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

Comparison of Two Universal Composites in Posterior Teeth

30. august 2016 opdateret af: Zeynep Bilge Kutuk, Hacettepe University

Prospective, Randomized, Controlled, Double Blind Trial of Two Universal Composites in Posterior Teeth

The aim of this randomized, prospective clinical study was to compare the clinical performance of a universal light-curing, ultra-fine particle hybrid composite with a new version of this product produced by the same manufacturer in Class 1 and Class 2 lesions.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

A total of 80 (13 Class 1 and 67 Class 2) lesions in 40 patients (21 females, 19 males) with ages ranging between 18-38 years (23.15±5.15) were either restored with Charisma or Charisma Classic (Heraeus Kulzer) in combination with an etch and rinse adhesive system (Gluma 2 Bond) under rubber dam isolation by two experienced operators according to the manufacturer's instructions. Two independent examiners, who were blinded to the composites used evaluated the restorations according to the FDI (World Dental Federation) criteria. Bite-wing radiographs and intraoral digital photographs were taken before and after treatment and at 6 months. The statistical analyses were carried out with McNemar, Pearson Chi-square and Cochran Q tests (p<0.05).

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

40

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Kalkun
      • Ankara, Kalkun, 06100
        • Hacettepe University School 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 38 år (Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • a need for at least two but not more than four posterior tooth-colored restorations
  • the presence of teeth to be restored in occlusion
  • teeth that were symptomless and vital
  • a normal periodontal status
  • a good likelihood of recall availability.

Exclusion Criteria:

  • partly erupted teeth
  • absence of adjacent and antagonist teeth
  • poor periodontal status
  • adverse medical history
  • potential behavioral problems.

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: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Charisma
applied randomly
Andet: Charisma

The surfaces were etched using 35% phosphoric acid for 30 s. The etched surfaces were rinsed and dried. Charisma was used in combination Gluma2 Bond etch&rinse adhesive. The composite resin restorations were light-cured (600 milliwatt/cm²). Occlusion was checked with thin articulating papers.

Restoration surfaces were finished and polished with fine finishing diamond burs, stones and rubber cups.

Andre navne:
  • universal composite
Aktiv komparator: Charisma classic
applied randomly
Andet: Charisma Classic

The surfaces were etched using 35% phosphoric acid for 30 s. The etched surfaces were rinsed and dried. Charisma classic was used in combination Gluma2 Bond etch&rinse adhesive. The composite resin restorations were light-cured (600 milliwatt/cm²). Occlusion was checked with thin articulating papers.

Restoration surfaces were finished and polished with fine finishing diamond burs, stones and rubber cups.

Andre navne:
  • universal composite

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Observers evaluated the esthetic properties of the restorations using FDI (World Dental Federation) Criteria.
Tidsramme: The changes at restorations were obtained from baseline (one week after treatment), 6 month, 1, 2, 3 and 4 year.
"Surface luster"; "Staining (surface, margins)"; "Color match and translucency"; "Esthetic anatomical form"
The changes at restorations were obtained from baseline (one week after treatment), 6 month, 1, 2, 3 and 4 year.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Observers evaluated the functional properties of the restorations using FDI (World Dental Federation) Criteria.
Tidsramme: The changes at restorations were obtained from baseline (one week after treatment), 6 month, 1, 2, 3 and 4 year.
"Fracture of material and retention"; "Marginal adaptation"
The changes at restorations were obtained from baseline (one week after treatment), 6 month, 1, 2, 3 and 4 year.

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Observers evaluated the biological properties of the restorations using FDI (World Dental Federation) Criteria.
Tidsramme: The changes at restorations were obtained from baseline (one week after treatment), 6 month, 1, 2, 3 and 4 year.
"Recurrence of caries, erosion, abfraction"; and "Tooth integrity (enamel cracks, tooth fractures)"
The changes at restorations were obtained from baseline (one week after treatment), 6 month, 1, 2, 3 and 4 year.

Samarbejdspartnere og efterforskere

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

Sponsor

Hacettepe University

Efterforskere

  • Studieleder: Sevil Gurgan, DDS, PhD, Hacettepe University School 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.

Generelle publikationer

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

1. maj 2014

Primær færdiggørelse (Faktiske)

1. maj 2016

Studieafslutning (Faktiske)

1. maj 2016

Datoer for studieregistrering

Først indsendt

24. august 2016

Først indsendt, der opfyldte QC-kriterier

30. august 2016

Først opslået (Skøn)

5. september 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

5. september 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. august 2016

Sidst verificeret

1. august 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2014/03-13(KA-14005)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

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 .

Kliniske forsøg med Caries i tænderne

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Cameroon

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner