Laser Etching Effect on Application Mode of Universal Adhesive
25 marzo 2021 aggiornato da: 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.
Panoramica dello studio
Stato
Attivo, non reclutante
Condizioni
Intervento / Trattamento
- Procedura: Total-etch mode with 35% phosphoric acid (K-ETCHANT) (TE-A group)
- Procedura: Selective-etch mode with 35% phosphoric acid (K-ETCHANT) (SE-A group)
- Procedura: Total-etch mode with Er, Cr: YSGG laser (Waterlase MD) (TE-L group)
- Procedura: Selective-etch mode with Er, Cr: YSGG laser (Waterlase MD) (SE-L group).
- Procedura: Self-etch mode Clearfil Universal Bond Quick (Kuraray, Japan) (SE group)
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
41
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Ankara, Tacchino, 06100
- Hacettepe University Faculty of Dentistry
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 18 anni a 75 anni (Adulto, Adulto più anziano)
Accetta volontari sani
Sì
Sessi ammissibili allo studio
Tutto
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Altro: Group I
Total-etch mode with 35% phosphoric acid
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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.
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Altro: Group II
Selective-etch mode with 35% phosphoric acid
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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.
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Altro: Group III
Total-etch mode with laser (Er,Cr:YSGG)
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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.
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Altro: Group IV
Selective-etch mode with laser (Er,Cr:YSGG)
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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.
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Altro: Group V
Self-etch mode
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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.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Retention,
Lasso di tempo: From baseline to 2 year the change of restorations was evaluated
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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
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Marginal Discoloration
Lasso di tempo: From baseline to 2 year the change of restorations was evaluated
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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
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Marginal Adaptation
Lasso di tempo: From baseline to 2 year the change of restorations was evaluated
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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
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Color match
Lasso di tempo: From baseline to 2 year the change of restorations was evaluated
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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
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Post-op Hypersensitivity
Lasso di tempo: From baseline to 2 year the change of restorations was evaluated
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Determination of sensitivity after restorations are placed.
Alpha: Absent.
Charlie: Present; clinically unacceptable.
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From baseline to 2 year the change of restorations was evaluated
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Secondary Caries
Lasso di tempo: From baseline to 2 year the change of restorations was evaluated
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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
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Investigatore principale: A. Ruya Yazici, Hacettepe University Faculty of Dentistry
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- 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.
Collegamenti utili
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
10 luglio 2019
Completamento primario (Effettivo)
10 gennaio 2021
Completamento dello studio (Anticipato)
25 marzo 2025
Date di iscrizione allo studio
Primo inviato
11 marzo 2021
Primo inviato che soddisfa i criteri di controllo qualità
23 marzo 2021
Primo Inserito (Effettivo)
24 marzo 2021
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
26 marzo 2021
Ultimo aggiornamento inviato che soddisfa i criteri QC
25 marzo 2021
Ultimo verificato
1 marzo 2021
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- KA180076
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
prodotto fabbricato ed esportato dagli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .