- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
São Paulo
-
Barueri, São Paulo, Brésil
- Complexo Educacional Carlos Osmarinho de Lima - Trailer USP
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Comparateur actif: 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.
|
Expérimental: ART using Fuji IX
Occlusal and occlusoproximal ART restorations in primary molars with GIC Fuji IX
|
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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
The restoration survival
Délai: 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.
|
Every 6 months up to 24 months.
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Cost-efficacy assessment
Délai: 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
Délai: 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.
|
Immediately after treatment
|
Cooperation
Délai: Immediately after treatment
|
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.
|
Immediately after treatment
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chaise d'étude: Daniela P Raggio, PhD, University of Sao Paulo
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- RECART
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
Essais cliniques sur Caries dentaires
-
IRCCS Azienda Ospedaliero-Universitaria di BolognaRecrutementComplications de la thérapie CAR-TItalie
-
The Lymphoma Academic Research OrganisationNovartis; Gilead SciencesRecrutementÉligible en hématopathologie ou traitement CAR-t CellFrance
-
Shanghai International Medical CenterInconnueTumeur solide avancée | PD-1 Anticorps | Cellules CAR-TChine
-
Ningbo Cancer HospitalInconnueMalignités avancées | PD-1 Anticorps | Cellules CAR-TChine
-
Stiftung Swiss Tumor InstituteKlinik Hirslanden, Zurich; Palleos Healthcare GmbHRecrutementMesures des résultats rapportés par les patients | Thérapie CAR T-CellSuisse
-
Merz Pharmaceuticals GmbHComplétéN/A, car aucune condition médicale spécifique ne sera traitéeAllemagne
-
Henan Cancer HospitalFundamenta Therapeutics, Ltd.Pas encore de recrutementAllogénique, CAR-T, séquestration de protéines, non modifié par des gènesChine
-
Ruijin HospitalRecrutement
-
Shanghai General Hospital, Shanghai Jiao Tong University...RecrutementCellule CAR-T | Ph Positif TOUS | DasatinibChine
-
Insel Gruppe AG, University Hospital BernRecrutementImmunité vaccinale chez les receveurs de thérapie cellulaire CAR-TSuisse
Essais cliniques sur Conventional Treatment
-
Columbia UniversityNeurolutions, Inc.RetiréAccident vasculaire cérébral | Hémiparésie
-
Hospital Clinic of BarcelonaInconnue
-
University of MichiganWallace H Coulter Center for Translational ResearchComplété
-
Emory UniversityNational Heart, Lung, and Blood Institute (NHLBI)Complété
-
Memorial Sloan Kettering Cancer CenterRésiliéLes familles ou proches parents des patients traités au MSKCC pour des carcinomes épidermoïdes non cutanés du | Voies aérodigestives supérieuresÉtats-Unis
-
University of PaviaActif, ne recrute pasReflux gastro-oesophagien | Érosion dentaireItalie
-
Medical University of South CarolinaNational Institute on Drug Abuse (NIDA); The Emmes Company, LLC; National Drug...ComplétéSurdose d'opioïdesÉtats-Unis
-
University of OklahomaComplétéGain de poids | Trouble de l'alimentation Néonatal | Nourrisson de très faible poids à la naissanceÉtats-Unis
-
University of GlasgowComplétéLa maladie de Crohn | Modification alimentaireRoyaume-Uni
-
Galderma R&DComplétéLes rides | Plis Nasolabiaux | Lignes de marionnettes