Effectiveness of Atraumatic Restorative Treatment Using Glass Ionomer Cement of Different Costs (SLM1797)
6 november 2017 uppdaterad 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.
Studieöversikt
Studietyp
Interventionell
Inskrivning (Faktisk)
574
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Sao Paulo
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Campinas, Sao Paulo, Brasilien, 13045755
- Faculty Sao Leopoldo Mandic
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
4 år till 9 år (Barn)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / 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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Experimentell: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Restoration survival
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Cost-effectiveness
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Huvudutredare: Jose Carlos P Imparato, PhD, Faculty Sao Leopoldo Mandic
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 april 2016
Primärt slutförande (Faktisk)
1 november 2016
Avslutad studie (Faktisk)
1 november 2017
Studieregistreringsdatum
Först inskickad
7 april 2016
Först inskickad som uppfyllde QC-kriterierna
17 maj 2016
Första postat (Uppskatta)
20 maj 2016
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
8 november 2017
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
6 november 2017
Senast verifierad
1 november 2017
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- SLM2
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