Dental CariesNCT02389569
Clinical Study of Biosilicate Under Resin Composite Restorations in Caries Affected Teeth
A study testing Adhesive system and Restoration protocol in people with Dental Caries, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
This study aimed to evaluate the clinical performance of a novel vitro-ceramic biomaterial (Biosilicate®) as treatment of caries-affected dentin in posterior resin restorations. A total of 94 restorations of 66 participants were selected and assigned at random into four groups: 1 (Biosilicate / Two-step etch and rinse… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- Adhesive system and Restoration protocol
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteBrazil
- Study dates
- Start not givento 1 Aug 2016
- 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Cavitated or non-cavitated active carious lesions in dentin (Class I and/or II)
- Carious lesion in teeth with or without restoration in at least one tooth (upper or lower premolar and/or molar).
- No history of spontaneous pain
- Pulp vital tests positive
- No evidence of periapical radiolucency
Who cannot join
- Compromised medical history
- Periodontal disease
- Pulp necrosis
- Absence of antagonist teeth
- Severe bruxism
- Active orthodontic treatment
- Teeth with cracks and premature contact.
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Brazil1 site
University of Sao Paulo, Ribeirao Preto Campus
Ribeirão Preto, São Paulo, 14040-904
About this study
Official title: A Prospective, Double-blind, Randomized, Group Controlled Clinical Study on the Use of Biosilicate Under Resin Composite Restorations in Caries Affected Teeth
This study aimed to evaluate the clinical performance of a novel vitro-ceramic biomaterial (Biosilicate®) as treatment of caries-affected dentin in posterior resin restorations. A total of 94 restorations of 66 participants were selected and assigned at random into four groups: 1 (Biosilicate / Two-step etch and rinse system), 2 (Control / Two-step etch and rinse system), 3 (Biosilicate / Two-step self-etching system) and 4 (Control / Two-step self-etching system). Two operators carried out the adhesive protocols and restored the cavities with a nano-hybrid resin composite (IPS Empress, Ivoclar) using the incremental technique. Participants were recalled at one week, 6, 12 and 18 months for clinical evaluation performed by two blinders and calibrated examiners according FDI criteria.
Read the detailed description
Background: Dental caries has decreased in recent years, but is still the main oral health problem in developed and undeveloped industrialized countries. The purpose of this study is to evaluate clinical performance of resin-based composite Class I and II restorations in association with Biosilicate.
Methods: Eighty patients with carious lesions will be receive restorations in premolars and molars, which will be randomly allocated in four experimental groups: G1 (Biosilicate, AdperSingle Bond 2 and IPS Empress Direct composite), G2 (Adper Single Bond 2 and IPS Empress Direct composite), G3 (Biosilicate, AdheSe and IPS Empress Direct composite) e G4 (AdheSE and IPS Empress Direct composite) To participate in the clinical trial, qualified subjects must meet for inclusion and exclusion criteria. Sixty-four (64) selected volunteers will be fully informed on the nature of the study and after had signed a Term of Acceptance defined by the Ethics Committee (FORP - USP), they will be invited to participate.
Carious teeth will be cleaned with a pumice-water slurry and rubber cup to remove salivary pellicle and any bacterial plaque. As much as possible, local anesthesia will be. After caries removal (high and low-speed handpieces under abundant water irrigation), patients will be allocated randomly in the four experimental groups cited above. Final contouring and polishing of the restorations will be performed at the same appointment, using a fine-grit diamond bur (KG Sorensen), silicon carbide polisher (Viking Kit, KG Sorensen), silicone rubber tips (Viking Kit, KG Sorensen) flexible discs (Sof-Lex, 3M ESPE), and polishing pastes (Diamond Excel, FGM).
Two trained and calibrated evaluators, fully blinded to the restorative techniques used, will be evaluating the restorations at baseline (one week after placement of restorations), after 06, 12 and 18 months using FDI criteria. All restorations will be photographed at every evaluation point. Esthetic, Functional and Biological proprieties will be used as key parameters determining the overall clinical success. Data will be analyzed.
- Conditions
- Dental Caries
- Being tested
- Adhesive system, Restoration protocol
- Keywords
- Biomaterial, Dental caries, Composite
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adhesive systemProcedure or surgery
Also called Etch-and-rinse adhesive: Adper Single bond (3M, Brazil), Self-etch: Adhese (2 step self-etch) (Ivoclar, Vivadent)
Etch-and-rinse and Self-etch adhesive system will be applied in volunteers that received different types of restoration protocol.
Restoration protocolProcedure or surgery
Also called Biosilicate (Vitrovita, Brazil), Control
Volunteers will be treated by two types of protocol restoration : 1) Biosilicate (powder) or 2) Control (without Biosilicate). In sequence, adhesive (self-etch or etch and rinse) and composite resin will be used for restoration.
| Study group | Role | What they receive |
|---|---|---|
| Adhesive system treatment | Experimental | Four groups ( Two will be treat with Etch-and-Rinse Adhesive System and two will be treated with two step Self-Etch Adhesive System). Receives: Procedure: Adhesive system |
| Restoration protocol | Experimental | Four groups ( Two will be treat with experimental Biosilicate and two will be the control groups). Receives: Procedure: Restoration protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical performance of Biosilicate in caries lesion using FDI evaluation criteria
Two experienced and calibrated dentists, not involved with the placement of the restorations will be assess the efficiency of Biosilicate under composite restoration of Class I and Class II dentin caries lesions by record instrument to record the esthetic, functional and biological properties over a 18 months time frame. These variables will be ranked according to the FDI criteria in the following scores: clinically very good, clinically good, clinically sufficient/ satisfactory, clinically unsatisfactory and clinically poor.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2015 (estimated)
- Primary completion1 Aug 2016
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.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Universidade Federal de Sao Carlos
- Responsible party
- Principal investigator, Karen Pintado Palomino, University of Sao Paulo
- Investigators
- Karen Pintado Palomino, MSc, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02389569
- Sponsor's protocol ID
- CAAE nº: 27790214.1.0000.541
- Status last verified
- Apr 2017
- First submitted
- 24 Feb 2015
- Last updated
- 13 Apr 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Double-blind, Randomized, Group Controlled Clinical Study on the Use of Biosilicate Under Resin Composite Restorations in Caries Affected Teeth
- ClinicalTrials.gov ID
- NCT02389569
- Acronym / sponsor ID
- CAAE nº: 27790214.1.0000.541
- Conditions
- Dental Caries
- Keywords
- Biomaterial, Dental caries, Composite
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Universidade Federal de Sao Carlos
- Primary completion
- 1 Aug 2016 (actual)
- First posted
- 17 Mar 2015 (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.
This study aimed to evaluate the clinical performance of a novel vitro-ceramic biomaterial (Biosilicate®) as treatment of caries-affected dentin in posterior resin restorations. A total of 94 restorations of 66 participants were selected and assigned at random into four groups: 1 (Biosilicate / Two-step etch and rinse system), 2 (Control / Two-step etch and rinse system), 3 (Biosilicate / Two-step self-etching system) and 4 (Control / Two-step self-etching system). Two operators carried out the adhesive protocols and restored the cavities with a nano-hybrid resin composite (IPS Empress, Ivoclar) using the incremental technique. Participants were recalled at one week, 6, 12 and 18 months for clinical evaluation performed by two blinders and calibrated examiners according FDI criteria.
Detailed description
Background: Dental caries has decreased in recent years, but is still the main oral health problem in developed and undeveloped industrialized countries. The purpose of this study is to evaluate clinical performance of resin-based composite Class I and II restorations in association with Biosilicate.
Methods: Eighty patients with carious lesions will be receive restorations in premolars and molars, which will be randomly allocated in four experimental groups: G1 (Biosilicate, AdperSingle Bond 2 and IPS Empress Direct composite), G2 (Adper Single Bond 2 and IPS Empress Direct composite), G3 (Biosilicate, AdheSe and IPS Empress Direct composite) e G4 (AdheSE and IPS Empress Direct composite) To participate in the clinical trial, qualified subjects must meet for inclusion and exclusion criteria. Sixty-four (64) selected volunteers will be fully informed on the nature of the study and after had signed a Term of Acceptance defined by the Ethics Committee (FORP - USP), they will be invited to participate.
Carious teeth will be cleaned with a pumice-water slurry and rubber cup to remove salivary pellicle and any bacterial plaque. As much as possible, local anesthesia will be. After caries removal (high and low-speed handpieces under abundant water irrigation), patients will be allocated randomly in the four experimental groups cited above. Final contouring and polishing of the restorations will be performed at the same appointment, using a fine-grit diamond bur (KG Sorensen), silicon carbide polisher (Viking Kit, KG Sorensen), silicone rubber tips (Viking Kit, KG Sorensen) flexible discs (Sof-Lex, 3M ESPE), and polishing pastes (Diamond Excel, FGM).
Two trained and calibrated evaluators, fully blinded to the restorative techniques used, will be evaluating the restorations at baseline (one week after placement of restorations), after 06, 12 and 18 months using FDI criteria. All restorations will be photographed at every evaluation point. Esthetic, Functional and Biological proprieties will be used as key parameters determining the overall clinical success. Data will be analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adhesive system treatment | Experimental | Procedure: Adhesive systemFour groups ( Two will be treat with Etch-and-Rinse Adhesive System and two will be treated with two step Self-Etch Adhesive System). |
| Restoration protocol | Experimental | Procedure: Restoration protocolFour groups ( Two will be treat with experimental Biosilicate and two will be the control groups). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Cavitated or non-cavitated active carious lesions in dentin (Class I and/or II)
- Carious lesion in teeth with or without restoration in at least one tooth (upper or lower premolar and/or molar).
- No history of spontaneous pain
- Pulp vital tests positive
- No evidence of periapical radiolucency
Key exclusion criteria (8 listed)
- Compromised medical history
- Periodontal disease
- Pulp necrosis
- Absence of antagonist teeth
- Severe bruxism
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 |
|---|---|---|
| Adhesive systemAlso: Etch-and-rinse adhesive: Adper Single bond (3M, Brazil), Self-etch: Adhese (2 step self-etch) (Ivoclar, Vivadent)Etch-and-rinse and Self-etch adhesive system will be applied in volunteers that received different types of restoration protocol. | Procedure or surgery | Adhesive system treatment |
| Restoration protocolAlso: Biosilicate (Vitrovita, Brazil), ControlVolunteers will be treated by two types of protocol restoration : 1) Biosilicate (powder) or 2) Control (without Biosilicate). In sequence, adhesive (self-etch or etch and rinse) and composite resin will be used for restoration. | Procedure or surgery | Restoration protocol |
Primary outcome
Clinical performance of Biosilicate in caries lesion using FDI evaluation criteria
Time frame: 18 months
Two experienced and calibrated dentists, not involved with the placement of the restorations will be assess the efficiency of Biosilicate under composite restoration of Class I and Class II dentin caries lesions by record instrument to record the esthetic, functional and biological properties over a 18 months time frame. These variables will be ranked according to the FDI criteria in the following scores: clinically very good, clinically good, clinically sufficient/ satisfactory, clinically unsatisfactory and clinically poor.
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 13 Apr 2017.
- Dental School of Ribeirão Preto websiteLink provided by the sponsor.
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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.
Karen Pintado Palomino, MSc principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adhesive system and Restoration protocol in people with Dental Caries, run by University of Sao Paulo 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 8 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 13 Apr 2017. 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?
Clinical performance of Biosilicate in caries lesion using FDI evaluation criteria (time frame: 18 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 13 Apr 2017.