- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT02562456
Cost-efficacy Between ART and Composite Resin Restorations in Primary Molars
Difference of Cost-efficacy Between Atraumatic Restoration Treatment (ART) and Composite Resin Restorations in Primary Molars: A Randomized Clinical Trial
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Research setting
The study will be performed in a dental care trailer which simulated a regular dental office and it is located inside a public school of the city Barueri (São Paulo, Brazil).
Sample size calculation
For sample size calculation, data regarding longevity of CT in occlusal and occlusoproximal restorations after 2 years were extracted from the literature as 86% for occlusal and 60% for occlusoproximal restorations. A difference of 15% and 20% between the longevity of CT and ART was set as non-inferiority limit. Considering the level of significance as 5%, power as 80% and adding 40% due to the study design (cluster per child), a number of 204 occlusal restorations and 240 occlusoproximal restorations will be needed.
Randomization
The child will be the unit of randomization which means that all eligible teeth of a participant will be treated according the same restorative approach. Randomization list will be obtained using blocks of 4, 6 and 8 generated by software Sealed Envelope Ltd. Opaque, sealed and sequentially numbered envelopes will be used for randomizing all participants immediately before restorative treatments' beginning.
Allocation concealment
To assure allocation concealment, the participant will be randomized immediately before the treatment. When two or more cavities is available, preventing the finalization of the treatment in only one session, breach of allocation concealment will be signalized in the participants' record.
Blinding
Due to differences between the techniques, it will be not possible to blind operators, participants and evaluators.
Operators
All operators will be masters or PhD students from the Pediatric Dentistry Department, Faculty of Dentistry, University of São Paulo, previously trained. All procedures will be performed with the assistance of a dental student previously trained to manipulate all restorative materials.
Studientyp
Einschreibung (Voraussichtlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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-
São Paulo
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Barueri, São Paulo, Brasilien
- Complexo Educacional Carlos Osmarinho de Lima - Trailer USP
-
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Children aging between 3 and 6 years
- presenting good health conditions
- whose parents or legal guardians accept and sign the consent form
- with at least one occlusal or occlusal proximal caries lesion in primary molars
- only occlusal and/or occlusal-proximal surfaces with caries lesions with dentin involvement
Exclusion Criteria:
- severe behavioral issues
- presence of fistula or abscess near the selected tooth
- presence of pulp exposure in the selected tooth
- presence of mobility in the selected tooth
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Aktiver Komparator: Conventional Treatment
Occlusal and occlusoproximal composite resin restorations in primary molars (rubber dam isolation + Adhesive system + composite resin Filtek z350)
|
Occlusal and occlusoproximal composite resin restorations in primary molars using the Scotchbond Multi-purpose adhesive system and the Filtek Z-350 composite resin wil be performed.
Local anesthesia will be used.
Absolute isolation will be performed using rubber dam and clamp.
Removal of unsupported enamel will be performed using a round bur.
Infected carious tissue will be removed with hand instruments.
The cavity will be etched using 37% phosphoric acid for 15 seconds followed by rising and drying for the same amount of time.
The cavity will be restored with composite resin.
Occlusion will be checked.
an adapted matrix strip with a wooden wedge will be used to assure appropriate contour.
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Experimental: ART using Fuji IX
Occlusal and occlusoproximal ART restorations in primary molars with GIC Fuji IX
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Occlusal and occlusoproximal ART restorations in primary molars using the high viscosity GIC Fuji IX will be performed under relative isolation.
No local anesthesia will be used.
Infected carious tissue will be removed with hand instruments, and the cavities restored with GIC.
After the press-finger technique, the excess of material will be removed and occlusion will be checked.
For occlusoproximal restoration, an adapted matrix strip with a wooden wedge will be used to assure appropriate contour.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
The restoration survival
Zeitfenster: Every 6 months up to 24 months.
|
The treatments will be classified as successful when they present a clinical satisfactory aspect.
Otherwise, "minor failures" will be analyzed.
"Minor failures" are those in which there is a defect in the restoration/crown, but it does not interfere with the tooth health.
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Every 6 months up to 24 months.
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Cost-efficacy assessment
Zeitfenster: Through study completion, an average of 24 months
|
Treatment costs = professional costs + procedure costs.
If the restorative treatment requires repairs, the additional cost of it will also be considered. |
Through study completion, an average of 24 months
|
Child self-reported discomfort
Zeitfenster: Immediately after treatment
|
The acceptability of each type of treatment will be evaluated using the Facial scale of Wong-Baker (Wong; Baker, 1998).
This scale indicates the discomfort of an individual who has to choose among six faces, each one expressing different facial countenance.
The first image is a smiling happy face, indicating no discomfort, followed by gradually less cheerful expressions, up to the last one which is a very sad face covered by tears, indicating great discomfort.
The participant will be asked to choose the face that is more similar to how he or she felt during the treatment.
This answer should be given solely by the child, which means, no parental or professional interferences.
The facial scale of Wong-Baker will be applied right after the end of each restorative treatment session.
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Immediately after treatment
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Cooperation
Zeitfenster: Immediately after treatment
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Cooperation will be evaluated by the operator immediately after the end of the treatment using a 5-point scale: 1- Good behaviour, 2- Reasonable behaviour, 3- Indiferent, 4- Bad behaviour, 5- Really bad behaviour.
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Immediately after treatment
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Studienstuhl: Daniela P Raggio, PhD, University of Sao Paulo
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Voraussichtlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- RECART
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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