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Laser Etching Effect on Application Mode of Universal Adhesive

25. mars 2021 oppdatert av: A Ruya Yazici, Hacettepe University

Clinical Evaluation of Cervical Composite Restorations Placed Using Universal Adhesive in Different Modes and Different Etching Methods

To evaluate the clinical performance of the restorations by applying the universal adhesive in different modes under the influence of different surface treatments, with Erbium Chromium:Yttrium-Scandium-Gallium-Garnet (Er,Cr:YSGG) laser and acid etching in non-carious cervical lesions.

Studieoversikt

Status

Aktiv, ikke rekrutterende

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Forty-one patients (at least five non-carious cervical lesions) have participated in this study. The non-carious cervical lesions in each patient were divided into five groups (total-etch mode with phosphoric acid, selective-etch mode with phosphoric acid, total-etch mode with laser, selective-etch mode with laser and self-etch mode) according to different modes and application methods of universal adhesive (Clearfil Universal Bond Quick, Kuraray). Lesions were restored with a resin composite, Clearfil Majesty ES-2 (Kuraray). All restorative procedures were performed by a single operator. Restorations were evaluated at one week (baseline), at 6-, 12-, 18- and 24-month according to modified USPHS criteria (retention, marginal discoloration, marginal adaptation, color match, postoperative sensitivity, and secondary caries) by two experienced and calibrated investigators.

Studietype

Intervensjonell

Registrering (Faktiske)

41

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Tyrkia
      • Ankara, Tyrkia, 06100
        • Hacettepe University Faculty of Dentistry

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 75 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Participants were 18 years of age or older,
  • no possible health problems (such as allergies) related to resin-based restorations,
  • good general health,
  • having at least five non-carious cervical lesions.
  • The depth of the lesions were at least 1 mm, without carious, not previously restored, having teeth with vital, enamel and dentin tissue.

Exclusion Criteria

  • Participant had fewer than 20 teeth,
  • having poor oral hygiene,
  • uncontrolled periodontal disease,
  • xerostomia,
  • pregnancy or breastfeeding possible health problems (such as allergy) related to resin-based restorations,
  • having bleaching treatment or orthodontic treatment.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Annen: Group I
Total-etch mode with 35% phosphoric acid
Fremgangsmåte: Total-etch mode with 35% phosphoric acid (K-ETCHANT) (TE-A group)
35% phosphoric acid was applied to enamel and dentin for 10 s, washed and dried for 5 s. The universal adhesive, Clearfil Universal Bond Quick (CBQ) was applied to enamel and dentin surfaces with a single-use applicator, then gently air-dried for 5 s without waiting, and light-cured for 10 s.
Annen: Group II
Selective-etch mode with 35% phosphoric acid
Fremgangsmåte: Selective-etch mode with 35% phosphoric acid (K-ETCHANT) (SE-A group)
35% phosphoric acid was used only on enamel for 10 s, then washed and dried for 5 seconds. Subsequently, the adhesive was applied in a similar manner to the TE-A group.
Annen: Group III
Total-etch mode with laser (Er,Cr:YSGG)
Fremgangsmåte: Total-etch mode with Er, Cr: YSGG laser (Waterlase MD) (TE-L group)
the enamel margin and dentin surfaces of lesions were irradiated with an Er,Cr:YSGG laser (2780 nm, Waterlase MD, BioLase Technology, Inc., San Clemente, CA). Then the adhesive was applied in a similar manner to the TE-A group.
Annen: Group IV
Selective-etch mode with laser (Er,Cr:YSGG)
Fremgangsmåte: Selective-etch mode with Er, Cr: YSGG laser (Waterlase MD) (SE-L group).
The laser system was applied in the same way as described in the TE-L group only on enamel surface. Subsequently, the adhesive was applied in the same way as described in the TE-A group.
Annen: Group V
Self-etch mode
Fremgangsmåte: Self-etch mode Clearfil Universal Bond Quick (Kuraray, Japan) (SE group)
Universal adhesive system (CBQ) was applied to enamel and dentin surfaces without any previous etching. Then gently air-dried for 5 s without waiting, and light-cured for 10 s.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Retention,
Tidsramme: From baseline to 2 year the change of restorations was evaluated

The retention criterion determines how long a restorative material functions in the oral environment, it is the most important criterion that shows the success of the material.

Alpha: The restoration is present. Charlie: The restoration is absent.
From baseline to 2 year the change of restorations was evaluated
Marginal Discoloration
Tidsramme: From baseline to 2 year the change of restorations was evaluated

The marginal discoloration that occur at the edge staining restoration boundaries are generally thought to be due to microleakage.

Alpha: No discoloration at margins. Bravo: Shallow discoloration, clinically acceptable. Charlie: Deep discoloration clinically unacceptable.
From baseline to 2 year the change of restorations was evaluated
Marginal Adaptation
Tidsramme: From baseline to 2 year the change of restorations was evaluated

Marginal adaptation is achieved by fully ensuring the integrity of the tooth-restoration joint border.

Alpha: Restoration is closely adapted to the tooth. Bravo: Visible evidence of a crevice along the margin, dentin not exposed, clinically acceptable.

Charlie: Explorer penetrates into crevice, dentin is exposed; clinically unacceptable.
From baseline to 2 year the change of restorations was evaluated
Color match
Tidsramme: From baseline to 2 year the change of restorations was evaluated

Color match is the evaluation of the restoration according to the darkening or lightening of the color, taking into account the tooth tissue surrounding restoration.

Alpha:Matches tooth. Bravo: Acceptable mismatch. Charlie:Unacceptable mismatch.
From baseline to 2 year the change of restorations was evaluated
Post-op Hypersensitivity
Tidsramme: From baseline to 2 year the change of restorations was evaluated
Determination of sensitivity after restorations are placed. Alpha: Absent. Charlie: Present; clinically unacceptable.
From baseline to 2 year the change of restorations was evaluated
Secondary Caries
Tidsramme: From baseline to 2 year the change of restorations was evaluated

Secondary caries is the progression of caries in the tooth tissue adjacent to the restorations. Caries formation means restoration failure.

Alpha: Absent. Charlie: Present; clinically unacceptable.
From baseline to 2 year the change of restorations was evaluated

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Hacettepe University

Etterforskere

  • Hovedetterforsker: A. Ruya Yazici, Hacettepe University Faculty of Dentistry

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

10. juli 2019

Primær fullføring (Faktiske)

10. januar 2021

Studiet fullført (Forventet)

25. mars 2025

Datoer for studieregistrering

Først innsendt

11. mars 2021

Først innsendt som oppfylte QC-kriteriene

23. mars 2021

Først lagt ut (Faktiske)

24. mars 2021

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

26. mars 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

25. mars 2021

Sist bekreftet

1. mars 2021

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • KA180076

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

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