An interventional study of ICCMS in Caries,Dental, sponsored by Federal University of Pelotas. Recruiting at 1 site in Brazil. Open to participants aged 7 Years to 11 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-25.
Sponsored by Federal University of Pelotas · Not applicable, Interventional, and Prevention
Among 82 studies in Dental Caries with a site in Brazil — 5 open to participants now, 6 under way, none of them phase 3. Dental Caries · Brazil.
Among the 82 studies in Dental Caries with a site in Brazil, this one is the 17th largest by planned enrollment of the 79 interventional ones, is one of 6 that started in 2019, is one of 57 with no phase, and was the 64th registered.
1,171 studies on the registry are indexed under Dental Caries; 209 are open to participants now.
This study's planned enrollment of 250 is above the median of 60 across 967 interventional studies indexed under Dental Caries.
Browse Dental Caries studies →5 of the 82 studies in Dental Caries with a site in Brazil are open now, in 2 countries. Each count lists the studies.
Of the 86 Dental Caries studies recruiting now, 18 (21%) set no upper age limit and 66 (77%) stop at 75 or younger; 60 take children under 18; 53 take healthy volunteers.
This study: 7 Years to 11 Years · all sexes · healthy volunteers too.
The full table on the hub →82 studies; the count open now beside each. This study's row is marked.
First in 2001; this study’s year is marked. 6 started in 2019.
Median enrollment 119 across the 79 interventional studies, 200 across the 3 observational. Of the 50 that completed or were terminated, 2 (4%) have results posted.
3 of 82 have an industry lead sponsor. The 10 most frequent:
Federal University of Pelotas is the lead sponsor of 52 studies on the registry; 4 are open to participants now.
Federal University of Pelotas has 3 studies filed under Dental Caries — fewer than ten, so there is no comparison to draw.
1 of the studies in Dental Caries with a site in Brazil that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05965297DMG Dental Material Gesellschaft mbHComparison of Two GIC's in the Restoration of Posterior Class II Lesions in the Primary Dentition | 2027-08 |
Among the 82 studies in Dental Caries with a site in Brazil, from their registry updates:
Nothing recorded among them since 2026-09-25.
The aim of the study was to compare dental caries treatment and follow-up based on an elaborate and individualized assessment of caries risk in children, to a simpler risk assessment strategy by means of a double-blind randomized clinical trial of two years monitoring. Participants will be children from 7 to 11 years old, who pass through the screening of the Children's Clinic of the Faculty of Dentistry of the Federal University of Pelotas and fulfill the inclusion criteria. A randomized, stratified sample of approximately 250 children will be included in the study, one group will be composed of children undergoing dental caries-related treatment and maintenance, guided by an individualized and multivariate risk assessment, and another group of children treated based on dental caries experience alone in the deciduous and / or permanent dentition. Recruitment will begin at the beginning of 2019, and participants will be followed up for 24 months. Parents will respond to an anamnesis, 24-hour dietary recall, food frequency questionnaire, and oral and general health-related quality of life questionnaire, children will undergo a clinical examination to assess caries, according to the International Caries Detection and Assessment System (ICDAS) in its simplified form and evaluation of caries activity. Dental treatments and return intervals will be designated according to the individual risk of the patient detected in the initial approach according to the group. The study evaluations consist of baseline, 12 months and 24 months, data will be transferred to spreadsheets after the different phases of the study. Primary outcomes (number of dental surfaces requiring operative intervention) and secondary outcomes will be analyzed by Student's t test, quality of life and quality of life related to oral health, will be assessed at the beginning of the study and at the end of treatment, and compared between the groups.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Multivariate risk assessment group (ICCMS®): multivariate caries risk assessment based on International Caries Classification and Management System (ICCMS™) guide
Diagnostic Test: ICCMS
Simplified risk assessment group (dental caries experience): simplified caries risk assessment based on dental caries experience (WHO criteria)
Diagnostic Test: ICCMS
Risk caries assessment will consider ICCMS criteria
New caries lesions
Incremental number of dental surfaces with operative treatment needs. This outcome will be assessed by the new caries lesions and / or progression of lesions previously diagnosed / treated and number of treated surfaces which will need restoration replacement, endodontic treatment or extraction after the treatment plan.
Time frame: from baseline (first measurement) to 24months
Quality of life score
Impact on oral health related quality of life measured by a validated questionnaire (CPQ)
Time frame: from baseline (first measurement) to 24months
Plan to share: No
Started Jun 2019 (actual). Primary completion is estimated for Jun 2025, 72 months after the start.
Of 469 non-industry interventional studies with no phase under Dental Caries, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 30. This study's planned 72 months is above that.
Counting every sponsor, half of 502 studies reached it within 15 months; a quarter within 7 and three quarters within 29.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Federal University of Pelotas