Dental CariesNCT01924611
Two Years Survival Rate of Class II ART Restorations in Primary Molars Using Two Ways to Avoid Saliva Contamination
A study testing Atraumatic Restorative Technique using cotton rolls and Atraumatic Restorative Technique in people with Dental Caries, run by Federal University of Paraíba at 1 site in Brazil.
Trial summary
AIM: To evaluate influence of two methods to avoid saliva contamination on the survival rate of atraumatic restorations in primary molars. 232 children, aged between 6-7 years, of both genders, were selected having one primary molar with a proximal dentine lesion. Read more about this study
- Who is it for?
- Ages 6 to 7 years
- Conditions the study is for
- Dental Caries
- What is being tested?
- Atraumatic Restorative Technique using cotton rolls and Atraumatic Restorative Technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 232 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2004to Mar 2007
- 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 7 years
- All sexes
- Child
Who may be able to join
- Children of both genders enrolled in school,
- Children aged between 6 and 7 years,
- having cavity with access to ART hand instruments,
- cavity with a mesio-distal maximum dimension of 1mm and a buccal-lingual maximum dimension of 2mm length, measured on the oclusal surface,
- proximal surface of the adjacent tooth should be unimpaired, without visible lesions,
Who cannot join
- Cavity lesions having pulpal involvement, swelling, fistula or pain were not included in the study,
- Children out of the age range,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Two Years Survival Rate of Class II ART Restorations in Primary Molars Using Either Rubber Dam or Cotton Rolls.
AIM: To evaluate influence of two methods to avoid saliva contamination on the survival rate of atraumatic restorations in primary molars. 232 children, aged between 6-7 years, of both genders, were selected having one primary molar with a proximal dentine lesion. The children were randomly divided into two groups: a control group with class II ART restoration made using cotton rolls and an experimental group using rubber dam. The restorations were made and they were followed up every six months. After two years, the results were compilated and analyzed.
Read the detailed description
To evaluate influence of two methods to avoid saliva contamination on the survival rate of atraumatic restorations in primary molars. 232 children, aged between 6-7 years, of both genders, were selected having one primary molar with a proximal dentine lesion. The children were randomly divided into two groups: a control group with class II ART restoration made using cotton rolls and an experimental group using rubber dam. The restorations were made and they were followed up every six months. After two years, the results were compilated and analyzed.
- Conditions
- Dental Caries
- Being tested
- Atraumatic Restorative Technique using cotton rolls, Atraumatic Restorative Technique
- Keywords
- Dental caries, Atraumatic Restorative 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 Technique using cotton rollsProcedure or surgery
Also called Atraumatic Restorative Technique
Atraumatic Restorative Technique using cotton rolls.
Atraumatic Restorative TechniqueProcedure or surgery
Atraumatic Restorative Technique is typically used in Minimally invasive Dentistry.
This restoration technique is made using only hand instruments and is possible to be carried out in children in schools.
This particular time, the isolation of the surgical/tooth area was made using rubber dam as saliva barrier.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Atraumatic Restorative Technique using cotton rolls. Receives: Procedure: Atraumatic Restorative Technique using cotton rolls |
| Experimental Group | Experimental | Atraumatic Restorative Technique using rubber dam. Receives: Procedure: Atraumatic Restorative Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of teeth with fractured restorations.
The teeth were assessed every 6 months for a period of 2 years and they were graded according to restoration fractures.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2013 (estimated)
- Study startSep 2004
- Primary completionMar 2007
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 232 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Paraíba
- Sponsor type
- University, hospital or other
- Collaborators
- Academic Centre for Dentistry in Amsterdam
- Responsible party
- Principal investigator, Thiago Saads Carvalho, Federal University of Paraíba
- Investigators
- Evert van Amerongen, DDS, PhD, Professor, Study director, Academic Centre for Dentistry in AmsterdamFabio Correia Sampaio, DDS PhD PostDoc, Study director, UFPB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01924611
- Sponsor's protocol ID
- CEP 134/04
- Status last verified
- Aug 2013
- First submitted
- 13 Aug 2013
- Last updated
- 16 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Two Years Survival Rate of Class II ART Restorations in Primary Molars Using Either Rubber Dam or Cotton Rolls.
- ClinicalTrials.gov ID
- NCT01924611
- Acronym / sponsor ID
- CEP 134/04
- Conditions
- Dental Caries
- Keywords
- Dental caries, Atraumatic Restorative Technique
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 232 participants (actual)
- Lead sponsor
- Federal University of ParaíbaUniversity, hospital or other
- Collaborators
- Academic Centre for Dentistry in Amsterdam
- Study start
- Sep 2004
- Primary completion
- Mar 2007 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 16 Aug 2013 (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.
AIM: To evaluate influence of two methods to avoid saliva contamination on the survival rate of atraumatic restorations in primary molars. 232 children, aged between 6-7 years, of both genders, were selected having one primary molar with a proximal dentine lesion. The children were randomly divided into two groups: a control group with class II ART restoration made using cotton rolls and an experimental group using rubber dam. The restorations were made and they were followed up every six months. After two years, the results were compilated and analyzed.
Detailed description
To evaluate influence of two methods to avoid saliva contamination on the survival rate of atraumatic restorations in primary molars. 232 children, aged between 6-7 years, of both genders, were selected having one primary molar with a proximal dentine lesion. The children were randomly divided into two groups: a control group with class II ART restoration made using cotton rolls and an experimental group using rubber dam. The restorations were made and they were followed up every six months. After two years, the results were compilated and analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Procedure: Atraumatic Restorative Technique using cotton rollsAtraumatic Restorative Technique using cotton rolls. |
| Experimental Group | Experimental | Procedure: Atraumatic Restorative TechniqueAtraumatic Restorative Technique using rubber dam. |
Who may qualify
- Ages
- 6 to 7 years
- Sex
- All
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children of both genders enrolled in school,
- Children aged between 6 and 7 years,
- having cavity with access to ART hand instruments,
- cavity with a mesio-distal maximum dimension of 1mm and a buccal-lingual maximum dimension of 2mm length, measured on the oclusal surface,
- proximal surface of the adjacent tooth should be unimpaired, without visible lesions,
Key exclusion criteria (2 listed)
- Cavity lesions having pulpal involvement, swelling, fistula or pain were not included in the study,
- Children out of the age range,
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 Technique using cotton rollsAlso: Atraumatic Restorative TechniqueAtraumatic Restorative Technique using cotton rolls. | Procedure or surgery | Control Group |
| Atraumatic Restorative TechniqueAtraumatic Restorative Technique is typically used in Minimally invasive Dentistry. This restoration technique is made using only hand instruments and is possible to be carried out in children in schools. This particular time, the isolation of the surgical/tooth area was made using rubber dam as saliva barrier. | Procedure or surgery | Experimental Group |
Primary outcome
Number of teeth with fractured restorations.
Time frame: 2 years
The teeth were assessed every 6 months for a period of 2 years and they were graded according to restoration fractures.
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 16 Aug 2013.
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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.
Evert van Amerongen, DDS, PhD, Professor study director
Academic Centre for Dentistry in Amsterdam
Fabio Correia Sampaio, DDS PhD PostDoc study director
UFPB
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Atraumatic Restorative Technique using cotton rolls and Atraumatic Restorative Technique in people with Dental Caries, run by Federal University of Paraíba 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 5 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 16 Aug 2013. 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?
Number of teeth with fractured restorations. (time frame: 2 years). 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 16 Aug 2013.