Caries, DentalNCT03667768
Atraumatic Restorative Treatment Sealants in First Permanent Molars
A study testing Glass ionomer sealant and Non-sealant (toothbrushing) in people with Caries, Dental, run by University of Sao Paulo.
Trial summary
The aim of this bi-center study was to evaluate the retention and caries-preventive effect of Atraumatioc Restorative Treatment (ART) sealants, using two glass ionomer cement (GIC) versus non-sealant on first permanent molars of schoolchildren. Read more about this study
- Who is it for?
- Ages 6 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Caries, Dental
- What is being tested?
- Glass ionomer sealant and Non-sealant (toothbrushing)
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 437 participants
- Where
- No sites listed yet
- Study dates
- Mar 2010to Jun 2013
- 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
- patients presenting the four first permanent molars without gingival tissue covering the occlusal surface and without clinically detectable dentine caries lesion, assessed as scores 0, 1 and 2 of ICDAS criteria [Ismail AI, Sohn W, Tellez M, et al (2007) The International Caries Detection and Assessment System (ICDAS): An integrated system for measuring dental caries: Methods. Community Dent Oral Epidemiol 35:170-178 ].
Who cannot join
- patients presenting any physical and/or medical health issues and having non-cooperative behavior.
About this study
Official title: Atraumatic Restorative Treatment Sealants in First Permanent Molars: a Bi-center Split-mouth Clinical Trial
The aim of this bi-center study was to evaluate the retention and caries-preventive effect of Atraumatioc Restorative Treatment (ART) sealants, using two glass ionomer cement (GIC) versus non-sealant on first permanent molars of schoolchildren. The null hypothesis is that there is no difference in the retention rates of the two GIC, as well as in caries prevention between sealants application and non-sealant. Four hundred and thirty-seven 6-to-8-year-old schoolchildren were selected in two cities in Brazil. They were randomly divided into two groups, according to the GIC used (Fuji IX or Maxxion). All children had their four first permanent molars included in the research and two molars were sealed with a GIC, while the other two molars remained unsealed. Clinical evaluations were performed up to 36 months by one independent examiner at each city.
- Conditions
- Caries, Dental
- Being tested
- Glass ionomer sealant, Non-sealant (toothbrushing)
- Keywords
- Dentition, Permanent, Glass Ionomer Cements
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glass ionomer sealantProcedure or surgery
Non-sealant (toothbrushing)Behavioural
| Study group | Role | What they receive |
|---|---|---|
| Glass ionomer sealant | Experimental | Two hand-mixed glass ionomer cements (GICs) available in the dental market were used, and they were mixed according to the manufacturer's instructions (powder/liquid ratio 1:1). The molars were cleaned with a toothbrush and wet cotton wool pellets. Isolation was performed with cotton wool rolls and the occlusal surface was conditioned with GIC liquid (20s), rinsed with wet cotton wool pellets and dried with dry cotton wool pellets. GIC was placed on the occlusal surface and pressed into the pits and fissures using the press-finger technique. The excess of material was removed and the occlusion checked and adjusted. Sealant was protected with a new layer of petroleum jelly and the children were instructed not to eat for at least one hour. Children received instructions on how to brush their teeth (1,000-ppm fluoridated dentifrice), as well as advices regarding diet and information about dental caries was given by a dental assistant and those instructions were repeated every 6 months. Receives: Procedure: Glass ionomer sealant |
| Non-sealant (toothbrushing) | Other | No sealant was performed. Children received instructions on how to brush their teeth (1,000-ppm fluoridated dentifrice), as well as advices regarding diet and information about dental caries was given by a dental assistant and those instructions were repeated every 6 months. Receives: Behavioral: Non-sealant (toothbrushing) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in glass ionomer selants retention
The sealants retention was evaluated clinically using the criteria: 0) fully present sealant; 1) partially present sealant and 2) absent sealant [Oba AA, Dülgergil T, Sönmez IŞ, Doǧan S (2009) Comparison of Caries Prevention With Glass Ionomer and Composite Resin Fissure Sealants. J Formos Med Assoc 108:844-848]. Scores 0 and 1 were considered "success," whereas score 2 was considered "failure."
Measured: 3, 6, 12, 18, 24 and 36 months
Secondary outcomes (2)
Changes in caries status of first permanent molars
The examiners evaluated the presence of caries according to ICDAS [Ismail AI, Sohn W, Tellez M, et al (2007) The International Caries Detection and Assessment System (ICDAS): An integrated system for measuring dental caries: Methods. Community Dent Oral Epidemiol 35:170-178] and caries activity according to Nyvad criteria [Nyvad B, Machiulskiene V, Baelum V (1999) Reliability of a New Caries Diagnostic System Differentiating between Active and Inactive Caries Lesions. Caries Res 33:252-260].
ICDAS codes 0 to 4 indicated success, while codes 5 and 6 were considered failures.
Measured: 3, 6, 12, 18, 24 and 36 months
Comparison between the development of caries in dentine(measured using ICDAS score system) of first permanent molars between the two cities
The examiners evaluated the presence of caries according to ICDAS [Ismail AI, Sohn W, Tellez M, et al (2007) The International Caries Detection and Assessment System (ICDAS): An integrated system for measuring dental caries: Methods. Community Dent Oral Epidemiol 35:170-178] and caries activity according to Nyvad criteria [Nyvad B, Machiulskiene V, Baelum V (1999) Reliability of a New Caries Diagnostic System Differentiating between Active and Inactive Caries Lesions. Caries Res 33:252-260]. The comparison between the 2 cities was performed in order to verify if demographic/ population characteristics could interfere in the treatments. ICDAS codes 0 to 4 indicated success, while codes 5 and 6 were considered failures.
Measured: 3, 6, 12, 18, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2018
- Study startMar 2010
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caries, DentalStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Split-mouth design
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 437 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Academic Centre for Dentistry in Amsterdam, Universidade Federal de Pernambuco
- Responsible party
- Principal investigator, Daniela Hesse, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03667768
- Sponsor's protocol ID
- USP-SaoPaulo
- Status last verified
- Nov 2018
- First submitted
- 21 Aug 2018
- Last updated
- 9 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atraumatic Restorative Treatment Sealants in First Permanent Molars: a Bi-center Split-mouth Clinical Trial
- ClinicalTrials.gov ID
- NCT03667768
- Acronym / sponsor ID
- USP-SaoPaulo
- Conditions
- Caries, Dental
- Keywords
- Dentition, Permanent, Glass Ionomer Cements
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 437 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Academic Centre for Dentistry in Amsterdam, Universidade Federal de Pernambuco
- Study start
- Mar 2010
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 12 Sep 2018 (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.
The aim of this bi-center study was to evaluate the retention and caries-preventive effect of Atraumatioc Restorative Treatment (ART) sealants, using two glass ionomer cement (GIC) versus non-sealant on first permanent molars of schoolchildren. The null hypothesis is that there is no difference in the retention rates of the two GIC, as well as in caries prevention between sealants application and non-sealant. Four hundred and thirty-seven 6-to-8-year-old schoolchildren were selected in two cities in Brazil. They were randomly divided into two groups, according to the GIC used (Fuji IX or Maxxion). All children had their four first permanent molars included in the research and two molars were sealed with a GIC, while the other two molars remained unsealed. Clinical evaluations were performed up to 36 months by one independent examiner at each city.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Split-mouth design
| Arm | Type | Receives |
|---|---|---|
| Glass ionomer sealant | Experimental | Procedure: Glass ionomer sealantTwo hand-mixed glass ionomer cements (GICs) available in the dental market were used, and they were mixed according to the manufacturer's instructions (powder/liquid ratio 1:1). The molars were cleaned with a toothbrush and wet cotton wool pellets. Isolation was performed with cotton wool rolls and the occlusal surface was conditioned with GIC liquid (20s), rinsed with wet cotton wool pellets and dried with dry cotton wool pellets. GIC was placed on the occlusal surface and pressed into the pits and fissures using the press-finger technique. The excess of material was removed and the occlusion checked and adjusted. Sealant was protected with a new layer of petroleum jelly and the children were instructed not to eat for at least one hour. Children received instructions on how to brush their teeth (1,000-ppm fluoridated dentifrice), as well as advices regarding diet and information about dental caries was given by a dental assistant and those instructions were repeated every 6 months. |
| Non-sealant (toothbrushing) | Other | Behavioral: Non-sealant (toothbrushing)No sealant was performed. Children received instructions on how to brush their teeth (1,000-ppm fluoridated dentifrice), as well as advices regarding diet and information about dental caries was given by a dental assistant and those instructions were repeated every 6 months. |
Who may qualify
- Ages
- 6 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- patients presenting the four first permanent molars without gingival tissue covering the occlusal surface and without clinically detectable dentine caries lesion, assessed as scores 0, 1 and 2 of ICDAS criteria [Ismail AI, Sohn W, Tellez M, et al (2007) The International Caries Detection and Assessment System (ICDAS): An integrated system for measuring dental caries: Methods. Community Dent Oral Epidemiol 35:170-178 ].
Key exclusion criteria (1 listed)
- patients presenting any physical and/or medical health issues and having non-cooperative behavior.
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 |
|---|---|---|
| Glass ionomer sealant | Procedure or surgery | Glass ionomer sealant |
| Non-sealant (toothbrushing) | Behavioural | Non-sealant (toothbrushing) |
Primary outcome
Changes in glass ionomer selants retention
Time frame: 3, 6, 12, 18, 24 and 36 months
The sealants retention was evaluated clinically using the criteria: 0) fully present sealant; 1) partially present sealant and 2) absent sealant [Oba AA, Dülgergil T, Sönmez IŞ, Doǧan S (2009) Comparison of Caries Prevention With Glass Ionomer and Composite Resin Fissure Sealants. J Formos Med Assoc 108:844-848]. Scores 0 and 1 were considered "success," whereas score 2 was considered "failure."
2 secondary outcomes
Changes in caries status of first permanent molars
Time frame: 3, 6, 12, 18, 24 and 36 months
Comparison between the development of caries in dentine(measured using ICDAS score system) of first permanent molars between the two cities
Time frame: 3, 6, 12, 18, 24 months
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 9 Nov 2018.
- Individual participant dataSharing planned: No
Related trials for Caries, Dental
Active, not recruiting
Clinical Evaluation of a New Dual-cure Universal Adhesive
Class I Dental Restorations, Class II Dental Restorations
Not yet recruiting
Safety of Intraosseous Anaesthesia in Children With Haemophilia
Haemophilia A, Haemophilia B
Not yet recruiting
Clinical and Radiographic Evaluation of Silver Diamine Fluoride Versus Light-Cured Silver Diamine Fluoride in Carious Primary Molars
Dental Caries
Not yet recruiting
Clinical Performance of CAD/CAM Hard Hybrid Ceramic Inlays Versus Resin Composite Inlays in Vital Molars With Extensive Occluso-Proximal Cavities
Dental Caries, Cavity, Dental
Not yet recruiting
Effect of Xylitol- Versus Erythritol-Sweetened Mints on Plaque ATP-Bioluminescence Readings
Dental Caries, Dental Plaque
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Glass ionomer sealant and Non-sealant (toothbrushing) in people with Caries, Dental, run by University of Sao Paulo.
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 1 inclusion and 1 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 9 Nov 2018. 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?
Changes in glass ionomer selants retention (time frame: 3, 6, 12, 18, 24 and 36 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 9 Nov 2018.