- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02778503
Effectiveness of Atraumatic Restorative Treatment Using Glass Ionomer Cement of Different Costs (SLM1797)
6. november 2017 oppdatert av: Jose Carlos P Imparato, Faculty Sao Leopoldo Mandic Campinas
Effectiveness of Atraumatic Restorative Treatment Using Glass Ionomer Cement of Different Costs: a Randomized Controlled Trial
Atraumatic Restorative Treatment (ART) is an alternative restorative technique for dental caries, applying the partial caries tissue removal philosophy using hand instruments, relative cotton rolls isolation, immediate restoration with Glass Ionomer Cements (GIC) and avoiding local anesthesia.
The chosen material for this study will be the High Viscosity Glass Ionomer Cement (HVGIC) due to its unique physical-chemical properties as well as its applicability in challenging clinical situations where other materials would not be adequate.
Although there are substantial evidences regarding GIC properties, information about GIC (with different costs) longevity is still weak.
Therefore, the objective of this study is to assess the effectiveness of ART restorations performed with low-cost HVGIC in cavitated dentine carious lesions in primary and permanent molars.
This will be a multicenter randomized controlled double-blind (patient and operator) clinical trial performed with 680 primary and/or permanent molars in children between 4 and 9 years old presenting cavitated dentine carious lesions in occlusal and occlusal-proximal surfaces.
The tooth will be considered as the unit sample, which will be randomly allocated to the groups through a generated random list numbers and distributed in dark sealed envelopes opened only by dental assistants.
Teeth in the test group will be submitted to restorative treatment with HVGIC Vitro Molar and those in the control group with HVGIC Fuji IX.
The restoration effectiveness will be assessed by means of both clinical and bitewing x-rays control after 6 and 12 months.
Studieoversikt
Studietype
Intervensjonell
Registrering (Faktiske)
574
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Sao Paulo
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Campinas, Sao Paulo, Brasil, 13045755
- Faculty Sao Leopoldo Mandic
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
4 år til 9 år (Barn)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Children with at least one primary and/or permanent molar with dentine carious lesion in the occlusal and/or occlusal-proximal surface.
Exclusion Criteria:
- Special need patients, subjects under orthodontic treatment and/or systemically compromised.
- Teeth with restorations, sealants, developmental defects, deep carious lesions with pulpal exposure risk, fistula and/or abscess, and those with history of spontaneous pain.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Aktiv komparator: High Cost
Restoration using a high-cost glass ionomer cement.
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Surfaces allocated to this group will be treated with a high-cost glass ionomer cement restoration (Fuji IX, GC America, USA), according to the manufacturer's instructions.
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Eksperimentell: Low Cost
Restoration using a low-cost glass ionomer cement.
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Surfaces allocated to this group will be treated with a low-cost glass ionomer cement restoration (Maxxion R, FGM, BRA), according to the manufacturer's instructions.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Restoration survival
Tidsramme: 12 months
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The restoration will be classified according to the scores described by Frencken et al. (1994) and Roeleveld et al. (2006).
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12 months
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Cost-effectiveness
Tidsramme: Through study completion (12 months)
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The costs of each treatment procedure will be calculated and compared with thresholds values for intervention cost-effectiveness by region, determined by World Health Organization (http://www.who.int/choice/costs/CER_levels/en/).
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Through study completion (12 months)
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Impact on children's quality of life
Tidsramme: Baseline and 12 months
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The oral health related quality of life will be measured using a validated questionnaire according to the children's age.
The "Early Childhood Oral Health Impact Scale" (ECOHIS) (Tesch et al., 2008) will be applied with 4-5 years old children.
The "Child Perceptions Questionnaire" (CPQ) will be used for 6-9 years old children (Martins et al., 2009).
They will be applied immediately before the procedure and on 12 months follow-up.
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Baseline and 12 months
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Children self-reported discomfort
Tidsramme: Baseline
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The discomfort of each treatment will be evaluated using the facial scale of Wong-Baker (Wong, Baker, 1988).
The patient will be asked to choose the face that is more similar to how he/she felt during the treatment.
The answer should be given solely by the child, which means no parental or professional interferences.
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Baseline
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Caries lesions progression
Tidsramme: Every 6 months up to 12 months
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The treatments will be evaluated radiographically.
This evaluation will be performed by two blinded examiners, which will evaluate the four patients' radiographies (baseline, after treatment, 6 months, 12 months) independently, two by two, without knowing the chronological order of them.
The efficacy of the treatment will be related to the presence or absence of increasing radiolucent area.
They will also classify each radiography using Ekstrand criteria (Ekstrand et al., 1997) and analyze them in a software (ImageJ 1.49, National Institute of Health, USA) in order to make the radiographic subtraction.
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Every 6 months up to 12 months
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Jose Carlos P Imparato, PhD, Faculty Sao Leopoldo Mandic
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Roeleveld AC, van Amerongen WE, Mandari GJ. Influence of residual caries and cervical gaps on the survival rate of Class II glass ionomer restorations. Eur Arch Paediatr Dent. 2006 Jun;7(2):85-91. doi: 10.1007/BF03320820.
- Frencken JE, Pilot T, Songpaisan Y, Phantumvanit P. Atraumatic restorative treatment (ART): rationale, technique, and development. J Public Health Dent. 1996;56(3 Spec No):135-40; discussion 161-3. doi: 10.1111/j.1752-7325.1996.tb02423.x.
- Tesch FC, Oliveira BH, Leao A. [Semantic equivalence of the Brazilian version of the Early Childhood Oral Health Impact Scale]. Cad Saude Publica. 2008 Aug;24(8):1897-909. doi: 10.1590/s0102-311x2008000800018. Portuguese.
- Martins MT, Ferreira FM, Oliveira AC, Paiva SM, Vale MP, Allison PJ, Pordeus IA. Preliminary validation of the Brazilian version of the Child Perceptions Questionnaire 8-10. Eur J Paediatr Dent. 2009 Sep;10(3):135-40.
- Wong DL, Baker CM. Pain in children: comparison of assessment scales. Pediatr Nurs. 1988 Jan-Feb;14(1):9-17. No abstract available.
- Ekstrand KR, Ricketts DN, Kidd EA. Reproducibility and accuracy of three methods for assessment of demineralization depth of the occlusal surface: an in vitro examination. Caries Res. 1997;31(3):224-31. doi: 10.1159/000262404.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. april 2016
Primær fullføring (Faktiske)
1. november 2016
Studiet fullført (Faktiske)
1. november 2017
Datoer for studieregistrering
Først innsendt
7. april 2016
Først innsendt som oppfylte QC-kriteriene
17. mai 2016
Først lagt ut (Anslag)
20. mai 2016
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
8. november 2017
Siste oppdatering sendt inn som oppfylte QC-kriteriene
6. november 2017
Sist bekreftet
1. november 2017
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- SLM2
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
UBESLUTTE
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