Dental CariesNCT02569047
ART and Hall Technique for Management of Occlusal-proximal Caries in Primary Molars
A study testing Atraumatic Restorative Treatment and Hall Technique in people with Dental Caries, run by University of Sao Paulo.
Trial summary
The aim of this, two-arm, parallel group, patient-randomised controlled, superiority trial is to evaluate the survival rate of approximal Atraumatic Restorative Treatment (ART) restorations compared to the Hall Technique (HT) placed in a school setting. Read more about this study
- Who is it for?
- Ages 5 to 10 years
- Conditions the study is for
- Dental Caries
- What is being tested?
- Atraumatic Restorative Treatment and Hall Technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 131 participants
- Where
- No sites listed yet
- Study dates
- Oct 2015to Nov 2018
- 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 5 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children aged between 5 and 10 years
- cooperative behavior
- presenting good health conditions
- whose parents or legal guardians accept and sign the consent form
- with at least one occluso-proximal lesion in primary molar
- only occlusal-proximal surfaces with caries lesions with dentin involvement
Show all 11Show fewer
- cavities accessible to hand instruments used in ART
- absence of fistula or abscess near the selected tooth
- absence of pulp exposure in the selected tooth
- absence of mobility in the selected tooth
- cavity size in the selected tooth not be bigger than 2.0 mm in the mesial-distal and 2.5 in the occlusal-cervical and bucco-lingual directions.
Who cannot join
- children younger than 5 years and older than 10
- non-cooperative behavior
- without good health conditions
- whose parents or legal guardians did not accepted and signed the consent form
- without any occluso-proximal lesion in primary molar
- caries in the selected tooth reaching other surfaces (than occlusal-proximal surface)
Show all 12Show fewer
- occlusal-proximal surface with caries without dentin involvement
- cavities not accessible to hand instruments
- fistula or abscess near the selected tooth
- pulp exposure in the selected tooth
- mobility in the selected tooth
- cavity size bigger than 2.0 mm in the mesial-distal and 2.5 in the occlusal-cervical and - bucco-lingual directions.
About this study
Official title: ART and Hall Technique for the Management of Occlusal-proximal Caries in Primary Molars: A Randomized Clinical Trial
The aim of this, two-arm, parallel group, patient-randomised controlled, superiority trial is to evaluate the survival rate of approximal Atraumatic Restorative Treatment (ART) restorations compared to the Hall Technique (HT) placed in a school setting. The investigators will recruit 120 schoolchildren (5-10 years) with at least one occlusal-proximal carious lesion in primary molar. They will be randomized and treated following best-practice protocols to either receive an ART restoration using the high-viscosity glass ionomer cement (EQUIA Forte, capsules, GC Corp.) or a preformed metal crown placed using the HT (3M ESPE) cemented with glass ionomer luting cement (Fuji I Capsules, GC Corp.). Baseline measures and outcome data (at reviews over a three year period) will be assessed through participant report, clinical examination and parent report/ questionnaires.
Read the detailed description
The selected children will be randomly allocated into 2 groups. The control group will comprise cavities treated by ART, following the protocol proposed by Frencken and Holmgren (1999), while the experimental group will comprise cavities treated by HT, according to the guideline published by Innes and Evans (2011). The allocation of patients in each group will be carried out by a random list generated by a specific computer program. To ensure the allocation concealment, the sequence generated by randomization will be distributed in opaque, sealed envelopes, which will be opened by the operator during the treatment, only after the patient is ready to receive treatment.
Operators will be two undergraduate students in dentistry and one experienced specialist in pediatric dentistry that will be trained on how to prepare and fill the cavities according to the original procedures of ART (Frencken and Holmgren, 1999) and also according to HT (Innes and Evans, 2011). The training will include a lecture about the techniques used in this study, as well as a workshop held in the laboratory for students to train handling and application of treatments to be tested. They will also undergo a week of training with patients, to apply the different techniques before starting the study, the latter phase held at the Faculty of Dentistry, University of São Paulo, under the supervision of an experienced dentist in ART and HT.
Each child will be allocated for one of the operators with the aid of a random list. All treatments will be performed on the school premises, in field conditions without the use of dental chair or other facilities from a clinical environment.
- Conditions
- Dental Caries
- Being tested
- Atraumatic Restorative Treatment, Hall Technique
- Keywords
- Atraumatic Restorative Treatment, Occlusoproximal, Primary Teeth, Glass Ionomer Cements, Hall Technique
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atraumatic Restorative TreatmentProcedure or surgery
Also called Equia Forte
No local anaesthesia will be used. Infected carious tissue will be removed with hand instruments, and the cavities restored with Glass Ionomer Cement (GIC).The cavity will be filled with GIC. After the press-finger technique, the excess of material will be removed.
Hall TechniqueProcedure or surgery
Also called Metal Crowns
It employs the cementation of preformed metal crowns (PMC) without the need of any prior teeth preparation or caries removal. No local anesthesia is used neither tooth preparation.Different sizes of PMCs will be tested until the smallest size that perfectly fit the tooth is achieved. The PMC will be loaded with the dental material glass ionomer cement (GIC) and placed. Child will asked to bite firmly on it, until it is fitted. The excess of GIC will be removed with hand instruments and dental floss.
| Study group | Role | What they receive |
|---|---|---|
| Atraumatic Restorative Treatment | Active comparator | The cavity will be prepared according to the ART (Atraumatic Restorative Treatments) steps and filled with the dental material Glass Ionomer Cement without local anesthesia. Receives: Procedure: Atraumatic Restorative Treatment |
| Hall Technique | Experimental | The cavity will not receive any preparation. A stainless crown will be placed and cemented with the dental material Glass Ionomer Cement without local anesthesia. Receives: Procedure: Hall Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
The restoration survival (changes from baseline up to 36 months)
The treatments will be classified "success" when they present clinical satisfactory aspect, and the failures will be scored as "minor failures" and "major failures" (adapted from Innes et al., 2007). The minor failures will be those in which there is a defect in the restoration / crown, but it does not interfere with the tooth health. The major failures will be considered when there signs or symptoms of irreversible pulp damage, such as dental fistula / abscess, tooth fracture or failures that cannot be repaired .The ART-restorations and HT scored as satisfactory will be considered as "successful", while those presented minor and major failures will be considered as "failure".
Measured: The treatments will be evaluated after 1 week up to 36 months
Secondary outcomes (7)
Child self-reported discomfort
For the assessment of discomfort, the Wong-Baker FACES pain rating scale will be used (Wong; Baker, 1988), which is an ordinal six-point scale ranging from 0 to 5. A score of 0 shows a smiling face, indicating no discomfort, whereas a score of 5 shows a crying and sad face, indicating great discomfort. This method was previously validated for the assessment of pain and discomfort in children (Wong; Baker, 1988; Luffy; Grove, 2003; Novaes et al., 2010)
Measured: Baseline
Perception and concerns related to tooth appearance.
The Child's and Parent's Questionnaire about Teeth Appearance will be applied as interview to children in the school as well as being filled out by their parents / caregivers at home (Furtado et al., 2012).
This instrument has a version for kids and a version for their parents, including questions related to physical, psychological and social order, beyond the perceptions of color change and other aesthetic conditions related to the child´s teeth.
Measured: baseline up to 6 months
Acceptance of children in relation to treatments performed.
The questionnaire for the evaluation of acceptance in relation to treatment performed will be applied as interview to children in the school. The questionnaire for the children contains 6 items and employs a 5-point pictorial Likert scale. The response possibilities were: strongly agree, agree, indifferent, disagree and strongly disagree. The questionnaires were based on questionnaires used by Bell et al. (2010) They were rewritten in order to be useful for both the ART and the HT. The questionnaires will be translated from English to Portuguese by a Brazilian dentist who is fluent in both languages. The first and last question for the children was identical to control the reliability of answering.
Measured: Immediately after treatment (in the same appointment)
Acceptance of parents in relation to treatments performed.
The questionnaire for the evaluation of acceptance in relation to treatment performed will be filled out by their parents / caregivers at home. The questionnaire for the children contains 6 items and employs a 5-point pictorial Likert scale. The response possibilities were: strongly agree, agree, indifferent, disagree and strongly disagree. The questionnaires were based on questionnaires used by Bell et al. (2010) They were rewritten in order to be useful for both the ART and the HT. The questionnaires will be translated from English to Portuguese by a Brazilian dentist who is fluent in both languages. The first and last question for the children was identical to control the reliability of answering.
Measured: Immediately after treatment (in the same appointment)
Occlusal vertical dimension assessment
The distance between the most coronal points of the primary canines at the treatment side will be used as determination of the Occlusal vertical dimension assessment (OVD - van der Zee, van Amerongen, 2011).
The most coronal point of the upper canine will be marked on the lower canine when biting in maximal occlusion using a pencil.
Subsequently the distance between the marked point and the most coronal point of the lower canine will be measured using a digital calliper (GT-DC-02, Globotronics, Meer, BE). If measuring the OVD score on the treatment side is impossible because of tooth loss, the contralateral side will be used to measure the OVD score.
Measured: The measurements will be done before treatment, immediately after treatment (in the same appointment) and at each check-up appointment (1, 2 and 3 weeks and 1, 6, 12, 18, 24, 30 and 36 months)
Cost-effectiveness assessment
The cost of treatments will be calculated then taking into account:
Capital cost: Fixed cost of equipment and instruments such as the cost of autoclave, examination kits; Materials cost or cost of expendable supplies such as gloves, masks, articulating paper, restorative material and PMCs; Labor costs will include salaries of personnel such as a dentist and a dental nurse per day using the maximum levels of the Brazilian Public Health Service salary scales for these professionals in the city treatments will be performed and Time taken to do each procedure of restorative treatments using a stopwatch that will be started when the patient has his/her mouth open and the operator is about to start the restorative intervention and will be stopped when the child stands up from the treatment table.
Measured: Up 36 months
Oral Health Quality of life (OHRQoL) assessment
The perceptions of parents and children regarding the OHRQoL will be evaluated. For that, the Child Perceptions Questionnaire validated for Brazilian children which takes into account the cognitive abilities and lifestyles in an age ranging from 8 to 10 years (CPQ8-10) will be used (Barbosa et al., 2009).
The instrument consists of 14 questions, distributed into four domains (child symptoms, function, psychological, and self-image/social interaction domains) and in a family impact section (oral symptoms, functional limitations, emotional well-being and social well-being).
Measured: Before the treatment and during the 6 months recall
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionNov 2018
- Study completionNov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (48)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- University of Dundee, Academic Centre for Dentistry in Amsterdam
- Responsible party
- Principal investigator, Daniela Prócida Raggio, University of Sao Paulo
- Investigators
- Daniela P Raggio, Professor, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02569047
- Sponsor's protocol ID
- HALLART
- Status last verified
- Aug 2019
- First submitted
- 28 Sep 2015
- Last updated
- 29 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Barbosa TS, Tureli MC, Gaviao MB. Validity and reliability of the Child Perceptions Questionnaires applied in Brazilian children. BMC Oral Health. 2009 May 18;9:13. doi: 10.1186/1472-6831-9-13.
PubMed 19450254Barbosa Tde S, Gaviao MB. Validation of the Parental-Caregiver Perceptions Questionnaire: agreement between parental and child reports. J Public Health Dent. 2015 Fall;75(4):255-64. doi: 10.1111/j.1752-7325.2012.00371.x. Epub 2012 Sep 21.
PubMed 22994794Bell SJ, Morgan AG, Marshman Z, Rodd HD. Child and parental acceptance of preformed metal crowns. Eur Arch Paediatr Dent. 2010 Oct;11(5):218-24. doi: 10.1007/BF03262750.
PubMed 20932394Benderli Y, Ulukapi H, Balkanli O, Kulekci G. In vitro plaque formation on some dental filling materials. J Oral Rehabil. 1997 Jan;24(1):80-3. doi: 10.1046/j.1365-2842.1997.00425.x.
PubMed 9049925Bonifacio CC, Hesse D, Raggio DP, Bonecker M, van Loveren C, van Amerongen WE. The effect of GIC-brand on the survival rate of proximal-ART restorations. Int J Paediatr Dent. 2013 Jul;23(4):251-8. doi: 10.1111/j.1365-263X.2012.01259.x. Epub 2012 Aug 14.
PubMed 22891625Brito CR, Velasco LG, Bonini GA, Imparato JC, Raggio DP. Glass ionomer cement hardness after different materials for surface protection. J Biomed Mater Res A. 2010 Apr;93(1):243-6. doi: 10.1002/jbm.a.32524.
PubMed 19557791Carvalho TS, Ribeiro TR, Bonecker M, Pinheiro EC, Colares V. The atraumatic restorative treatment approach: an "atraumatic" alternative. Med Oral Patol Oral Cir Bucal. 2009 Dec 1;14(12):e668-73.
PubMed 19680186da Mata C, Allen PF, Cronin M, O'Mahony D, McKenna G, Woods N. Cost-effectiveness of ART restorations in elderly adults: a randomized clinical trial. Community Dent Oral Epidemiol. 2014 Feb;42(1):79-87. doi: 10.1111/cdoe.12066. Epub 2013 Aug 19.
PubMed 23952107de Amorim RG, Leal SC, Frencken JE. Survival of atraumatic restorative treatment (ART) sealants and restorations: a meta-analysis. Clin Oral Investig. 2012 Apr;16(2):429-41. doi: 10.1007/s00784-011-0513-3. Epub 2011 Jan 28.
PubMed 21274581Fayle SA. UK National Clinical Guidelines in Paediatric Dentistry. Stainless steel preformed crowns for primary molars. Faculty of Dental Surgery, Royal College of Surgeons. Int J Paediatr Dent. 1999 Dec;9(4):311-4. doi: 10.1046/j.1365-263x.1999.00153.x. No abstract available.
PubMed 10815591Frencken JE, Pilot T, Songpaisan Y, Phantumvanit P. Atraumatic restorative treatment (ART): rationale, technique, and development. J Public Health Dent. 1996;56(3 Spec No):135-40; discussion 161-3. doi: 10.1111/j.1752-7325.1996.tb02423.x.
PubMed 8915958Frencken JE, Van 't Hof MA, Van Amerongen WE, Holmgren CJ. Effectiveness of single-surface ART restorations in the permanent dentition: a meta-analysis. J Dent Res. 2004 Feb;83(2):120-3. doi: 10.1177/154405910408300207.
PubMed 14742648Frencken JE, Leal SC, Navarro MF. Twenty-five-year atraumatic restorative treatment (ART) approach: a comprehensive overview. Clin Oral Investig. 2012 Oct;16(5):1337-46. doi: 10.1007/s00784-012-0783-4. Epub 2012 Jul 24.
PubMed 22824915Gaskin EB, Harless JD, Wefel JS, Guzman-Armstrong S, Armstrong SR, Vargas MA, Hernandez MM, Qian F. Fluorescence changes in remineralized and nonremineralized enamel adjacent to glass ionomer ART restorations: an in vitro study. J Dent Child (Chic). 2007 Sep-Dec;74(3):215-20.
PubMed 18482517Hesse D, Bonifacio CC, Mendes FM, Braga MM, Imparato JC, Raggio DP. Sealing versus partial caries removal in primary molars: a randomized clinical trial. BMC Oral Health. 2014 May 28;14:58. doi: 10.1186/1472-6831-14-58.
PubMed 24884684
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ART and Hall Technique for the Management of Occlusal-proximal Caries in Primary Molars: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02569047
- Acronym / sponsor ID
- HALLART
- Conditions
- Dental Caries
- Keywords
- Atraumatic Restorative Treatment, Occlusoproximal, Primary Teeth, Glass Ionomer Cements, Hall Technique
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- University of Dundee, Academic Centre for Dentistry in Amsterdam
- Study start
- Oct 2015 (actual)
- Primary completion
- Nov 2018 (actual)
- Study completion
- Nov 2018 (actual)
- First posted
- 6 Oct 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.
The aim of this, two-arm, parallel group, patient-randomised controlled, superiority trial is to evaluate the survival rate of approximal Atraumatic Restorative Treatment (ART) restorations compared to the Hall Technique (HT) placed in a school setting. The investigators will recruit 120 schoolchildren (5-10 years) with at least one occlusal-proximal carious lesion in primary molar. They will be randomized and treated following best-practice protocols to either receive an ART restoration using the high-viscosity glass ionomer cement (EQUIA Forte, capsules, GC Corp.) or a preformed metal crown placed using the HT (3M ESPE) cemented with glass ionomer luting cement (Fuji I Capsules, GC Corp.). Baseline measures and outcome data (at reviews over a three year period) will be assessed through participant report, clinical examination and parent report/ questionnaires.
Detailed description
The selected children will be randomly allocated into 2 groups. The control group will comprise cavities treated by ART, following the protocol proposed by Frencken and Holmgren (1999), while the experimental group will comprise cavities treated by HT, according to the guideline published by Innes and Evans (2011). The allocation of patients in each group will be carried out by a random list generated by a specific computer program. To ensure the allocation concealment, the sequence generated by randomization will be distributed in opaque, sealed envelopes, which will be opened by the operator during the treatment, only after the patient is ready to receive treatment.
Operators will be two undergraduate students in dentistry and one experienced specialist in pediatric dentistry that will be trained on how to prepare and fill the cavities according to the original procedures of ART (Frencken and Holmgren, 1999) and also according to HT (Innes and Evans, 2011). The training will include a lecture about the techniques used in this study, as well as a workshop held in the laboratory for students to train handling and application of treatments to be tested. They will also undergo a week of training with patients, to apply the different techniques before starting the study, the latter phase held at the Faculty of Dentistry, University of São Paulo, under the supervision of an experienced dentist in ART and HT.
Each child will be allocated for one of the operators with the aid of a random list. All treatments will be performed on the school premises, in field conditions without the use of dental chair or other facilities from a clinical environment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atraumatic Restorative Treatment | Active comparator | Procedure: Atraumatic Restorative TreatmentThe cavity will be prepared according to the ART (Atraumatic Restorative Treatments) steps and filled with the dental material Glass Ionomer Cement without local anesthesia. |
| Hall Technique | Experimental | Procedure: Hall TechniqueThe cavity will not receive any preparation. A stainless crown will be placed and cemented with the dental material Glass Ionomer Cement without local anesthesia. |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- children aged between 5 and 10 years
- cooperative behavior
- presenting good health conditions
- whose parents or legal guardians accept and sign the consent form
- with at least one occluso-proximal lesion in primary molar
Key exclusion criteria (12 listed)
- children younger than 5 years and older than 10
- non-cooperative behavior
- without good health conditions
- whose parents or legal guardians did not accepted and signed the consent form
- without any occluso-proximal lesion in primary molar
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 |
|---|---|---|
| Atraumatic Restorative TreatmentAlso: Equia ForteNo local anaesthesia will be used. Infected carious tissue will be removed with hand instruments, and the cavities restored with Glass Ionomer Cement (GIC).The cavity will be filled with GIC. After the press-finger technique, the excess of material will be removed. | Procedure or surgery | Atraumatic Restorative Treatment |
| Hall TechniqueAlso: Metal CrownsIt employs the cementation of preformed metal crowns (PMC) without the need of any prior teeth preparation or caries removal. No local anesthesia is used neither tooth preparation.Different sizes of PMCs will be tested until the smallest size that perfectly fit the tooth is achieved. The PMC will be loaded with the dental material glass ionomer cement (GIC) and placed. Child will asked to bite firmly on it, until it is fitted. The excess of GIC will be removed with hand instruments and dental floss. | Procedure or surgery | Hall Technique |
Primary outcome
The restoration survival (changes from baseline up to 36 months)
Time frame: The treatments will be evaluated after 1 week up to 36 months
The treatments will be classified "success" when they present clinical satisfactory aspect, and the failures will be scored as "minor failures" and "major failures" (adapted from Innes et al., 2007). The minor failures will be those in which there is a defect in the restoration / crown, but it does not interfere with the tooth health. The major failures will be considered when there signs or symptoms of irreversible pulp damage, such as dental fistula / abscess, tooth fracture or failures that cannot be repaired .The ART-restorations and HT scored as satisfactory will be considered as "successful", while those presented minor and major failures will be considered as "failure".
7 secondary outcomes
Child self-reported discomfort
Time frame: Baseline
Perception and concerns related to tooth appearance.
Time frame: baseline up to 6 months
Acceptance of children in relation to treatments performed.
Time frame: Immediately after treatment (in the same appointment)
Acceptance of parents in relation to treatments performed.
Time frame: Immediately after treatment (in the same appointment)
Occlusal vertical dimension assessment
Time frame: The measurements will be done before treatment, immediately after treatment (in the same appointment) and at each check-up appointment (1, 2 and 3 weeks and 1, 6, 12, 18, 24, 30 and 36 months)
Cost-effectiveness assessment
Time frame: Up 36 months
Oral Health Quality of life (OHRQoL) assessment
Time frame: Before the treatment and during the 6 months recall
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 29 Aug 2019.
- Background: PubMed 19450254Barbosa TS, Tureli MC, Gaviao MB. Validity and reliability of the Child Perceptions Questionnaires applied in Brazilian children. BMC Oral Health. 2009 May 18;9:13. doi: 10.1186/1472-6831-9-13.
- Background: PubMed 22994794Barbosa Tde S, Gaviao MB. Validation of the Parental-Caregiver Perceptions Questionnaire: agreement between parental and child reports. J Public Health Dent. 2015 Fall;75(4):255-64. doi: 10.1111/j.1752-7325.2012.00371.x. Epub 2012 Sep 21.
- Background: PubMed 20932394Bell SJ, Morgan AG, Marshman Z, Rodd HD. Child and parental acceptance of preformed metal crowns. Eur Arch Paediatr Dent. 2010 Oct;11(5):218-24. doi: 10.1007/BF03262750.
- Background: PubMed 9049925Benderli Y, Ulukapi H, Balkanli O, Kulekci G. In vitro plaque formation on some dental filling materials. J Oral Rehabil. 1997 Jan;24(1):80-3. doi: 10.1046/j.1365-2842.1997.00425.x.
- Background: PubMed 22891625Bonifacio CC, Hesse D, Raggio DP, Bonecker M, van Loveren C, van Amerongen WE. The effect of GIC-brand on the survival rate of proximal-ART restorations. Int J Paediatr Dent. 2013 Jul;23(4):251-8. doi: 10.1111/j.1365-263X.2012.01259.x. Epub 2012 Aug 14.
- Background: PubMed 19557791Brito CR, Velasco LG, Bonini GA, Imparato JC, Raggio DP. Glass ionomer cement hardness after different materials for surface protection. J Biomed Mater Res A. 2010 Apr;93(1):243-6. doi: 10.1002/jbm.a.32524.
- Background: PubMed 19680186Carvalho TS, Ribeiro TR, Bonecker M, Pinheiro EC, Colares V. The atraumatic restorative treatment approach: an "atraumatic" alternative. Med Oral Patol Oral Cir Bucal. 2009 Dec 1;14(12):e668-73.
- Background: PubMed 23952107da Mata C, Allen PF, Cronin M, O'Mahony D, McKenna G, Woods N. Cost-effectiveness of ART restorations in elderly adults: a randomized clinical trial. Community Dent Oral Epidemiol. 2014 Feb;42(1):79-87. doi: 10.1111/cdoe.12066. Epub 2013 Aug 19.
- Background: PubMed 21274581de Amorim RG, Leal SC, Frencken JE. Survival of atraumatic restorative treatment (ART) sealants and restorations: a meta-analysis. Clin Oral Investig. 2012 Apr;16(2):429-41. doi: 10.1007/s00784-011-0513-3. Epub 2011 Jan 28.
- Background: PubMed 10815591Fayle SA. UK National Clinical Guidelines in Paediatric Dentistry. Stainless steel preformed crowns for primary molars. Faculty of Dental Surgery, Royal College of Surgeons. Int J Paediatr Dent. 1999 Dec;9(4):311-4. doi: 10.1046/j.1365-263x.1999.00153.x. No abstract available.
- Background: PubMed 8915958Frencken JE, Pilot T, Songpaisan Y, Phantumvanit P. Atraumatic restorative treatment (ART): rationale, technique, and development. J Public Health Dent. 1996;56(3 Spec No):135-40; discussion 161-3. doi: 10.1111/j.1752-7325.1996.tb02423.x.
- Background: PubMed 14742648Frencken JE, Van 't Hof MA, Van Amerongen WE, Holmgren CJ. Effectiveness of single-surface ART restorations in the permanent dentition: a meta-analysis. J Dent Res. 2004 Feb;83(2):120-3. doi: 10.1177/154405910408300207.
- Individual participant dataSharing planned: No
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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.
Daniela P Raggio, Professor principal investigator
University of Sao Paulo
Questions about this trial
What is this clinical trial studying?
A study testing Atraumatic Restorative Treatment and Hall Technique in people with Dental Caries, 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 11 inclusion and 12 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 29 Aug 2019. 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?
The restoration survival (changes from baseline up to 36 months) (time frame: The treatments will be evaluated after 1 week up to 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02569047, which also lists 48 linked publications.
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 29 Aug 2019.