Impact of Two Recall Intervals on Dental Caries Incidence, Anxiety and Quality of Life of Preschool Children
17. april 2019 opdateret af: Gabriela Oliveira Berti, University of Sao Paulo
Impact of Two Recall Intervals Associated to Oral Health Counseling on Dental Caries Incidence, Anxiety and Quality of Life of Preschool Children With Low and Moderate Caries Risk: Randomized Clinical Trial
Objectives: To assess the effectiveness of two recall intervals on dental caries incidence (primary outcome) in preschool children with low and moderate caries risk.
The level of anxiety, oral health related quality of life (OHRQoL), time and cost (secondary outcomes) according to each interval will also be assessed.
Methods: The sample will consist of 224 children between 3-5 years of age, of both genders, with low and moderate caries risk according to the clinical criteria adapted from the Secretary of Health of São Paulo.
Children will be randomly allocated into two study groups: Group 1 (G1) - oral clinical examination + orientation for oral health and diet on the recall of 12 months; and Group 2 (G2) - oral clinical examination + orientation for oral health and diet on the recall of 18 months.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
An examiner calibrated and blinded to the study groups and the secondary outcomes will perform the clinical examinations, which consist of: the gingival bleeding index, dental plaque index, detection of caries and its activity according to the ICDAS (International Caries Detection and Assessment System) and the clinical features of active and inactive caries lesions will be associated with the criteria discribed in ICDAS Commitee manual.
An external dentist will conduct the assessment of the anxiety levels assessed by the Facial Image Scale, the OHRQoL measured by B-ECOHIS (Brazilian Early Childhood Oral Health Impact Scale), the time and costs.
All groups will be followed for a period of 36 months.
All analyzes will be performed with the intention of treatment (ITT) and considering the sensitivity analyzes to assess the differences between the ITT analyzes and the complete cases analyzes.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
224
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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-
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São Paulo, Brasilien, 05508-000
- Dental School of University of São Paulo
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
3 år til 5 år (Barn)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Children between 3-5 years of age, of both genders, with low and moderate caries risk according to the clinical criteria adapted from the Secretary of Health of São Paulo.
- Guardians who have signed the informed consent confirming their participation and their child in research.
Exclusion Criteria:
- Children showing visible dental plaque and gingivitis in baseline.
- Children showing more than 08 active and/or inactive caries cavitated surfaces, and who show fistula and/or dental abscess.
- Special patients.
- Children who received professional application of fluoride in the 6 months prior to the survey.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Andet: Group 1 - Recall Interval of 12 months
Oral clinical conditions: Caries incidence assessment dental anxiety assessment oral health related quality of life assessment time and costs assessment |
Caries incidence assessment dental anxiety assessment oral health related quality of life assessment time and costs assessment
Andre navne:
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Andet: Group 2 - Recall Interval of 18 months
Oral clinical conditions: Caries incidence assessment dental anxiety assessment oral health related quality of life assessment time and costs assessment |
Caries incidence assessment dental anxiety assessment oral health related quality of life assessment time and costs assessment
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Dental caries incidence - Change
Tidsramme: Baseline, 12 months and 18 months
|
Dental caries will be assessed using the ICDAS criteria (Ismail AI, Sohn W, Tellez M, Amaya A, Sen A, Hasson H, et al.
The International Caries Detection and Assessment System (ICDAS): an integrated system for measuring dental caries.
Community Dent Oral Epidemiol 2007; 35: 170-8).
|
Baseline, 12 months and 18 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Level of anxiety - Change
Tidsramme: Baseline, 12 months and 18 months
|
Level of anxiety will be assessed using the Facial Image Scale (Buchanan H, Niven N. Validation of a facial image scale to assess child dental anxiety.
Int J Paediatr Dent 2002;12:47-52).
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Baseline, 12 months and 18 months
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Oral health related quality of life - Change
Tidsramme: Baseline, 12 months and 18 months
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Oral health related quality of life will be assessed using the Brazilian validation of the ECOHIS (Scarpelli AC, Oliveira BH, Tesch FC, Leão AT, Pordeus IA, Paiva SM.
Psychometric properties of the Brazilian version of the Early Childhood Oral Health Impact Scale (B-ECOHIS).
BMC Oral Health.
2011; 11:19).
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Baseline, 12 months and 18 months
|
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Time
Tidsramme: Baseline, 12 months and 18 months
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The time in minutes, used in the recall interval visits, will be recorded in four categories: time spent on clinical examination including prophylaxis, hygiene and diet orientations, and time spent when the patient miss the recall visit.
The total time will correspond to the sum of these categories.
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Baseline, 12 months and 18 months
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Costs
Tidsramme: Baseline, 12 months and 18 months
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Costs in real (continuous variable) will be recorded in two categories: salary of the dentist and dental assistant paid in public dental services in São Paulo, cost of dental materials/products used in the appointment.
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Baseline, 12 months and 18 months
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studiestol: Marcelo Bönecker, Professor, University of Sao Paulo
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. marts 2015
Primær færdiggørelse (Faktiske)
1. marts 2018
Studieafslutning (Faktiske)
1. marts 2018
Datoer for studieregistrering
Først indsendt
3. september 2014
Først indsendt, der opfyldte QC-kriterier
8. oktober 2014
Først opslået (Skøn)
13. oktober 2014
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
18. april 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
17. april 2019
Sidst verificeret
1. juni 2017
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 7709191
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .