Dental CariesNCT03100773
Impact of Atraumatic Restorative Treatment and Oral Health Promotion on Psychological and Salivary Aspects of Children
A study testing Oral health educational strategy and Atraumatic Restorative Treatment in people with Dental Caries, run by University of Campinas, Brazil.
Trial summary
This study evaluated the impact of atraumatic restorative treatment associated with oral health educational strategy on dental anxiety, oral health-related quality of life and salivary biochemical and microbiological characteristics of Brazilian schoolchildren. Read more about this study
- Who is it for?
- Ages 6 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- Oral health educational strategy and Atraumatic Restorative Treatment
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Nov 2015
- 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 6 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- caries-free;
- presence of at least one primary molar with dentin caries lesion (without painful symptoms, mobility and abscess).
Who cannot join
- indication for tooth extraction;
- presence of fistula;
- abscess or spontaneous toothache;
- insufficient tooth structure to support restoration;
- current use of medications that could interfere with the central nervous system;
- inappropriate behavior and/or refusal to participate.
About this study
Official title: Impact of Atraumatic Restorative Treatment Associated With Oral Health Educational Strategy on Dental Anxiety, Oral Health-related Quality of Life and Salivary Biochemical and Microbiological Characteristics of Brazilian Schoolchildren
This study evaluated the impact of atraumatic restorative treatment associated with oral health educational strategy on dental anxiety, oral health-related quality of life and salivary biochemical and microbiological characteristics of Brazilian schoolchildren.
Read the detailed description
Children aged six- to eight years-old, both gender, were selected from public schools of Piracicaba, SP, Brazil, and were divided in three groups: caries-free children (control group, GC), children with at least one primary molar with dentin caries lesion submitted to oral health educational strategy followed by ART (GS+ART), and the other group was directly submitted to ART (GART). Oral hygiene was assessed by the presence of biofilm and gingivitis in buccal surfaces of primary and/or permanent upper incisors. Oral health educational strategy consisted of four consecutive sessions (once a week) about etiological factors of caries (using visual aids), oral hygiene instructions (using models), supervised toothbrushing and explanation of ART (indications and stages). ART was performed using hand instruments for opening and cleaning the cavities and a high-viscosity glass-ionomer for restoration. Dental anxiety was assessed by measuring the cognitive (modified Venham Picture Test, m-VPT), behavioral (modified Venham Anxiety Scale, m-VAS) and physiological (heart rate, HR; salivary cortisol and alpha-amylase, SC and SAA) aspects in the following days and moments: D1 - baseline, a day preceding ART (SC and SAA); D2 - day of treatment, before strategy (m-VPT), before ART (m-VPT, HR, SC, SAA), during the explanation of procedure (HR, m-VAS), at the moment of deepest excavation (HR, m-VAS), at the moment the restoration was applied (HR, m-VAS), after ART (m-VPT, HR, SC, SAA). The following variables were evaluated in three moments: T1 - baseline, T2 - one week after strategy (for both GC and GART) and T3 - one month after the strategy or ART for GC and GART, respectively. Oral health-related quality of life was assessed using Brazilian short version of the Child Perceptions Questionnaire (16-CPQ8-10) with 16 items. Salivary flow rate was estimated by chewing 0.3g of an inert and tasteless material, for approximately 70 cycles/min and spitting all the saliva produced for five minutes into a cooled tube. Salivary pH was determined immediately after collection, using a portable pH-meter. Salivary buffer capacity was performed by adding 1.5 ml of HCl/5 mM to a tube containing 0.5 mL of stimulated saliva. For detection and quantification of S. mutans, the microbial DNA in unstimulated saliva samples was isolated and subjected to quantitative PCR reactions (qPCR).
- Conditions
- Dental Caries
- Being tested
- Oral health educational strategy, Atraumatic Restorative Treatment
- Keywords
- alpha-amylases, child, cortisol, dental anxiety, dental atraumatic restorative treatment, health education, microbiota, oral hygiene, quality of life, saliva
- Medical subject headings
- Dental Caries, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral health educational strategyOther
Oral health educational strategy consisted of four consecutive sessions (once a week) about etiological factors of caries (using visual aids), oral hygiene instructions (using models), supervised toothbrushing and explanation of atraumatic restorative treatment (indications and stages).
Atraumatic Restorative TreatmentProcedure or surgery
Atraumatic Restorative Treatment was performed using hand instruments for opening and cleaning the cavities and a high-viscosity glass-ionomer for restoration.
| Study group | Role | What they receive |
|---|---|---|
| Group control | Experimental | Caries-free children submitted to four consecutive sessions of oral health educational strategy (once a week). Receives: Other: Oral health educational strategy |
| Group of strategy + ART | Experimental | Children with at least one decayed primary molar in dentin submitted to four consecutive sessions of oral health educational strategy (once a week) followed by Atraumatic Restorative Treatment (ART) Receives: Other: Oral health educational strategy; Procedure: Atraumatic Restorative Treatment |
| Group of ART | Experimental | Children with at least one decayed primary molar in dentin submitted to Atraumatic Restorative Treatment (ART) Receives: Procedure: Atraumatic Restorative Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in dental anxiety assessed by measuring the cognitive and behavioral aspects.
The cognitive and behavioral aspects were assessed by modified Venham Picture Test (m-VPT) and modified Venham Anxiety Scale (m-VAS), respectively (scores).
Measured: T1: one day preceding the oral health educational strategies (GS+ART) (m-VPT); T2: during ART procedure (GS+ART and GART) (m-VAS) and immediately after ART (GS+ART and GART) (m-VPT); T3: 10 minutes after ART (GS+ART and GART) (m-VPT).
Change in dental anxiety assessed by measuring the salivary biomarkers.
The hormonal biomarker was assessed by saliva collection for cortisol - sC (in microgram per using commercially available kit (Salimetrics, State College, PA, USA) according to the manufacturer's directions.
Measured: T1: 30 min preceding the ART (GART) and one day preceding OHES (GS+ART); T2: immediately after ART (GS+ART/GART); T3: 10 min after ART (GS+ART/GART).
Change in dental anxiety assessed by measuring the salivary biomarkers.
The enzymatic biomarker was assessed by saliva collection for alpha-amylase - sAA (in international units per milliliter of saliva - U/ml) using commercially available kit (Salimetrics, State College, PA, USA) according to the manufacturer's directions.
Measured: T1: 30 min preceding the ART (GART) and one day preceding OHES (GS+ART); T2: immediately after ART (GS+ART/GART); T3: 10 min after ART (GS+ART/GART).
Change in dental anxiety assessed by measuring the physiological aspect.
The physiological aspect was assessed by heart rate (HR, in beats per minute, bpm) using a digital monitor (S625x, Polar, Finland).
Measured: T1: 30 min preceding the ART (GART) and one day preceding OHES (GS+ART); T2: during ART procedure (GS+ART/GART) and immediately after ART (GS+ART/GART); T3: 10 min after ART (GS+ART/GART).
Change in salivary physicochemical properties.
The physicochemical properties of saliva were measured by flow rate (mL/min), pH and buffer capacity. Salivary stimulated and unstimulated flow rates were estimated as the volume of saliva secreted per min (mL/min). Salivary pH was determined immediately after collection in stimulated saliva, using a portable pH-meter (Orion 3 Star Benchtop, Thermo Electron Corporation, USA). Buffer capacity was performed by adding 1.5 ml of 5 mM HCl to a tube containing 0.5 mL of stimulated saliva and further determination of salivary pH.
Measured: T1: 1 week before oral health strategy (GC and GS+ART); T2: 1 week after oral health strategy (GC and GS+ART); T3: 1 month after oral health strategy (GC) and 1 month after ART (GS+ART).
Change in salivary microbiological properties.
The microbiological characteristics of saliva were measured by total bacteria and S. mutans levels. The detection and quantification of S. mutans and total bacteria, the microbial DNA in unstimulated saliva samples was isolated and subjected to quantitative PCR reactions (qPCR).
Measured: T1: 1 week before oral health strategy (GC and GS+ART); T2: 1 week after oral health strategy (GC and GS+ART); T3: 1 month after oral health strategy (GC) and 1 month after ART (GS+ART).
Secondary outcomes (2)
Change in oral hygiene.
Oral hygiene was assessed by the presence of biofilm and gingivitis in buccal surfaces of primary and/or permanent upper incisors (presence/absence; frequencies) (in scores).
Measured: T1 : 1 week before oral health strategy (GC and GS+ART) and 30 min before ART (GART); T2: 1 week after oral health strategy (GC and GS+ART); T3: 1 week after ART (GART and GS+ART); T4: 1 month after ART (GART and GS+ART).
Change in oral health-related quality of life.
Oral health-related quality of life was assessed using the Brazilian short version of the Child Perceptions Questionnaire (16-CPQ8-10), with 16 items (in scores).
Measured: T1: 1 week before oral health strategy (GC and GS+ART) and 30 min before ART (GART); T2: 1 week after oral health strategy (GC and GS+ART); T3: 1 week after ART (GART and GS+ART); T4: 1 month after ART (GART and GS+ART).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2017
- Study startJan 2015
- Primary completionNov 2015
- Study completionNov 2015
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.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Campinas, Brazil
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Taís de Souza Barbosa, University of Campinas, Brazil
- Investigators
- Taís S Barbosa, PhD, Principal investigator, University of Campinas, Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03100773
- Sponsor's protocol ID
- CJK-2014-ART
- Status last verified
- Mar 2017
- First submitted
- 22 Jan 2016
- Last updated
- 4 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Atraumatic Restorative Treatment Associated With Oral Health Educational Strategy on Dental Anxiety, Oral Health-related Quality of Life and Salivary Biochemical and Microbiological Characteristics of Brazilian Schoolchildren
- ClinicalTrials.gov ID
- NCT03100773
- Acronym / sponsor ID
- CJK-2014-ART
- Conditions
- Dental Caries
- Keywords
- alpha-amylases, child, cortisol, dental anxiety, dental atraumatic restorative treatment, health education, microbiota, oral hygiene
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- University of Campinas, BrazilUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Jan 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 4 Apr 2017 (actual)
- 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.
This study evaluated the impact of atraumatic restorative treatment associated with oral health educational strategy on dental anxiety, oral health-related quality of life and salivary biochemical and microbiological characteristics of Brazilian schoolchildren.
Detailed description
Children aged six- to eight years-old, both gender, were selected from public schools of Piracicaba, SP, Brazil, and were divided in three groups: caries-free children (control group, GC), children with at least one primary molar with dentin caries lesion submitted to oral health educational strategy followed by ART (GS+ART), and the other group was directly submitted to ART (GART). Oral hygiene was assessed by the presence of biofilm and gingivitis in buccal surfaces of primary and/or permanent upper incisors. Oral health educational strategy consisted of four consecutive sessions (once a week) about etiological factors of caries (using visual aids), oral hygiene instructions (using models), supervised toothbrushing and explanation of ART (indications and stages). ART was performed using hand instruments for opening and cleaning the cavities and a high-viscosity glass-ionomer for restoration. Dental anxiety was assessed by measuring the cognitive (modified Venham Picture Test, m-VPT), behavioral (modified Venham Anxiety Scale, m-VAS) and physiological (heart rate, HR; salivary cortisol and alpha-amylase, SC and SAA) aspects in the following days and moments: D1 - baseline, a day preceding ART (SC and SAA); D2 - day of treatment, before strategy (m-VPT), before ART (m-VPT, HR, SC, SAA), during the explanation of procedure (HR, m-VAS), at the moment of deepest excavation (HR, m-VAS), at the moment the restoration was applied (HR, m-VAS), after ART (m-VPT, HR, SC, SAA). The following variables were evaluated in three moments: T1 - baseline, T2 - one week after strategy (for both GC and GART) and T3 - one month after the strategy or ART for GC and GART, respectively. Oral health-related quality of life was assessed using Brazilian short version of the Child Perceptions Questionnaire (16-CPQ8-10) with 16 items. Salivary flow rate was estimated by chewing 0.3g of an inert and tasteless material, for approximately 70 cycles/min and spitting all the saliva produced for five minutes into a cooled tube. Salivary pH was determined immediately after collection, using a portable pH-meter. Salivary buffer capacity was performed by adding 1.5 ml of HCl/5 mM to a tube containing 0.5 mL of stimulated saliva. For detection and quantification of S. mutans, the microbial DNA in unstimulated saliva samples was isolated and subjected to quantitative PCR reactions (qPCR).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group control | Experimental | Other: Oral health educational strategyCaries-free children submitted to four consecutive sessions of oral health educational strategy (once a week). |
| Group of strategy + ART | Experimental | Other: Oral health educational strategy, Procedure: Atraumatic Restorative TreatmentChildren with at least one decayed primary molar in dentin submitted to four consecutive sessions of oral health educational strategy (once a week) followed by Atraumatic Restorative Treatment (ART) |
| Group of ART | Experimental | Procedure: Atraumatic Restorative TreatmentChildren with at least one decayed primary molar in dentin submitted to Atraumatic Restorative Treatment (ART) |
Who may qualify
- Ages
- 6 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- caries-free;
- presence of at least one primary molar with dentin caries lesion (without painful symptoms, mobility and abscess).
Key exclusion criteria (6 listed)
- indication for tooth extraction;
- presence of fistula;
- abscess or spontaneous toothache;
- insufficient tooth structure to support restoration;
- current use of medications that could interfere with the central nervous system;
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 health educational strategyOral health educational strategy consisted of four consecutive sessions (once a week) about etiological factors of caries (using visual aids), oral hygiene instructions (using models), supervised toothbrushing and explanation of atraumatic restorative treatment (indications and stages). | Other | Group control, Group of strategy + ART |
| Atraumatic Restorative TreatmentAtraumatic Restorative Treatment was performed using hand instruments for opening and cleaning the cavities and a high-viscosity glass-ionomer for restoration. | Procedure or surgery | Group of ART, Group of strategy + ART |
Primary outcome
Change in dental anxiety assessed by measuring the cognitive and behavioral aspects.
Time frame: T1: one day preceding the oral health educational strategies (GS+ART) (m-VPT); T2: during ART procedure (GS+ART and GART) (m-VAS) and immediately after ART (GS+ART and GART) (m-VPT); T3: 10 minutes after ART (GS+ART and GART) (m-VPT).
The cognitive and behavioral aspects were assessed by modified Venham Picture Test (m-VPT) and modified Venham Anxiety Scale (m-VAS), respectively (scores).
Change in dental anxiety assessed by measuring the salivary biomarkers.
Time frame: T1: 30 min preceding the ART (GART) and one day preceding OHES (GS+ART); T2: immediately after ART (GS+ART/GART); T3: 10 min after ART (GS+ART/GART).
The hormonal biomarker was assessed by saliva collection for cortisol - sC (in microgram per using commercially available kit (Salimetrics, State College, PA, USA) according to the manufacturer's directions.
Change in dental anxiety assessed by measuring the salivary biomarkers.
Time frame: T1: 30 min preceding the ART (GART) and one day preceding OHES (GS+ART); T2: immediately after ART (GS+ART/GART); T3: 10 min after ART (GS+ART/GART).
The enzymatic biomarker was assessed by saliva collection for alpha-amylase - sAA (in international units per milliliter of saliva - U/ml) using commercially available kit (Salimetrics, State College, PA, USA) according to the manufacturer's directions.
Change in dental anxiety assessed by measuring the physiological aspect.
Time frame: T1: 30 min preceding the ART (GART) and one day preceding OHES (GS+ART); T2: during ART procedure (GS+ART/GART) and immediately after ART (GS+ART/GART); T3: 10 min after ART (GS+ART/GART).
The physiological aspect was assessed by heart rate (HR, in beats per minute, bpm) using a digital monitor (S625x, Polar, Finland).
Change in salivary physicochemical properties.
Time frame: T1: 1 week before oral health strategy (GC and GS+ART); T2: 1 week after oral health strategy (GC and GS+ART); T3: 1 month after oral health strategy (GC) and 1 month after ART (GS+ART).
The physicochemical properties of saliva were measured by flow rate (mL/min), pH and buffer capacity. Salivary stimulated and unstimulated flow rates were estimated as the volume of saliva secreted per min (mL/min). Salivary pH was determined immediately after collection in stimulated saliva, using a portable pH-meter (Orion 3 Star Benchtop, Thermo Electron Corporation, USA). Buffer capacity was performed by adding 1.5 ml of 5 mM HCl to a tube containing 0.5 mL of stimulated saliva and further determination of salivary pH.
Change in salivary microbiological properties.
Time frame: T1: 1 week before oral health strategy (GC and GS+ART); T2: 1 week after oral health strategy (GC and GS+ART); T3: 1 month after oral health strategy (GC) and 1 month after ART (GS+ART).
The microbiological characteristics of saliva were measured by total bacteria and S. mutans levels. The detection and quantification of S. mutans and total bacteria, the microbial DNA in unstimulated saliva samples was isolated and subjected to quantitative PCR reactions (qPCR).
2 secondary outcomes
Change in oral hygiene.
Time frame: T1 : 1 week before oral health strategy (GC and GS+ART) and 30 min before ART (GART); T2: 1 week after oral health strategy (GC and GS+ART); T3: 1 week after ART (GART and GS+ART); T4: 1 month after ART (GART and GS+ART).
Change in oral health-related quality of life.
Time frame: T1: 1 week before oral health strategy (GC and GS+ART) and 30 min before ART (GART); T2: 1 week after oral health strategy (GC and GS+ART); T3: 1 week after ART (GART and GS+ART); T4: 1 month after ART (GART and GS+ART).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2017.
- Individual participant dataSharing planned: Undecided
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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.
Taís S Barbosa, PhD principal investigator
University of Campinas, Brazil
Questions about this trial
What is this clinical trial studying?
A study testing Oral health educational strategy and Atraumatic Restorative Treatment in people with Dental Caries, run by University of Campinas, 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 6 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: finished, as of the sponsor's last update on 4 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in dental anxiety assessed by measuring the cognitive and behavioral aspects. (time frame: T1: one day preceding the oral health educational strategies (GS+ART) (m-VPT); T2: during ART procedure (GS+ART and GART) (m-VAS) and immediately after ART (GS+ART and GART) (m-VPT); T3: 10 minutes after ART (GS+ART and GART) (m-VPT).). The study lists 6 primary outcomes in all. 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 4 Apr 2017.