Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Laser Etching Effect on Application Mode of Universal Adhesive

25. marts 2021 opdateret af: 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.

Studieoversigt

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

41

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Andet: Group I
Total-etch mode with 35% phosphoric acid
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.
Andet: Group II
Selective-etch mode with 35% phosphoric acid
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.
Andet: Group III
Total-etch mode with laser (Er,Cr:YSGG)
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.
Andet: Group IV
Selective-etch mode with laser (Er,Cr:YSGG)
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.
Andet: Group V
Self-etch mode
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

10. juli 2019

Primær færdiggørelse (Faktiske)

10. januar 2021

Studieafslutning (Forventet)

25. marts 2025

Datoer for studieregistrering

Først indsendt

11. marts 2021

Først indsendt, der opfyldte QC-kriterier

23. marts 2021

Først opslået (Faktiske)

24. marts 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

26. marts 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. marts 2021

Sidst verificeret

1. marts 2021

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • KA180076

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner