Evidence map›Paper›PMID 32789656›Full record

Trial reportClinical oral investigations2021

OCT evaluation of orthodontic surface sealants: a 12-month follow-up randomized clinical trial.

Sinan Şen, Ralf Erber, Gül Orhan, Sebastian Zingler, Christopher J Lux

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Clinical oral investigations, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03753256 (Evaluation of Optical Coherence Tomography in Dentistry), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.2field-weighted citation impact, top 46% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03753256 narecruitingnot on this map

Evaluation of Optical Coherence Tomography in Dentistry

TypeinterventionalSponsorUniversity of Heidelberg Medical CenterRan2017 to 2027Enrolled20ConditionsDental Caries, Tooth DemineralizationArmsTransbond XT, Protecto®CaF2Nano, Pro Seal®, Opal®Seal
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 3 citations in OpenAlex.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 1 institution in 1 country.

Sinan ŞenDepartment of Orthodontics and Dentofacial Orthopaedics, University of Heidelberg, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany. sinan.sen@med.uni-heidelberg.de.ORCID https://orcid.org/0000-0001-5907-5398
Ralf ErberDepartment of Orthodontics and Dentofacial Orthopaedics, University of Heidelberg, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany.
Gül OrhanDepartment of Orthodontics and Dentofacial Orthopaedics, University of Heidelberg, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany.
Sebastian ZinglerDepartment of Orthodontics and Dentofacial Orthopaedics, University of Heidelberg, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany.
Christopher J LuxDepartment of Orthodontics and Dentofacial Orthopaedics, University of Heidelberg, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany.
Heidelberg University · DE

Funding

German Society of Orthodontics DGKFO 113/1016Medizinischen Fakultät Heidelberg, Universität Heidelberg Physician Scientist Fellowship Program
6 · The paper itself

Abstract

objectivesThe aim of this single-center randomized controlled trial (NCT03753256) was to assess orthodontic surface sealant layer thickness and integrity in vivo during a 12-month follow-up by optical coherence tomography (OCT). MATERIALS AND

methodsUsing a split-mouth design, quadrants of 20 patients treated with fixed orthodontic appliances were included. Quadrants were randomly assigned to the sealants Pro Seal® (PS) or Opal® Seal™ (OS). OCT scans were performed immediately after the application of the sealants and after 3, 6, 9, and 12 months. Sealant layer thicknesses and their integrity were determined at 5 regions of interest (ROIs) known for high risks of demineralization. Sealant integrity loss was determined using a self-developed scale.

resultsA total of 16 patients successfully completed the study. The studied sealants showed significant differences in initial layer thickness. Mean layer thickness was significantly lower for PS (67.8 μm, (95% CI, 56.1-79.5)) than for OS (110.7 μm, (95% CI, 97.3-124.1)). Layer thickness loss was significant after 3 months for PS and after 6 months for OS. Sealant integrity was compromised in more than 50% of the ROIs already after 3 months for both sealants.

conclusionsPatients treated with fixed orthodontic surface sealants lost the integrity of the protective layer in more than 50% of cases after 3 months, and the layer thickness of the sealants was significantly reduced after 3-6 months. CLINICAL RELEVANCE: The protective effect against demineralization lesions of orthodontic sealants in patients treated with fixed appliances appears to be limited in time. Further preventive measures should be investigated.

trial registrationClinicalTrials.gov (NCT03753256).

Indexed as

Pit and Fissure SealantsTomography, Optical CoherenceFollow-Up StudiesHumansPit and Fissure SealantsAbrasionDemineralizationOrthodontic treatmentSurface sealantsTooth cleaning procedures

Identifiers

PMID32789656
PMCPMC7878257
OpenAlexW3048689425

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.