Dental CariesNCT02969538
Effect of Shortening the Etching Time on the Clinical Performance of Resin Composite Restorations in Primary Teeth
A study testing Total etching time and Half-reduced etching time in people with Dental Caries, run by Universidade Federal de Santa Maria at 1 site in Brazil.
Trial summary
The aim of this study is to evaluate the effect of shortening the etching time on the 18-month clinical performance of resin composite restorations in primary molars after partial carious removal. Read more about this study
- Who is it for?
- Ages 5 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- Total etching time and Half-reduced etching time
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteBrazil
- Study dates
- Nov 2016to Nov 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 5 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Active carious lesion in middle dentin limited to the occlusal surfaces of primary molars.
Who cannot join
- Children who refuse or fail to cooperate with the completion of clinical procedure;
- Teeth without antagonist;
- Carious lesions in inner half of dentin;
- Presence of painful symptoms or signs of pulpal changes.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Federal University of Santa Maria
Santa Maria, Rio Grande do Sul, 97015372
Tathiane Lenzi, PhD, +55 55 3220 9266, tathilenzi@usp.br
About this study
The aim of this study is to evaluate the effect of shortening the etching time on the 18-month clinical performance of resin composite restorations in primary molars after partial carious removal. This randomized clinical trial will include subjects (5-10 year-old children) selected at Pediatric Clinic of Federal University of Santa Maria. The sample will consist of 70 primary molars presenting active cavitated carious lesions (with radiographic involvement of the outer half of the dentin), located on the occlusal surface. The sample will be randomly divided into two groups according to the etching time of the dentin prior adhesive application (Adper Single Bond 2; 3M ESPE): recommend by manufacturers (15 seconds) and half-reduced etching time (7 seconds). The restorations will be clinically followed every 6 months for up to 18-month using the FDI criteria for clinical evaluation. Survival estimates for restoration longevity will be evaluated using the Kaplan-Meier method.
Read the detailed description
The aim of this study is to evaluate the effect of shortening the etching time on the 18-month clinical performance of resin composite restorations in primary molars after partial carious removal. This randomized clinical trial will include subjects (5-10 year-old children) selected at Pediatric Clinic of Federal University of Santa Maria. The sample will consist of 70 primary molars presenting active cavitated carious lesions (with radiographic involvement of the outer half of the dentin), located on the occlusal surface. The sample will be randomly divided into two groups according to the etching time of the dentin prior adhesive application (Adper Single Bond 2; 3M ESPE): applying of 35% phosphoric acid by 15 s - recommend by manufacturers and half-reduced etching time (7 s). The restorations will be clinically followed every 6 months for up to 18-month using the FDI criteria for clinical evaluation. Survival estimates for restoration longevity will be evaluated using the Kaplan-Meier method.
- Conditions
- Dental Caries
- Being tested
- Total etching time, Half-reduced etching time
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total etching timeOther
Also called (dental conditioner - 35% phosphoric acid)
Apply 35% phosphoric acid on dentin and enamel by 15 seconds.
Half-reduced etching timeOther
Also called (dental conditioner - 35% phosphoric acid)
Apply 35% phosphoric acid on enamel by 15 seconds and dentin by 7 seconds.
| Study group | Role | What they receive |
|---|---|---|
| Total etching time | Other | Dentin etching (35% phosphoric acid) by time recommend by manufacturer (15 seconds) Receives: Other: Total etching time |
| Half-reduced etching time | Experimental | Dentin etching (35% phosphoric acid) by 7 seconds Receives: Other: Half-reduced etching time |
What is being measured
The primary outcome is the main question the study is designed to answer.
Failure of restorations
Measured: 18 months after restorations' placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionMay 2017 (estimated)
- Study completionNov 2017 (estimated)
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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Santa Maria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tathiane Lenzi, Universidade Federal de Santa Maria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02969538
- Sponsor's protocol ID
- UFSantaMaria1
- Status last verified
- Nov 2016
- First submitted
- 4 Apr 2016
- Last updated
- 21 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Shortening the Etching Time on the Clinical Performance of Resin Composite Restorations in Primary Teeth
- ClinicalTrials.gov ID
- NCT02969538
- Acronym / sponsor ID
- UFSantaMaria1
- Conditions
- Dental Caries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Universidade Federal de Santa MariaUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- May 2017 (estimated)
- Study completion
- Nov 2017 (estimated)
- First posted
- 21 Nov 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.
The aim of this study is to evaluate the effect of shortening the etching time on the 18-month clinical performance of resin composite restorations in primary molars after partial carious removal. This randomized clinical trial will include subjects (5-10 year-old children) selected at Pediatric Clinic of Federal University of Santa Maria. The sample will consist of 70 primary molars presenting active cavitated carious lesions (with radiographic involvement of the outer half of the dentin), located on the occlusal surface. The sample will be randomly divided into two groups according to the etching time of the dentin prior adhesive application (Adper Single Bond 2; 3M ESPE): recommend by manufacturers (15 seconds) and half-reduced etching time (7 seconds). The restorations will be clinically followed every 6 months for up to 18-month using the FDI criteria for clinical evaluation. Survival estimates for restoration longevity will be evaluated using the Kaplan-Meier method.
Detailed description
The aim of this study is to evaluate the effect of shortening the etching time on the 18-month clinical performance of resin composite restorations in primary molars after partial carious removal. This randomized clinical trial will include subjects (5-10 year-old children) selected at Pediatric Clinic of Federal University of Santa Maria. The sample will consist of 70 primary molars presenting active cavitated carious lesions (with radiographic involvement of the outer half of the dentin), located on the occlusal surface. The sample will be randomly divided into two groups according to the etching time of the dentin prior adhesive application (Adper Single Bond 2; 3M ESPE): applying of 35% phosphoric acid by 15 s - recommend by manufacturers and half-reduced etching time (7 s). The restorations will be clinically followed every 6 months for up to 18-month using the FDI criteria for clinical evaluation. Survival estimates for restoration longevity will be evaluated using the Kaplan-Meier method.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Total etching time | Other | Other: Total etching timeDentin etching (35% phosphoric acid) by time recommend by manufacturer (15 seconds) |
| Half-reduced etching time | Experimental | Other: Half-reduced etching timeDentin etching (35% phosphoric acid) by 7 seconds |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Active carious lesion in middle dentin limited to the occlusal surfaces of primary molars.
Key exclusion criteria (4 listed)
- Children who refuse or fail to cooperate with the completion of clinical procedure;
- Teeth without antagonist;
- Carious lesions in inner half of dentin;
- Presence of painful symptoms or signs of pulpal changes.
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 |
|---|---|---|
| Total etching timeAlso: (dental conditioner - 35% phosphoric acid)Apply 35% phosphoric acid on dentin and enamel by 15 seconds. | Other | Total etching time |
| Half-reduced etching timeAlso: (dental conditioner - 35% phosphoric acid)Apply 35% phosphoric acid on enamel by 15 seconds and dentin by 7 seconds. | Other | Half-reduced etching time |
Primary outcome
Failure of restorations
Time frame: 18 months after restorations' placement
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2016.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total etching time and Half-reduced etching time in people with Dental Caries, run by Universidade Federal de Santa Maria 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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 21 Nov 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rachel Rocha, PhD (*55 5532209266, rachelrocha@smail.ufsm.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Failure of restorations (time frame: 18 months after restorations' placement). 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 21 Nov 2016.