NCT03753256

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
19mo left

Started Dec 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress84%
Dec 2017Dec 2027

First Submitted

Initial submission to the registry

April 20, 2016

Completed
1.6 years until next milestone

Study Start

First participant enrolled

December 4, 2017

Completed
12 months until next milestone

First Posted

Study publicly available on registry

November 26, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
8.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Expected
Last Updated

November 28, 2018

Status Verified

November 1, 2018

Enrollment Period

1.7 years

First QC Date

April 20, 2016

Last Update Submit

November 26, 2018

Conditions

Dental CariesTooth Demineralization

Outcome Measures

Primary Outcomes (1)

  • Abrasion behaviour of orthodontic surface sealants

    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 Outcomes (1)

  • Adverse effects of orthodontic surface sealants

    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.

Study Arms (4)

Transbond XT

ACTIVE COMPARATOR

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

Protecto®CaF2Nano

EXPERIMENTAL

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

Pro Seal®

EXPERIMENTAL

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®

Opal® Seal

EXPERIMENTAL

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

Interventions

Transbond XTDEVICE

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

Transbond XT
Protecto®CaF2NanoDEVICE

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

Protecto®CaF2Nano
Pro Seal®DEVICE

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

Pro Seal®
Opal®SealDEVICE

Application of • Opal®Seal (orthodontic surface sealant) to labial surfaces of teeth of randomized quadrants.

Opal® Seal

Eligibility Criteria

Age6 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • withdrawn consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Orthodontics and Dentofacial Orthopaedics, University of Heidelberg

Heidelberg, 69120, Germany

RECRUITING

Related Publications (8)

  • 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: 25748465RESULT

  • 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: 4544493RESULT

  • 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: 21228118RESULT

  • 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: 26168856RESULT

  • 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: 26312977RESULT

  • 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: 26419674RESULT

  • 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: 32789656DERIVED

  • 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: 31765473DERIVED

MeSH Terms

Conditions

Dental CariesTooth Demineralization

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Study Officials

  • Sinan Sen, Dr.

    Department of Orthodontics and Dentofacial Orthopaedics, University of Heidelberg

    STUDY DIRECTOR

Central Study Contacts

Sinan Sen, Dr.

CONTACT

0049622156sinan.sen@med.uni-heidelberg.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Teaching and Research Assistant

Study Record Dates

First Submitted

April 20, 2016

First Posted

November 26, 2018

Study Start

December 4, 2017

Primary Completion

August 1, 2019

Study Completion (Estimated)

December 1, 2027

Last Updated

November 28, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)