- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04814836
Laser Etching Effect on Application Mode of Universal Adhesive
Clinical Evaluation of Cervical Composite Restorations Placed Using Universal Adhesive in Different Modes and Different Etching Methods
Studieoversigt
Status
Betingelser
Intervention / Behandling
- Procedure: Total-etch mode with 35% phosphoric acid (K-ETCHANT) (TE-A group)
- Procedure: Selective-etch mode with 35% phosphoric acid (K-ETCHANT) (SE-A group)
- Procedure: Total-etch mode with Er, Cr: YSGG laser (Waterlase MD) (TE-L group)
- Procedure: Selective-etch mode with Er, Cr: YSGG laser (Waterlase MD) (SE-L group).
- Procedure: Self-etch mode Clearfil Universal Bond Quick (Kuraray, Japan) (SE group)
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
-
Ankara, Kalkun, 06100
- Hacettepe University Faculty of Dentistry
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
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
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
Sponsor
Efterforskere
- Ledende efterforsker: A. Ruya Yazici, Hacettepe University Faculty of Dentistry
Publikationer og nyttige links
Generelle publikationer
- Atalay C, Uslu A, Yazici AR. Does laser etching have an effect on application mode of a universal adhesive?-A microleakage and scanning electron microscopy evaluation. Microsc Res Tech. 2021 Jan;84(1):125-132. doi: 10.1002/jemt.23573. Epub 2020 Aug 27.
- Atalay C, Ozgunaltay G, Yazici AR. Thirty-six-month clinical evaluation of different adhesive strategies of a universal adhesive. Clin Oral Investig. 2020 Apr;24(4):1569-1578. doi: 10.1007/s00784-019-03052-2. Epub 2019 Aug 30.
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- KA180076
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
produkt fremstillet i og eksporteret fra U.S.A.
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 .