Dental CariesNCT03143387
Discomfort Evaluation During Atraumatic Restorative Treatment in Children
A study testing Caries removal using only manual instruments and Caries removal using Papacarie gel in people with Dental Caries and Primary Teeth, run by Faculty Sao Leopoldo Mandic Campinas at 1 site in Brazil.
Trial summary
This study evaluates the patient 's discomfort when submitted to partial caries removal through the atraumatic restorative treatment compared to chemo-mechanical caries removal using Papacarie™ gel. Read more about this study
- Who is it for?
- Ages 4 to 9 years
- Conditions the study is for
- Dental Caries, Primary Teeth, Post Dental Restoration
- What is being tested?
- Caries removal using only manual instruments and Caries removal using Papacarie gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jun 2017to 30 Oct 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
- normoreactive,
- in good general health conditions,
- cooperative during screening,
- with at least one oclusal caries cavity in primary molars.
- Caregivers and/or children's parents must accept and sign the consent form.
- Children must accept their participation by nodding (assent).
Who cannot join
- pulp exposition,
- spontaneous pain,
- mobility,
- fistula,
- swollen area around the tooth,
- furcation,
Show all 10Show fewer
- cervical lesion,
- restorations,
- sealants,
- developmental defect of enamel.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Discomfort Evaluation During Atraumatic Restorative Treatment in Children- Clinical Trial
This study evaluates the patient 's discomfort when submitted to partial caries removal through the atraumatic restorative treatment compared to chemo-mechanical caries removal using Papacarie™ gel.
Read the detailed description
This study will evaluate the patient 's discomfort through oximeter (measuring the heart rate of the caries) prior to removal of the carious tissue, and when subjected to partial caries removal through the atraumatic restorative treatment compared to removal of chemo - mechanical caries with Papacarie gel ™.
- Conditions
- Dental Caries, Primary Teeth, Post Dental Restoration
- Being tested
- Caries removal using only manual instruments, Caries removal using Papacarie gel
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caries removal using only manual instrumentsOther
Caries removal using only manual instruments according to Atraumatic Restorative Treatment
Caries removal using Papacarie gelOther
Caries removal using a chemical-mechanical method - Papacarie gel and manual instruments.
| Study group | Role | What they receive |
|---|---|---|
| Atraumatic Restorative Treatment | Active comparator | Partial removal of carious tissue using manual instruments. Receives: Other: Caries removal using only manual instruments |
| Chemo-mechanical Removal | Experimental | Partial removal of carious tissue using manual instruments and the material Chemo-mechanical removal group using Papacarie™gel. Receives: Other: Caries removal using Papacarie gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Discomfort evaluation with Wong-Baker
The discomfort of each type of treatment will be evaluated using the facial scale of Wong-Baker (Wong, Baker, 1998).
This scale indicates the discomfort of an individual who has to choose among six faces. The first image is a smiling happy face, indicating no discomfort, followed by gradually less cheerful expressions, up to the last one which is a very sad face covered by tears, indicating great discomfort. The participant will be asked to choose the face that is more similar to how he/she felt during the treatment immediately after the procedure. This answer should be given solely by the child, which means no parental or professional interference
Measured: immediately after treatment
Discomfort evaluation with heart beat and oxygen saturation
Measured: Before the procedure (when the patient is in the dental chair and there is no intervention), and during the procedure (removal of the cavity tissue).
Secondary outcomes (2)
Time of restorative procedure
Measured: Will be evaluated the time required for removal of the caries tissue only with manual removal and when manual removal with the product Papacárie ™
Operators satisfaction
Measured: immediately after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2017
- Study start1 Jun 2017
- Primary completion15 Oct 2017
- Study completion30 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03143387
- Sponsor's protocol ID
- ART discomfort
- Status last verified
- Dec 2018
- First submitted
- 21 Feb 2017
- Last updated
- 24 Dec 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Berggren U, Meynert G. Dental fear and avoidance: causes, symptoms, and consequences. J Am Dent Assoc. 1984 Aug;109(2):247-51. doi: 10.14219/jada.archive.1984.0328.
PubMed 6590605Bussadori SK, Guedes CC, Bachiega JC, Santis TO, Motta LJ. Clinical and radiographic study of chemical-mechanical removal of caries using Papacarie: 24-month follow up. J Clin Pediatr Dent. 2011 Spring;35(3):251-4. doi: 10.17796/jcpd.35.3.75803m02524625h5.
PubMed 21678665Colares V, Franca C, Ferreira A, Amorim Filho HA, Oliveira MC. Dental anxiety and dental pain in 5- to 12-year-old children in Recife, Brazil. Eur Arch Paediatr Dent. 2013 Feb;14(1):15-9. doi: 10.1007/s40368-012-0001-8. Epub 2013 Jan 30.
PubMed 23532809Frencken JE, Holmgren CJ. Caries management through the Atraumatic Restorative Treatment (ART) approach and glass-ionomers: update 2013. Braz Oral Res. 2014;28:5-8. doi: 10.1590/S1806-83242013000600001. No abstract available.
PubMed 24402057Frencken 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 22824915Mattos-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 25409545Simon AK, Bhumika TV, Nair NS. Does atraumatic restorative treatment reduce dental anxiety in children? A systematic review and meta-analysis. Eur J Dent. 2015 Apr-Jun;9(2):304-309. doi: 10.4103/1305-7456.156841.
PubMed 26038668Staman NM, Townsend JA, Hagan JL. Observational study: discomfort following dental procedures for children. Pediatr Dent. 2013 Jan-Feb;35(1):52-4.
PubMed 23635899Soares FC, Lima RA, Santos Cda F, de Barros MV, Colares V. Predictors of dental anxiety in Brazilian 5-7years old children. Compr Psychiatry. 2016 May;67:46-53. doi: 10.1016/j.comppsych.2016.01.006. Epub 2016 Jan 21.
PubMed 27095334Venkataraghavan K, Kush A, Lakshminarayana C, Diwakar L, Ravikumar P, Patil S, Karthik S. Chemomechanical Caries Removal: A Review & Study of an Indigen-ously Developed Agent (Carie Care (TM) Gel) In Children. J Int Oral Health. 2013 Aug;5(4):84-90. Epub 2013 Aug 28.
PubMed 24155626
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Discomfort Evaluation During Atraumatic Restorative Treatment in Children- Clinical Trial
- ClinicalTrials.gov ID
- NCT03143387
- Acronym / sponsor ID
- ART discomfort
- Conditions
- Dental Caries, Primary Teeth, Post Dental Restoration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Faculty Sao Leopoldo Mandic CampinasUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 15 Oct 2017 (actual)
- Study completion
- 30 Oct 2017 (actual)
- First posted
- 8 May 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 evaluates the patient 's discomfort when submitted to partial caries removal through the atraumatic restorative treatment compared to chemo-mechanical caries removal using Papacarie™ gel.
Detailed description
This study will evaluate the patient 's discomfort through oximeter (measuring the heart rate of the caries) prior to removal of the carious tissue, and when subjected to partial caries removal through the atraumatic restorative treatment compared to removal of chemo - mechanical caries with Papacarie gel ™.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atraumatic Restorative Treatment | Active comparator | Other: Caries removal using only manual instrumentsPartial removal of carious tissue using manual instruments. |
| Chemo-mechanical Removal | Experimental | Other: Caries removal using Papacarie gelPartial removal of carious tissue using manual instruments and the material Chemo-mechanical removal group using Papacarie™gel. |
Who may qualify
- Ages
- 4 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- normoreactive,
- in good general health conditions,
- cooperative during screening,
- with at least one oclusal caries cavity in primary molars.
- Caregivers and/or children's parents must accept and sign the consent form.
Key exclusion criteria (10 listed)
- pulp exposition,
- spontaneous pain,
- mobility,
- fistula,
- swollen area around the tooth,
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 |
|---|---|---|
| Caries removal using only manual instrumentsCaries removal using only manual instruments according to Atraumatic Restorative Treatment | Other | Atraumatic Restorative Treatment |
| Caries removal using Papacarie gelCaries removal using a chemical-mechanical method - Papacarie gel and manual instruments. | Other | Chemo-mechanical Removal |
Primary outcome
Discomfort evaluation with Wong-Baker
Time frame: immediately after treatment
The discomfort of each type of treatment will be evaluated using the facial scale of Wong-Baker (Wong, Baker, 1998). This scale indicates the discomfort of an individual who has to choose among six faces. The first image is a smiling happy face, indicating no discomfort, followed by gradually less cheerful expressions, up to the last one which is a very sad face covered by tears, indicating great discomfort. The participant will be asked to choose the face that is more similar to how he/she felt during the treatment immediately after the procedure. This answer should be given solely by the child, which means no parental or professional interference
Discomfort evaluation with heart beat and oxygen saturation
Time frame: Before the procedure (when the patient is in the dental chair and there is no intervention), and during the procedure (removal of the cavity tissue).
2 secondary outcomes
Time of restorative procedure
Time frame: Will be evaluated the time required for removal of the caries tissue only with manual removal and when manual removal with the product Papacárie ™
Operators satisfaction
Time frame: immediately after treatment
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 24 Dec 2018.
- Background: PubMed 6590605Berggren U, Meynert G. Dental fear and avoidance: causes, symptoms, and consequences. J Am Dent Assoc. 1984 Aug;109(2):247-51. doi: 10.14219/jada.archive.1984.0328.
- Background: PubMed 21678665Bussadori SK, Guedes CC, Bachiega JC, Santis TO, Motta LJ. Clinical and radiographic study of chemical-mechanical removal of caries using Papacarie: 24-month follow up. J Clin Pediatr Dent. 2011 Spring;35(3):251-4. doi: 10.17796/jcpd.35.3.75803m02524625h5.
- Background: PubMed 23532809Colares V, Franca C, Ferreira A, Amorim Filho HA, Oliveira MC. Dental anxiety and dental pain in 5- to 12-year-old children in Recife, Brazil. Eur Arch Paediatr Dent. 2013 Feb;14(1):15-9. doi: 10.1007/s40368-012-0001-8. Epub 2013 Jan 30.
- Background: PubMed 24402057Frencken JE, Holmgren CJ. Caries management through the Atraumatic Restorative Treatment (ART) approach and glass-ionomers: update 2013. Braz Oral Res. 2014;28:5-8. doi: 10.1590/S1806-83242013000600001. No abstract available.
- Background: PubMed 22824915Frencken 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.
- 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 26038668Simon AK, Bhumika TV, Nair NS. Does atraumatic restorative treatment reduce dental anxiety in children? A systematic review and meta-analysis. Eur J Dent. 2015 Apr-Jun;9(2):304-309. doi: 10.4103/1305-7456.156841.
- Background: PubMed 23635899Staman NM, Townsend JA, Hagan JL. Observational study: discomfort following dental procedures for children. Pediatr Dent. 2013 Jan-Feb;35(1):52-4.
- Background: PubMed 27095334Soares FC, Lima RA, Santos Cda F, de Barros MV, Colares V. Predictors of dental anxiety in Brazilian 5-7years old children. Compr Psychiatry. 2016 May;67:46-53. doi: 10.1016/j.comppsych.2016.01.006. Epub 2016 Jan 21.
- Background: PubMed 24155626Venkataraghavan K, Kush A, Lakshminarayana C, Diwakar L, Ravikumar P, Patil S, Karthik S. Chemomechanical Caries Removal: A Review & Study of an Indigen-ously Developed Agent (Carie Care (TM) Gel) In Children. J Int Oral Health. 2013 Aug;5(4):84-90. Epub 2013 Aug 28.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caries removal using only manual instruments and Caries removal using Papacarie gel in people with Dental Caries and Primary Teeth, 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 6 inclusion and 10 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 24 Dec 2018. 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?
Discomfort evaluation with Wong-Baker (time frame: immediately after treatment). The study lists 2 primary outcomes in all. 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 NCT03143387, which also lists 10 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 24 Dec 2018.