Caries; Dentin(ALFSCaRe)NCT03933176
Absence of Liner Following the Selective Caries Removal (ALFSCaRe)
A study testing Restoration of carious lesions in people with Caries; Dentin and Dental Restoration Failure of Marginal Integrity, run by Universidade Federal de Sergipe at 1 site in Brazil.
Trial summary
This randomized, multi-centric, controlled clinical trial will assess the effectiveness of a simplified restorative protocol used after the selective carious tissue removal in posterior teeth presenting deep carious lesions. Read more about this study
- Who is it for?
- Ages 6 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Caries; Dentin, Dental Restoration Failure of Marginal Integrity
- What is being tested?
- Restoration of carious lesions
- 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
- 30 Jun 2019to Sep 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 6 to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Molar presenting deep carious lesion;
Who cannot join
- Non-vital teeth or teeth presenting pulpitis;
- Cavity margins in dentin;
- Presence of non-carious cervical lesions;
- The necessity of restoration involving any cusp replacement.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Department of Dentistry/ Federal University of Sergipe
Aracaju, Sergipe, 49060100
About this study
Official title: Is the Use of a Glass Ionomer Liner Necessary After Selective Carious Tissue Removal?
This randomized, multi-centric, controlled clinical trial will assess the effectiveness of a simplified restorative protocol used after the selective carious tissue removal in posterior teeth presenting deep carious lesions. Only a regular bulk-fill composite will be used in the simplified restorative protocol following the application of universal adhesive. A liner with resin-modified glass ionomer will be used over the pulpal floor before the composite placement in the control group. The longevity of restorative procedures and post-operative sensitivity were defined as the main and secondary outcomes.
- Being tested
- Restoration of carious lesions
- Keywords
- Glass ionomer, Bulk-Fill Composite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Restoration of carious lesionsProcedure or surgery
Selective carious tissue removal followed by restoration of the cavity using composite resin.
| Study group | Role | What they receive |
|---|---|---|
| Simplified restorative procedure | Experimental | After selective carious tissue removal, the universal adhesive (Adper Universal; 3M ESPE, St. Paul, MN, EUA) will be applied on the cavity walls. The cavity will be restored using a single increment of Filtek One Bulk Fill (3M ESPE, St. Paul, MN, EUA). Receives: Procedure: Restoration of carious lesions |
| Control | Active comparator | A thin layer of resin-modified glass ionomer (Ionoseal (Voco America Inc., Briarcliff Manor, NY, EUA) will be placed on the pulpal floor of the cavity. Then, the adhesive and composite will be used following the same directions defined for the experimental condition. Receives: Procedure: Restoration of carious lesions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Longevity of restoration
Assessment of any failure in restorations according to the FDI World Dental Federation criteria.
Measured: Annual evaluation during 5 years
Secondary outcomes (1)
Tooth sensitivity
The participants will self-assess their level of tooth sensitivity of the restored teeth using a visual analogue scale of 0-10 (0 indicating absence of pain; and 10 the worst pain possible) oriented by both verbal description and Wong-Baker facial grimace scales.
Measured: 15 days after the restorative procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2019
- Study start30 Jun 2019
- Primary completion1 Nov 2020
- Study completionSep 2024 (estimated)
Why it stopped: COVID-19 pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caries; DentinStudies 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 Federal de Sergipe
- Sponsor type
- University, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico, Federal University of Pelotas, University of Brasilia, Universidade Federal do Ceara, Federal University of Uberlandia, Universidade Veiga de Almeida
- Responsible party
- Principal investigator, André Luis Faria e Silva, Universidade Federal de Sergipe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03933176
- Sponsor's protocol ID
- UFS/Prodonto
- Acronym
- (ALFSCaRe)
- Status last verified
- Jun 2023
- First submitted
- 26 Apr 2019
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is the Use of a Glass Ionomer Liner Necessary After Selective Carious Tissue Removal?
- ClinicalTrials.gov ID
- NCT03933176
- Acronym / sponsor ID
- (ALFSCaRe) / UFS/Prodonto
- Keywords
- Glass ionomer, Bulk-Fill Composite
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: COVID-19 pandemic
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Universidade Federal de SergipeUniversity, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico, Federal University of Pelotas, University of Brasilia, Universidade Federal do Ceara, Federal University of Uberlandia, Universidade Veiga de Almeida
- Study start
- 30 Jun 2019 (actual)
- Primary completion
- 1 Nov 2020 (actual)
- Study completion
- Sep 2024 (estimated)
- First posted
- 1 May 2019 (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 randomized, multi-centric, controlled clinical trial will assess the effectiveness of a simplified restorative protocol used after the selective carious tissue removal in posterior teeth presenting deep carious lesions. Only a regular bulk-fill composite will be used in the simplified restorative protocol following the application of universal adhesive. A liner with resin-modified glass ionomer will be used over the pulpal floor before the composite placement in the control group. The longevity of restorative procedures and post-operative sensitivity were defined as the main and secondary outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Simplified restorative procedure | Experimental | Procedure: Restoration of carious lesionsAfter selective carious tissue removal, the universal adhesive (Adper Universal; 3M ESPE, St. Paul, MN, EUA) will be applied on the cavity walls. The cavity will be restored using a single increment of Filtek One Bulk Fill (3M ESPE, St. Paul, MN, EUA). |
| Control | Active comparator | Procedure: Restoration of carious lesionsA thin layer of resin-modified glass ionomer (Ionoseal (Voco America Inc., Briarcliff Manor, NY, EUA) will be placed on the pulpal floor of the cavity. Then, the adhesive and composite will be used following the same directions defined for the experimental condition. |
Who may qualify
- Ages
- 6 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Molar presenting deep carious lesion;
Key exclusion criteria (4 listed)
- Non-vital teeth or teeth presenting pulpitis;
- Cavity margins in dentin;
- Presence of non-carious cervical lesions;
- The necessity of restoration involving any cusp replacement.
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 |
|---|---|---|
| Restoration of carious lesionsSelective carious tissue removal followed by restoration of the cavity using composite resin. | Procedure or surgery | Control, Simplified restorative procedure |
Primary outcome
Longevity of restoration
Time frame: Annual evaluation during 5 years
Assessment of any failure in restorations according to the FDI World Dental Federation criteria.
1 secondary outcome
Tooth sensitivity
Time frame: 15 days after the restorative procedure
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 22 Jun 2023.
- 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.
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 Restoration of carious lesions in people with Caries; Dentin and Dental Restoration Failure of Marginal Integrity, run by Universidade Federal de Sergipe 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: withdrawn, as of the sponsor's last update on 22 Jun 2023. 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?
Longevity of restoration (time frame: Annual evaluation during 5 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 22 Jun 2023.