pro Seal®ExperimentalApplication 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
Receives: Device: Pro Seal®
Opal® SealExperimentalApplication 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
Receives: Device: Opal®Seal

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Abrasion behaviour of orthodontic surface sealants

    Longitudinal assesment of surface sealant thickness using optical coherence tomography

    Measured: 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 outcomes (1)

  1. 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.

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Nov 2018
  2. Study start4 Dec 2017
  3. Primary completionAug 2019 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03753256
Sponsor's protocol ID
S-370/2015
Status last verified
Nov 2018
First submitted
20 Apr 2016
Last updated
28 Nov 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 31765473

Questions about this trial

What is this clinical trial studying?

A study testing Transbond XT, Protecto®CaF2Nano and Pro Seal® in people with Dental Caries and Tooth Demineralization, run by University of Heidelberg Medical Center at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sinan Sen, Dr. (0049622156 ext. 6583, sinan.sen@med.uni-heidelberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03753256, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2018.

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