Dental CariesNCT02537184
Impact of Two Recall Intervals on Dental Caries Incidence and Other Outcomes of Preschool Children
A study testing Oral Clinical conditions in people with Dental Caries and Quality of Life, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Objectives: To assess the beneficial and harmful effects of two recall intervals on caries incidence (primary outcome) in preschool children with high 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. Read more about this study
- Who is it for?
- Ages 3 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries, Quality of Life, Anxiety
- What is being tested?
- Oral Clinical conditions
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2014to Aug 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children between 3-5 years of age, of both genders, with caries high risk according to the clinical criteria adapted from the Secretary of Health of São Paulo and enrolled in public schools.
- Guardians who have signed the informed consent confirming their participation and their child in research.
Who cannot join
- Children showing visible dental plaque and gingivitis in baseline.
- Children showing more than 06 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Dental School of University of São Paulo
São Paulo, São Paulo, 05508-000
About this study
Official title: Impact of Two Recall Intervals Associated to Oral Health Counseling on Dental Caries Incidence, Anxiety and Quality of Life of Preschool Children With High Caries Risk: Randomized Clinical Trial
Objectives: To assess the beneficial and harmful effects of two recall intervals on caries incidence (primary outcome) in preschool children with high 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 high caries risk according to the clinical criteria adapted from the Municipal Health Secretary of São Paulo. Children will be randomly allocated into two study groups: Group 1 (G1) - oral clinical examination + orientation for oral health and diet in return for 4 months; and Group 2 (G2) - oral clinical examination + orientation for oral health and diet in return for 8 months. An examiner calibrated and blinded to the study groups and the secondary outcomes will perform the clinical examinations, which consist of: 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, the time and costs. All groups will be followed for an initial period of 16 months, totaling four follow-up visits for G1 and two follow-up visits to the G2. All analyzes will be performed by intention to treat (ITT) and considering the sensitivity analysis to assess the differences between the ITT analyzes and analyzes of complete cases.
Read the detailed description
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.
- Conditions
- Dental Caries, Quality of Life, Anxiety
- Being tested
- Oral Clinical conditions
- Medical subject headings
- Dental Caries, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Clinical conditionsProcedure or surgery
Also called Caries Incidence, dental anxiety, oral health related quality of life, time and costs
caries incidence assessment dental anxiety assessment
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - Recall Interval of 4 months | Other | Oral clinical conditions:
Only at baseline all childrens will receive 5% sodium FV (Duraphat, Colgate Oral Pharmaceuticals). Caries incidence assessment dental anxiety assessment oral health related quality of life assessment time and costs assessment Procedure/Surgery: Oral clinical conditions Caries incidence assessment dental anxiety assessment oral health related quality of life assessment time and costs assessment Receives: Procedure: Oral Clinical conditions |
| Group 2 - Recall Interval of 8 months | Other | Oral clinical conditions:
Only at baseline all childrens will receive 5% sodium FV (Duraphat, Colgate Oral Pharmaceuticals). Caries incidence assessment dental anxiety assessment oral health related quality of life assessment time and costs assessment Procedure/Surgery: Oral clinical conditions Caries incidence assessment dental anxiety assessment oral health related quality of life assessment time and costs assessment Receives: Procedure: Oral Clinical conditions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dental caries incidence
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).
Measured: Baseline, 4 months and 8 months
Secondary outcomes (4)
Level of anxiety
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)
Measured: Baseline, 4 months and 8 months
Oral health related quality of life
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).
Measured: Baseline, 4 months and 8 months
Time
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.
Measured: Baseline, 4 months and 8 months
Costs
Costs in real (continuous variable) will be recorded in three 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.
Measured: Baseline, 4 months and 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2015 (estimated)
- Study startSep 2014
- Primary completionAug 2016 (estimated)
- Study completionAug 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 224 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thais Cordeschi, University of Sao Paulo
- Investigators
- Marcelo Bonecker, Professor, Study chair, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02537184
- Sponsor's protocol ID
- 2014/17758-6
- Other IDs
- 2014
- Status last verified
- Aug 2015
- First submitted
- 27 Aug 2015
- Last updated
- 3 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Two Recall Intervals Associated to Oral Health Counseling on Dental Caries Incidence, Anxiety and Quality of Life of Preschool Children With High Caries Risk: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02537184
- Acronym / sponsor ID
- 2014/17758-6
- Conditions
- Dental Caries, Quality of Life, Anxiety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 224 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Aug 2016 (estimated)
- First posted
- 1 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objectives: To assess the beneficial and harmful effects of two recall intervals on caries incidence (primary outcome) in preschool children with high 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 high caries risk according to the clinical criteria adapted from the Municipal Health Secretary of São Paulo. Children will be randomly allocated into two study groups: Group 1 (G1) - oral clinical examination + orientation for oral health and diet in return for 4 months; and Group 2 (G2) - oral clinical examination + orientation for oral health and diet in return for 8 months. An examiner calibrated and blinded to the study groups and the secondary outcomes will perform the clinical examinations, which consist of: 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, the time and costs. All groups will be followed for an initial period of 16 months, totaling four follow-up visits for G1 and two follow-up visits to the G2. All analyzes will be performed by intention to treat (ITT) and considering the sensitivity analysis to assess the differences between the ITT analyzes and analyzes of complete cases.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 - Recall Interval of 4 months | Other | Procedure: Oral Clinical conditionsOral clinical conditions: Only at baseline all childrens will receive 5% sodium FV (Duraphat, Colgate Oral Pharmaceuticals). Caries incidence assessment dental anxiety assessment oral health related quality of life assessment time and costs assessment Procedure/Surgery: Oral clinical conditions Caries incidence assessment dental anxiety assessment oral health related quality of life assessment time and costs assessment |
| Group 2 - Recall Interval of 8 months | Other | Procedure: Oral Clinical conditionsOral clinical conditions: Only at baseline all childrens will receive 5% sodium FV (Duraphat, Colgate Oral Pharmaceuticals). Caries incidence assessment dental anxiety assessment oral health related quality of life assessment time and costs assessment Procedure/Surgery: Oral clinical conditions Caries incidence assessment dental anxiety assessment oral health related quality of life assessment time and costs assessment |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children between 3-5 years of age, of both genders, with caries high risk according to the clinical criteria adapted from the Secretary of Health of São Paulo and enrolled in public schools.
- Guardians who have signed the informed consent confirming their participation and their child in research.
Key exclusion criteria (4 listed)
- Children showing visible dental plaque and gingivitis in baseline.
- Children showing more than 06 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral Clinical conditionsAlso: Caries Incidence, dental anxiety, oral health related quality of life, time and costscaries incidence assessment dental anxiety assessment | Procedure or surgery | Group 1 - Recall Interval of 4 months, Group 2 - Recall Interval of 8 months |
Primary outcome
Dental caries incidence
Time frame: Baseline, 4 months and 8 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).
4 secondary outcomes
Level of anxiety
Time frame: Baseline, 4 months and 8 months
Oral health related quality of life
Time frame: Baseline, 4 months and 8 months
Time
Time frame: Baseline, 4 months and 8 months
Costs
Time frame: Baseline, 4 months and 8 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcelo Bonecker, Professor study chair
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral Clinical conditions in people with Dental Caries and Quality of Life, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dental caries incidence (time frame: Baseline, 4 months and 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2015.