Dental CariesCEPECO4NCT03785769
Pre-etching of Dentin Before Restorations With High Viscosity Glass Ionomer Cement
A study testing HVGIC restoration with pre-etching and HVGIC restoration with non pre-etching in people with Dental Caries, run by Universidade Ibirapuera at 1 site in Brazil.
Trial summary
The objective of this randomized clinical trial is to evaluate the survival of restoration with high viscosity glass ionomer cement (HVGIC) with pre-etching with polyacrilic acid compared with no pre-etching in order to treat occlusoproximais caries lesion in primary molars, as well as the impact of those treatments… Read more about this study
- Who is it for?
- Ages 4 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- HVGIC restoration with pre-etching and HVGIC restoration with non pre-etching
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jan 2022to 1 Dec 2024
- 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 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patients with carious lesion of occlusoproximais in primary molars
Who cannot join
- Patients will be excluded with special needs, using orthodontics devices and/or systemic diseases which may affect the oral cavity.
- Also, teeth with pulp exposure, spontaneous pain, mobility, presence of abscess or fistula next to the tooth, teeth with restorations, sealants or enamel formation defects will also be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Pre-etching of Dentin on Survival of Restorations With High Viscosity Glass Ionomer Cement in the Atraumatic Restorative Treatment - Randomized Clinical Trial Restorations With High Viscosity Glass Ionomer Cement
The objective of this randomized clinical trial is to evaluate the survival of restoration with high viscosity glass ionomer cement (HVGIC) with pre-etching with polyacrilic acid compared with no pre-etching in order to treat occlusoproximais caries lesion in primary molars, as well as the impact of those treatments in the caries lesion progression, the cost-efficacy of the procedures and the discomfort reported by the patient. Children of 4 to 8 years will be selected in the Pediatric Dentistry Clinic of Universidade Ibirapuera. 192 teeth will be randomized in 2 experimental groups: (1) HVGIC restoration with pre-etching and (2) HVGIC restoration with no pre-etching. Will be considered as primary outcome the survival of the restoration evaluated after 6, 12, and 24 months by two trained examiners. The carious lesions progression will be evaluated after 24 months of follow-up. The time of the treatments and the cost of the materials will be considered to estimate the cost-efficacy of each treatment. The discomfort reported by the participant will be measured after each procedure following the Wong-Baker scale. For the primary outcome, Kaplan-Meier survival and the Long-Rank test will be used in order to compare the two groups. Cox regression will be performed in order to evaluate thee influence of explanatory variables on the outcome.
- Conditions
- Dental Caries
- Being tested
- HVGIC restoration with pre-etching, HVGIC restoration with non pre-etching
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HVGIC restoration with pre-etchingProcedure or surgery
Pre-etching of the surface with polyacrylic acid for 10 s, followed by washing and drying the cavity with cotton balls; and fill with HVGIC, inserted into the cavity with the aid of an insertion spatula and adapted to the cavity by the digital pressure technique.
HVGIC restoration with non pre-etchingProcedure or surgery
Restoration with HVGIC, inserted into the cavity with the aid of an insertion spatula and adapted to the cavity by the digital pressure technique.
| Study group | Role | What they receive |
|---|---|---|
| HVGIC restoration with pre-etching | Active comparator | Pre-etching of the surface with polyacrylic acid for 10 s, followed by HVGIC restoration. Receives: Procedure: HVGIC restoration with pre-etching |
| HVGIC restoration with non pre-etching | Experimental | HVGIC restoration without the pre-etching of the surface. Receives: Procedure: HVGIC restoration with non pre-etching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival of restorations
Comparing the survival of HVGIC restorations without pre-etching with HVGIC restorations with pre-etching by clinical assessment using a criteria proposed by Roleveld et al., 2006.
Measured: 24 months
Secondary outcomes (3)
Caries lesion progression will be evaluated by comaparison of radiograph immediately after the restoration
The caries lesion progression will be evaluated by comaparison of radiograph immediately after the restoration and after 24 months.
Measured: Immediately after the restoration and 24 months
Cost-efficacy
The duration of the treatments (time of treatment) and the cost of the materials used will be considered for the estimation of the cost-efficacy of the treatments by a ratio - cost/efficacy, being efficacy considered the tooth survival.
Measured: 24 months.
Discomfort regarding the treatment options by a Wong-Baker FACES pain rating scale
Children-reported discomfort regarding the treatment options by a Wong-Baker FACES pain rating scale. The scale present 6 different faces since "very happy" until "very sad" with the treatment.
Measured: Immediately after the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2018
- Study start1 Jan 2022 (estimated)
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Dec 2024 (estimated)
Why it stopped: The Outbreak of COVID-19.
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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Ibirapuera
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tamara Kerber Tedesco, Universidade Ibirapuera
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03785769
- Sponsor's protocol ID
- Unib4
- Acronym
- CEPECO4
- Status last verified
- May 2022
- First submitted
- 18 Dec 2018
- Last updated
- 1 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data will be available on Mendeley database.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pre-etching of Dentin on Survival of Restorations With High Viscosity Glass Ionomer Cement in the Atraumatic Restorative Treatment - Randomized Clinical Trial Restorations With High Viscosity Glass Ionomer Cement
- ClinicalTrials.gov ID
- NCT03785769
- Acronym / sponsor ID
- CEPECO4 / Unib4
- Conditions
- Dental Caries
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The Outbreak of COVID-19.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Universidade IbirapueraUniversity, hospital or other
- Study start
- 1 Jan 2022 (estimated)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 24 Dec 2018 (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.
The objective of this randomized clinical trial is to evaluate the survival of restoration with high viscosity glass ionomer cement (HVGIC) with pre-etching with polyacrilic acid compared with no pre-etching in order to treat occlusoproximais caries lesion in primary molars, as well as the impact of those treatments in the caries lesion progression, the cost-efficacy of the procedures and the discomfort reported by the patient. Children of 4 to 8 years will be selected in the Pediatric Dentistry Clinic of Universidade Ibirapuera. 192 teeth will be randomized in 2 experimental groups: (1) HVGIC restoration with pre-etching and (2) HVGIC restoration with no pre-etching. Will be considered as primary outcome the survival of the restoration evaluated after 6, 12, and 24 months by two trained examiners. The carious lesions progression will be evaluated after 24 months of follow-up. The time of the treatments and the cost of the materials will be considered to estimate the cost-efficacy of each treatment. The discomfort reported by the participant will be measured after each procedure following the Wong-Baker scale. For the primary outcome, Kaplan-Meier survival and the Long-Rank test will be used in order to compare the two groups. Cox regression will be performed in order to evaluate thee influence of explanatory variables on the outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HVGIC restoration with pre-etching | Active comparator | Procedure: HVGIC restoration with pre-etchingPre-etching of the surface with polyacrylic acid for 10 s, followed by HVGIC restoration. |
| HVGIC restoration with non pre-etching | Experimental | Procedure: HVGIC restoration with non pre-etchingHVGIC restoration without the pre-etching of the surface. |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Patients with carious lesion of occlusoproximais in primary molars
Key exclusion criteria (2 listed)
- Patients will be excluded with special needs, using orthodontics devices and/or systemic diseases which may affect the oral cavity.
- Also, teeth with pulp exposure, spontaneous pain, mobility, presence of abscess or fistula next to the tooth, teeth with restorations, sealants or enamel formation defects will also be excluded.
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 |
|---|---|---|
| HVGIC restoration with pre-etchingPre-etching of the surface with polyacrylic acid for 10 s, followed by washing and drying the cavity with cotton balls; and fill with HVGIC, inserted into the cavity with the aid of an insertion spatula and adapted to the cavity by the digital pressure technique. | Procedure or surgery | HVGIC restoration with pre-etching |
| HVGIC restoration with non pre-etchingRestoration with HVGIC, inserted into the cavity with the aid of an insertion spatula and adapted to the cavity by the digital pressure technique. | Procedure or surgery | HVGIC restoration with non pre-etching |
Primary outcome
Survival of restorations
Time frame: 24 months
Comparing the survival of HVGIC restorations without pre-etching with HVGIC restorations with pre-etching by clinical assessment using a criteria proposed by Roleveld et al., 2006.
3 secondary outcomes
Caries lesion progression will be evaluated by comaparison of radiograph immediately after the restoration
Time frame: Immediately after the restoration and 24 months
Cost-efficacy
Time frame: 24 months.
Discomfort regarding the treatment options by a Wong-Baker FACES pain rating scale
Time frame: Immediately after the treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2022.
- Individual participant dataSharing planned: Yes. Individual participant data will be available on Mendeley database.
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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 HVGIC restoration with pre-etching and HVGIC restoration with non pre-etching in people with Dental Caries, run by Universidade Ibirapuera 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 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: withdrawn, as of the sponsor's last update on 1 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 was withdrawn before enrolling participants, so there are no results.
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?
Survival of restorations (time frame: 24 months). 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 1 Jun 2022.