- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02888873
Comparison of Two Universal Composites in Posterior Teeth
Prospective, Randomized, Controlled, Double Blind Trial of Two Universal Composites in Posterior Teeth
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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-
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Ankara, Tyrkia, 06100
- Hacettepe University School of Dentistry
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Aktiv komparator: Charisma
applied randomly
|
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 navn:
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Aktiv komparator: Charisma classic
applied randomly
|
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 navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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.
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"Surface luster"; "Staining (surface, margins)"; "Color match and translucency"; "Esthetic anatomical form"
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The changes at restorations were obtained from baseline (one week after treatment), 6 month, 1, 2, 3 and 4 year.
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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.
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"Fracture of material and retention"; "Marginal adaptation"
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The changes at restorations were obtained from baseline (one week after treatment), 6 month, 1, 2, 3 and 4 year.
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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.
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"Recurrence of caries, erosion, abfraction"; and "Tooth integrity (enamel cracks, tooth fractures)"
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The changes at restorations were obtained from baseline (one week after treatment), 6 month, 1, 2, 3 and 4 year.
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studieleder: Sevil Gurgan, DDS, PhD, Hacettepe University School of Dentistry
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Gurgan S, Vural UK, Kutuk ZB, Cakir FY. Comparison of two universal composites in posterior teeth: preliminary report. J Dent Res (Spec Iss 94 B): 308, 2015
- Gurgan S, Koc Vural U, Kutuk ZB, Cakir FY. Does a new formula have an input in the clinical success of posterior composite restorations? A chat study. Clin Oral Investig. 2021 Apr;25(4):1715-1727. doi: 10.1007/s00784-020-03472-5. Epub 2020 Aug 3.
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2014/03-13(KA-14005)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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