Dental CariesSLM2078NCT02782390
Efficacy of Hall Technique in Atypical Lesions on Primary Teeth
A study testing Dental Restoration with Stainless Crown and Dental Restoration with Composite Resin in people with Dental Caries, run by Faculty Sao Leopoldo Mandic Campinas at 1 site in Brazil.
Trial summary
Atypical carious cavities could be defined as carious lesions in more than 2 surfaces of the same tooth. Dental practitioners have shown difficulties related to material's maintenance in such type of cavities and therefore, several treatment options have been used. Read more about this study
- Who is it for?
- Ages 4 to 9 years
- Conditions the study is for
- Dental Caries
- What is being tested?
- Dental Restoration with Stainless Crown and Dental Restoration with Composite Resin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 364 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2016to Dec 2017
- 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 4 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children must have at least one molar with atypical caries lesion (involving more than two surfaces);
- parents or legal guardians accept and sign the informed consent form.
Who cannot join
- children with special needs and/or systematic diseases with oral impairment;
- teeth with spontaneous painful symptoms or necrotized and teeth presenting restorations, sealants, developmental enamel defects, pulp exposure or other signs related to endodontic treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Hall Technique in Atypical Lesions on Primary Teeth: Randomized Clinical Trial
Atypical carious cavities could be defined as carious lesions in more than 2 surfaces of the same tooth. Dental practitioners have shown difficulties related to material's maintenance in such type of cavities and therefore, several treatment options have been used. However, most of them have shown a great failure percentage. A randomized clinical trial will be developed with the objective of assessing the Hall technique in comparison with the composite resin incremental technique in 364 primary molars' atypical carious lesions of children between 4 and 9 years old. Initially, two previously calibrated examiners will perform caries diagnosis by means of visual assessment and intraoral examination. Selected teeth will be randomly allocated into two groups. Teeth in the first group will be submitted to prefabricated stainless steel crowns treatment (Hall technique); and the other, to composite resin incremental technique, which will be always placed under rubber dam isolation. Lesions' clinical and radiographic follow-up will be conducted after 6 and 12 months.
Treatment's efficacy will be assessed by means of four main outcomes:
Read more
- Longevity, marginal adaptation, possible modification in patients' vertical dimension, and caries lesion progression;
- Patient-focused criteria (satisfaction, discomfort and quality of life impact);
- cost-efficacy; and
- Treatment-related parents', children' and operators' perception.
Other variables could be further analysed as secondary outcomes, such as techniques performing time among operators, impact of the socio-economic characteristics on restorations' longevity, and restorations' type impact on the antagonist tooth. Comparisons between groups will be addressed using the Kaplan-Meier survival test as well as Long-Rank test. Cox Regression will be used to enable the assessment of other variables' influence in the results. Significance value of 5% will be adopted for all analysis.
- Conditions
- Dental Caries
- Being tested
- Dental Restoration with Stainless Crown, Dental Restoration with Composite Resin
- Keywords
- Stainless dental crown, Composite Resin, Primary teeth
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental Restoration with Stainless CrownOther
Lesions allocated to this group will be treated with stainless dental crowns according to the Hall Technique protocol (Evans \& Innes, 2010).
Dental Restoration with Composite ResinOther
Surfaces allocated to this group will be treated with composite resin (Z250, 3M ESPE, USA) according to the manufacturer's instructions.
Initially, local anesthesia and rubber dam adaptation will be performed. Then, 37% phosphoric acid will be applied on the surface for 15 seconds, followed by spray of water/air for at least 15 seconds. Then, the adhesive system (Single Bond, 3M ESPE, USA) will be applied and light cured according to the manufacturer's instructions. Finally, composite resin (Z250, 3M ESPE, USA) will be applied and light cured according to the manufacturer's instructions.
| Study group | Role | What they receive |
|---|---|---|
| Hall Technique | Experimental | single placement of stainless dental crowns on atypical cavities Receives: Other: Dental Restoration with Stainless Crown |
| Composite Resin | Active comparator | single placement of composite resin on atypical cavities Receives: Other: Dental Restoration with Composite Resin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical longevity of restoration
The clinical evaluation will be performed by the non-blinded examiners. The examiner will use the criteria proposed by Innes et al. (2007) for both interventions.
Measured: Change from baseline until 6 and 12 months
Secondary outcomes (16)
Change in patient's vertical dimension
The patient's vertical dimension will be measured with a probe (Williams 14, Hu-Friedy Mfg. Co., United Kingdom) according to the protocol described by van der Zee \& van Amerongen (2010).
Measured: Baseline, 30 days, 6 and 12 months
Antagonist's level of intrusion
The crown of the antagonist tooth to the treated tooth will be measured with a calliper and a ruler in cervico-occlusal direction (starting on the concave region of the gingival margin up to the center of the occlusal edge), as proposed by Miraglia et al. (2002) and Magalhaes et al. (2011).
Measured: Baseline, 6 and 12 months
Treatments' cost-efficacy
The costs of each treatment procedure will be calculated and compared with thresholds values for intervention cost-effectiveness by region, determined by World Health Organization (http://www.who.int/choice/costs/CER_levels/en/).
Measured: Through study completion (12 months)
Clinical caries lesion progression
Clinical examination will be performed by a blinded examiner at baseline, 6 months and 12 months after the treatment. These exams will be performed in accordance with Innes et al. (2007).
Measured: Baseline, 6 and 12 months
Impact on children's quality of life (4-5 years old)
The oral health related to quality of life will be measured using the validated questionnaire "Early Childhood Oral Health Impact Scale" (ECOHIS) (Tesch et al., 2008) with 4-5 years old children. It will be applied immediately before the procedure and on 6 months follow-up.
Measured: Baseline and 6 months
Impact on children's quality of life (6-9 years old)
The oral health related to quality of life will be measured using the validated questionnaire "Child Perceptions Questionnaire" (CPQ) with 6-9 years old children (Martins et al., 2009). It will be applied immediately before the procedure and on 6 months follow-up.
Measured: Baseline and 6 months
Children's perceptions about the treatment
Children's perceptions about the treatment performed will be evaluated using the validated questionnaire "Child's and Parent's Questionnaire About Teeth Appearance" (Furtado et al., 2012). This questionnaire will be applied immediately before the procedure and on 6 and 12 months follow-up.
Measured: Baseline, 6 and 12 months
Children's satisfaction with the treatment
The patients' satisfaction about the treatment performed will be evaluated using a scale, as performed by Mattos-Silveira et al. (2014). This scale will be applied immediately after the procedure and on 6 months follow-up.
Measured: Baseline and 6 months
Children self-reported discomfort
The discomfort of each treatment will be evaluated using the facial scale of Wong-Baker (Wong, Baker, 1998). The patient will be asked to choose the face that is more similar to how she/he felt during the treatment.This answer should be given solely by the child, which means no parental or professional interferences.
Measured: Baseline
Marginal adaptation of the stainless steel crowns
This outcome will be evaluated only with the patients randomized to the Hall Technique. The clinician will evaluate the marginal adaptation according to the criteria described by Sharaf \& Farsi (2004).
Measured: Baseline, 6 and 12 months
Radiographical caries lesion progression
Radiographical examination will be performed by a blinded examiner at baseline, 6 months and 12 months after the treatment. These exams will be performed in accordance with Innes et al. (2007).
Measured: Baseline, 6 and 12 months
Biofilm retention of the stainless steel crowns
This outcome will be evaluated only with the patients randomized to the Hall Technique. The clinician will evaluate biofilm retention according to the indice proposed by Silness \& Loe (1964), adopted to the primary dentition.
Measured: Baseline, 6 and 12 months
Caregivers' perceptions about the treatment
Caregivers' perceptions about the treatment performed will be evaluated using the validated questionnaire "Child's and Parent's Questionnaire About Teeth Appearance" (Furtado et al., 2012). This questionnaire will be applied immediately before the procedure and on 6 and 12 months follow-up.
Measured: Baseline, 6 and 12 months
Clinicians' perceptions about the treatment
Clinicians' perceptions about the treatment performed will be evaluated using the validated questionnaire "Child's and Parent's Questionnaire About Teeth Appearance" (Furtado et al., 2012). This questionnaire will be applied immediately before the procedure and on 6 and 12 months follow-up.
Measured: Baseline, 6 and 12 months
Caregivers' satisfaction with the treatment
The caregivers' satisfaction about the treatment performed will be evaluated using a scale, as performed by Mattos-Silveira et al. (2014). This scale will be applied immediately after the procedure and on 6 months follow-up.
Measured: Baseline and 6 months
Clinicians' satisfaction with the treatment
The clinicians' satisfaction about the treatment performed will be evaluated using a scale, as performed by Mattos-Silveira et al. (2014). This scale will be applied immediately after the procedure and on 6 months follow-up.
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2016 (estimated)
- Study startJun 2016
- Primary completionNov 2016
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- 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
- 364 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faculty Sao Leopoldo Mandic Campinas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose Carlos P Imparato, Faculty Sao Leopoldo Mandic Campinas
- Investigators
- Jose Carlos P Imparato, Professor, Principal investigator, Faculty Sao Leopoldo Mandic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02782390
- Sponsor's protocol ID
- SLM3
- Acronym
- SLM2078
- Status last verified
- May 2022
- First submitted
- 10 Mar 2016
- Last updated
- 2 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Casagrande L, Dalpian DM, Ardenghi TM, Zanatta FB, Balbinot CE, Garcia-Godoy F, De Araujo FB. Randomized clinical trial of adhesive restorations in primary molars. 18-month results. Am J Dent. 2013 Dec;26(6):351-5.
PubMed 24640441Evans D, Innes N. The Hall Technique: A minimal intervention, child centred approach to managing the carious primary molar. A Users Manual. University of Dundee, 3. ed., 2010.
Innes NP, Ricketts D, Chong LY, Keightley AJ, Lamont T, Santamaria RM. Preformed crowns for decayed primary molar teeth. Cochrane Database Syst Rev. 2015 Dec 31;2015(12):CD005512. doi: 10.1002/14651858.CD005512.pub3.
PubMed 26718872van der Zee V, van Amerongen WE. Short communication: Influence of preformed metal crowns (Hall technique) on the occlusal vertical dimension in the primary dentition. Eur Arch Paediatr Dent. 2010 Oct;11(5):225-7. doi: 10.1007/BF03262751.
PubMed 20932395Miraglia SS, Freitas KB, Pinto JHN. Comparative analyze of the mesion-distal (MD) and gengivo-incisal (GI) distances of the upper central incisors with the instrument Trubyte Tooth Indicator. PGRO - Pós-Grad Rev Odontol 5(2):13-17, 2002.
Magalhaes JB, Zavanelli AC, Zavanelli RA. Analysis of facial proportion and its relation with dental form, rest and occlusal vertical dimension between institutionalized students. Rev Odontol UNESP 40(5): 215-221, 2011.
Tesch FC, Oliveira BH, Leao A. [Semantic equivalence of the Brazilian version of the Early Childhood Oral Health Impact Scale]. Cad Saude Publica. 2008 Aug;24(8):1897-909. doi: 10.1590/s0102-311x2008000800018. Portuguese.
PubMed 18709230Martins MT, Ferreira FM, Oliveira AC, Paiva SM, Vale MP, Allison PJ, Pordeus IA. Preliminary validation of the Brazilian version of the Child Perceptions Questionnaire 8-10. Eur J Paediatr Dent. 2009 Sep;10(3):135-40.
PubMed 19761288Furtado GE, Sousa ML, Barbosa TS, Wada RS, Martinez-Mier EA, Almeida ME. [Perceptions of dental fluorosis and evaluation of agreement between parents and children: validation of a questionnaire]. Cad Saude Publica. 2012 Aug;28(8):1493-505. doi: 10.1590/s0102-311x2012000800008. Portuguese.
PubMed 22892969Mattos-Silveira J, Floriano I, Ferreira FR, Vigano ME, Frizzo MA, Reyes A, Novaes TF, Moriyama CM, Raggio DP, Imparato JC, Mendes FM, Braga MM. New proposal of silver diamine fluoride use in arresting approximal caries: study protocol for a randomized controlled trial. Trials. 2014 Nov 19;15:448. doi: 10.1186/1745-6215-15-448.
PubMed 25409545Wong DL, Baker CM. Pain in children: comparison of assessment scales. Pediatr Nurs. 1988 Jan-Feb;14(1):9-17. No abstract available.
PubMed 3344163Sharaf AA, Farsi NM. A clinical and radiographic evaluation of stainless steel crowns for primary molars. J Dent. 2004 Jan;32(1):27-33. doi: 10.1016/s0300-5712(03)00136-2.
PubMed 14659715SILNESS J, LOE H. PERIODONTAL DISEASE IN PREGNANCY. II. CORRELATION BETWEEN ORAL HYGIENE AND PERIODONTAL CONDTION. Acta Odontol Scand. 1964 Feb;22:121-35. doi: 10.3109/00016356408993968. No abstract available.
PubMed 14158464Pascareli-Carlos AM, Tedesco TK, Calvo AFB, Floriano I, Gimenez T, Goncalves MDS, Calumby D, Imparato JCP. Survival rate of the Hall technique compared with resin composite restoration in multi-surface cavities in primary teeth: a 1-year randomized clinical trial. J Appl Oral Sci. 2023 Oct 9;31:e20230048. doi: 10.1590/1678-7757-2023-0048. eCollection 2023.
PubMed 37820181
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Hall Technique in Atypical Lesions on Primary Teeth: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02782390
- Acronym / sponsor ID
- SLM2078 / SLM3
- Conditions
- Dental Caries
- Keywords
- Stainless dental crown, Composite Resin, Primary teeth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 364 participants (actual)
- Lead sponsor
- Faculty Sao Leopoldo Mandic CampinasUniversity, hospital or other
- Study start
- Jun 2016 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 25 May 2016 (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.
Atypical carious cavities could be defined as carious lesions in more than 2 surfaces of the same tooth. Dental practitioners have shown difficulties related to material's maintenance in such type of cavities and therefore, several treatment options have been used. However, most of them have shown a great failure percentage. A randomized clinical trial will be developed with the objective of assessing the Hall technique in comparison with the composite resin incremental technique in 364 primary molars' atypical carious lesions of children between 4 and 9 years old. Initially, two previously calibrated examiners will perform caries diagnosis by means of visual assessment and intraoral examination. Selected teeth will be randomly allocated into two groups. Teeth in the first group will be submitted to prefabricated stainless steel crowns treatment (Hall technique); and the other, to composite resin incremental technique, which will be always placed under rubber dam isolation. Lesions' clinical and radiographic follow-up will be conducted after 6 and 12 months.
Treatment's efficacy will be assessed by means of four main outcomes:
- Longevity, marginal adaptation, possible modification in patients' vertical dimension, and caries lesion progression;
- Patient-focused criteria (satisfaction, discomfort and quality of life impact);
- cost-efficacy; and
- Treatment-related parents', children' and operators' perception.
Other variables could be further analysed as secondary outcomes, such as techniques performing time among operators, impact of the socio-economic characteristics on restorations' longevity, and restorations' type impact on the antagonist tooth. Comparisons between groups will be addressed using the Kaplan-Meier survival test as well as Long-Rank test. Cox Regression will be used to enable the assessment of other variables' influence in the results. Significance value of 5% will be adopted for all analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hall Technique | Experimental | Other: Dental Restoration with Stainless Crownsingle placement of stainless dental crowns on atypical cavities |
| Composite Resin | Active comparator | Other: Dental Restoration with Composite Resinsingle placement of composite resin on atypical cavities |
Who may qualify
- Ages
- 4 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- children must have at least one molar with atypical caries lesion (involving more than two surfaces);
- parents or legal guardians accept and sign the informed consent form.
Key exclusion criteria (2 listed)
- children with special needs and/or systematic diseases with oral impairment;
- teeth with spontaneous painful symptoms or necrotized and teeth presenting restorations, sealants, developmental enamel defects, pulp exposure or other signs related to endodontic treatment.
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 |
|---|---|---|
| Dental Restoration with Stainless CrownLesions allocated to this group will be treated with stainless dental crowns according to the Hall Technique protocol (Evans \& Innes, 2010). | Other | Hall Technique |
| Dental Restoration with Composite ResinSurfaces allocated to this group will be treated with composite resin (Z250, 3M ESPE, USA) according to the manufacturer's instructions. Initially, local anesthesia and rubber dam adaptation will be performed. Then, 37% phosphoric acid will be applied on the surface for 15 seconds, followed by spray of water/air for at least 15 seconds. Then, the adhesive system (Single Bond, 3M ESPE, USA) will be applied and light cured according to the manufacturer's instructions. Finally, composite resin (Z250, 3M ESPE, USA) will be applied and light cured according to the manufacturer's instructions. | Other | Composite Resin |
Primary outcome
Clinical longevity of restoration
Time frame: Change from baseline until 6 and 12 months
The clinical evaluation will be performed by the non-blinded examiners. The examiner will use the criteria proposed by Innes et al. (2007) for both interventions.
16 secondary outcomes
Change in patient's vertical dimension
Time frame: Baseline, 30 days, 6 and 12 months
Antagonist's level of intrusion
Time frame: Baseline, 6 and 12 months
Treatments' cost-efficacy
Time frame: Through study completion (12 months)
Clinical caries lesion progression
Time frame: Baseline, 6 and 12 months
Impact on children's quality of life (4-5 years old)
Time frame: Baseline and 6 months
Impact on children's quality of life (6-9 years old)
Time frame: Baseline and 6 months
Children's perceptions about the treatment
Time frame: Baseline, 6 and 12 months
Children's satisfaction with the treatment
Time frame: Baseline and 6 months
Children self-reported discomfort
Time frame: Baseline
Marginal adaptation of the stainless steel crowns
Time frame: Baseline, 6 and 12 months
Radiographical caries lesion progression
Time frame: Baseline, 6 and 12 months
Biofilm retention of the stainless steel crowns
Time frame: Baseline, 6 and 12 months
Caregivers' perceptions about the treatment
Time frame: Baseline, 6 and 12 months
Clinicians' perceptions about the treatment
Time frame: Baseline, 6 and 12 months
Caregivers' satisfaction with the treatment
Time frame: Baseline and 6 months
Clinicians' satisfaction with the treatment
Time frame: Baseline and 6 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 2 Jun 2022.
- Background: PubMed 24640441Casagrande L, Dalpian DM, Ardenghi TM, Zanatta FB, Balbinot CE, Garcia-Godoy F, De Araujo FB. Randomized clinical trial of adhesive restorations in primary molars. 18-month results. Am J Dent. 2013 Dec;26(6):351-5.
- BackgroundEvans D, Innes N. The Hall Technique: A minimal intervention, child centred approach to managing the carious primary molar. A Users Manual. University of Dundee, 3. ed., 2010.
- Background: PubMed 26718872Innes NP, Ricketts D, Chong LY, Keightley AJ, Lamont T, Santamaria RM. Preformed crowns for decayed primary molar teeth. Cochrane Database Syst Rev. 2015 Dec 31;2015(12):CD005512. doi: 10.1002/14651858.CD005512.pub3.
- Background: PubMed 20932395van der Zee V, van Amerongen WE. Short communication: Influence of preformed metal crowns (Hall technique) on the occlusal vertical dimension in the primary dentition. Eur Arch Paediatr Dent. 2010 Oct;11(5):225-7. doi: 10.1007/BF03262751.
- BackgroundMiraglia SS, Freitas KB, Pinto JHN. Comparative analyze of the mesion-distal (MD) and gengivo-incisal (GI) distances of the upper central incisors with the instrument Trubyte Tooth Indicator. PGRO - Pós-Grad Rev Odontol 5(2):13-17, 2002.
- BackgroundMagalhaes JB, Zavanelli AC, Zavanelli RA. Analysis of facial proportion and its relation with dental form, rest and occlusal vertical dimension between institutionalized students. Rev Odontol UNESP 40(5): 215-221, 2011.
- Background: PubMed 18709230Tesch FC, Oliveira BH, Leao A. [Semantic equivalence of the Brazilian version of the Early Childhood Oral Health Impact Scale]. Cad Saude Publica. 2008 Aug;24(8):1897-909. doi: 10.1590/s0102-311x2008000800018. Portuguese.
- Background: PubMed 19761288Martins MT, Ferreira FM, Oliveira AC, Paiva SM, Vale MP, Allison PJ, Pordeus IA. Preliminary validation of the Brazilian version of the Child Perceptions Questionnaire 8-10. Eur J Paediatr Dent. 2009 Sep;10(3):135-40.
- Background: PubMed 22892969Furtado GE, Sousa ML, Barbosa TS, Wada RS, Martinez-Mier EA, Almeida ME. [Perceptions of dental fluorosis and evaluation of agreement between parents and children: validation of a questionnaire]. Cad Saude Publica. 2012 Aug;28(8):1493-505. doi: 10.1590/s0102-311x2012000800008. Portuguese.
- Background: PubMed 25409545Mattos-Silveira J, Floriano I, Ferreira FR, Vigano ME, Frizzo MA, Reyes A, Novaes TF, Moriyama CM, Raggio DP, Imparato JC, Mendes FM, Braga MM. New proposal of silver diamine fluoride use in arresting approximal caries: study protocol for a randomized controlled trial. Trials. 2014 Nov 19;15:448. doi: 10.1186/1745-6215-15-448.
- Background: PubMed 3344163Wong DL, Baker CM. Pain in children: comparison of assessment scales. Pediatr Nurs. 1988 Jan-Feb;14(1):9-17. No abstract available.
- Background: PubMed 14659715Sharaf AA, Farsi NM. A clinical and radiographic evaluation of stainless steel crowns for primary molars. J Dent. 2004 Jan;32(1):27-33. doi: 10.1016/s0300-5712(03)00136-2.
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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.
Jose Carlos P Imparato, Professor principal investigator
Faculty Sao Leopoldo Mandic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dental Restoration with Stainless Crown and Dental Restoration with Composite Resin in people with Dental Caries, run by Faculty Sao Leopoldo Mandic Campinas 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 2 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 2 Jun 2022. 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?
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?
Clinical longevity of restoration (time frame: Change from baseline until 6 and 12 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 NCT02782390, which also lists 14 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 2 Jun 2022.