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Efficacy of a new sealant to prevent white spot lesions during fixed orthodontic treatment

A 12-month, single-center, randomized controlled clinical trial

Wirksamkeit eines neuen Versieglers zur Prävention von White-Spot-Läsionen während einer kieferorthopädischen Behandlung mit festsitzenden Apparaturen

Monozentrische randomisierte kontrollierte klinische Studie über 12 Monate

  • Original Article
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Journal of Orofacial Orthopedics / Fortschritte der Kieferorthopädie Aims and scope Submit manuscript

Abstract

Background and objective

White spot lesions (WSLs) are an undesirable side effect of fixed orthodontic appliance therapy and are reported to occur in 2–96 % of orthodontic patients. In this study, the efficacy of a new sealant to prevent WSLs during fixed orthodontic treatment was compared to a control group that did not receive sealant.

Patients and methods

For this 2-arm parallel-group randomized trial, 50 subjects aged 12–18 years (mean age 14.57 ± 2.04 years) were recruited from the orthodontics department at Mansoura University, Egypt. Eligibility criteria were no restorations, no active WSLs or caries, and adequate oral hygiene. Subjects were randomized in a 1:1 ratio to one of the two arms prior to undergoing fixed orthodontic treatment, namely a single application of SeLECT Defense™ sealant during the bracketing appointment or no sealant (control arm). Instructions and dentifrices for local home fluoridation regimen were identical in both groups. Oral hygiene was assessed using the Approximal Plaque Index (API) at specified time intervals. Dental photographs were taken for blinded WSLs assessment; inter- and intra-operator error were also calculated. Categorical data were tested using the χ 2 test, and a logistic regression model was adopted to detect associations between decalcification (WSLs), sealant application, and oral hygiene status.

Results

Only excellent or good oral hygiene were independent prognostic factors for preventing severe WSLs (p = 0.035). No significant effect on caries incidence was observed for the sealant.

Conclusions

In combination with adequate oral hygiene SeLECT Defense™ helps to reduced the frequency of WSLs. However, the sealat showed no significant effect as sole preventive strategy.

Zusammenfassung

Hintergrund und Zielsetzung

White-Spot-Läsionen (WSLs) sind eine unerwünschte Nebenwirkung bei der Behandlung mit festsitzenden Apparaturen. Die Inzidenz bei KFO-Patienten wird zwischen 2 und 96 % angegeben. In der vorliegenden Studie wurde untersucht, wie wirksam ein neuer Versiegler zur WSL-Prävention ist. Dazu wurden 2 Patientengruppen die mit festsitzenden kieferorthopädischen Apparaturen behandelt wurden, miteinander verglichen, wobei nur bei einer Gruppe der Versiegler zur Anwendung kam.

Patienten und Methodens

In die 2-armige Studie mit randomisierten parallelen Gruppen wurden in der Abteilung für Kieferorthopädie der Mansoura University, Ägypten, 50 Probanden zwischen 12 und 18 Jahren (Durchschnitt 14,57 ± 2,04 Jahre) rekrutiert. Einschlusskriterien waren: keine zahnärztlichen Restaurationen, keine aktiven WSL bzw. Karies und eine angemessene Mundhygiene. Vor Beginn der Behandlung mit einer festsitzenden Apparatur, also vor der Einzelanwendung bzw. der Nichtanwendung (Kontrollgruppe) von SeLECT Defense™ während der Bracketinsertion, wurden die Probanden im 1:1-Verhältnis randomisiert. Pflegeanweisungen und Zahncremes zur lokalen häuslichen Fluoridierung waren  in beiden Gruppen gleich. Die Qualität der Mundhygiene wurde zu bestimmten Zeitpunkten mittels API (Approximalraum-Plaque-Index) ermittelt. Für  die verblindete WSL-Bewertung wurden intraorale Fotographien erstellt. Inter- und Intrauntersucherfehler wurden ermittelt. Zur Evaluierung kategorialer Daten wurde der χ 2-Test verwendet, ein logistisches Regressionsmodell diente der Ermittlung von  Abhängigkeiten zwischen WSL, Versiegler und Mundhygienestatus.

Ergebnisse

Nur eine exzellente gute Mundhygiene erwiesen sich als unabhängige prognostische Prädiktoren für die Prävention gravierender WSLs (p = 0,035). Ein signifikanter Effekt auf die Kariesinzidenz durch den Versiegler ließ sich nicht beobachten.

Schlussfolgerungen

In Kombination mit angemessener Mundhygiene trägt der Versiegler dazu bei, die Frequenz von WSL zu verringern, als alleinige Präventionsstrategie hat er jedoch keinen signifikanten Effekt.

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Author information

Authors and Affiliations

  1. Department of Orthodontics, Faculty of Dentistry, Mansoura University, El Gomhoria Street, Mansoura, 35516, Egypt

    Shaza M. Hammad

  2. Department of Orthodontics, University Medical Center Göttingen (UMG), Göttingen, Germany

    Michael Knösel

  3. Private Orthodontic Practice, Hamburg, Germany

    Michael Knösel

  4. Department of Orthodontics, Universidad de La Frontera (UFRO), Temuco, Chile

    Michael Knösel

Authors
  1. Shaza M. Hammad
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  2. Michael Knösel
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Corresponding author

Correspondence to Shaza M. Hammad.

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Conflict of interest

S. M. Hammad and M. Knösel declare that they have no competing interest. All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. Informed consent was obtained from all individual participants included in the study.

Additional information

Shaza M. Hammad: Professor; Michael Knösel: Professor.

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Hammad, S.M., Knösel, M. Efficacy of a new sealant to prevent white spot lesions during fixed orthodontic treatment. J Orofac Orthop 77, 439–445 (2016). https://doi.org/10.1007/s00056-016-0052-2

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