Non-carious Cervical LesionsNCT03637946
Release of Organic Components of a GIOMER in Non-carious Cervical Lesion Restorations
A study testing Device: SHOFU beautifil II LS in people with Non-carious Cervical Lesions, run by Federal University of Minas Gerais at 1 site in Brazil.
Trial summary
To evaluated the clinical performance of composite resin restorations, considering also the evaluation of release of resin components into saliva and the presence cytokines in gingival fluid. Restorative system FL-Bond II (self-etching adhesive system)/ beautifil II (composite restorative) were use. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-carious Cervical Lesions
- What is being tested?
- Device: SHOFU beautifil II LS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jun 2018to 1 Feb 2020
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Over 18 years of age; Systemically healthy; Non-smoking;
- With good oral hygiene;
- Absent irreversible pulpal alteration;
- With the presence of a non-carious cervical lesion (LCNCs) that needs to be restored. This lesion should be non-carious, non-retentive, with at least 1 mm and up to 3 mm depth, should involve both enamel and dentin of vital teeth without mobility, and present hypersensitivity;
- Presence a natural tooth of the same position of the restored tooth, but in the opposite arch of the same jaw to be considered for the positive control;
- Periodontal parameters : Depth Probing (PS), Visible Plaque Index (IPV), Gingival Index (GI) and Probing Bleed Index (SS). The normal included were: PS = 1 to 3 mm, GI = 0, IPV = score 0 e SS = score 0.
Who cannot join
- With severe systemic alteration;
- In the use of antibiotics and anti-inflammatories in the last three months;
- With periodontium with periodontal parameters different from those established in the inclusion criteria.
- Individuals with clinical signs of parafunctional habits;
- Smoking;
- Individuals who have performed other restorations in the last 12 months;
- Pregnant women and infants;
- Periodontal sites that presented bleeding during crevicular fluid collection or sites that prevent proper collection of clinical parameters.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Federal University Of Minas Gerais
Belo Horizonte, Minas Gerais, 31270-901
About this study
Official title: Release of Organic Components of a GIOMER in Non-carious Cervical Lesion Restorations: in Vitro and in Vivo Studies
To evaluated the clinical performance of composite resin restorations, considering also the evaluation of release of resin components into saliva and the presence cytokines in gingival fluid. Restorative system FL-Bond II (self-etching adhesive system)/ beautifil II (composite restorative) were use. For in vitro assays, adhesive and resin specimens are being preparing for assessing the monomers degree of conversion (by FTIR), sorption and solubility and release of resinous components in ethanol and Ringer solutions (through a gas chromatography and mass spectroscopy - GC-MS). In the longitudinal clinical study clinical performance of restorations and periodontal response were evaluate.
Read the detailed description
Release of components of a resin composite system containing pre-reagent vitreal particles: laboratory and patient studies. The objectives of this study was to evaluate physical and chemical properties of a methacrylate-based restorative system regarding to the release of resin components to the storage medium, to evaluate the clinical performance of composite resin restorations, considering also the evaluation of release of resin components into saliva and the presence of cytokines in gingival crevicular fluid. Restorative system FL-Bond II (self-etching adhesive system)/ beautifil II (composite restorative) were use. For in vitro assays, adhesive and resin specimens are being preparing for assessing the monomers degree of conversion (by FTIR), sorption and solubility and release of resinous components in ethanol and Ringer solutions (through a gas chromatography and mass spectroscopy - GC-MS). In the longitudinal clinical study, patients who present a NCCL with restorative need were selecting. Prior to treatment, there will be periodontal evaluation, saliva and gingival crevicular fluid collection (controls). The lesions were restoring with the restorative system. After 10 min,7 days, 1 and 6 months, clinical performance of restorations and periodontal response were evaluate according to the criterion FDI. Additionally, in all of these evaluation periods samples of saliva and crevicular fluid are being collecting. Saliva samples will be analyze by GC-MS to identify the eventual presence of organic components derived from the restoration. The crevicular fluid samples were analyzing using ELISA for identification and quantification of interleukins.
- Conditions
- Non-carious Cervical Lesions
- Being tested
- Device: SHOFU beautifil II LS
- Keywords
- Resin composite, clinical trial, biocompatibility, cytokines
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Device: SHOFU beautifil II LSOther
Restorative system FL-Bond II (self-etching adhesive system)/ beautifil II (composite restorative) were used following manufacturer's instructions
| Study group | Role | What they receive |
|---|---|---|
| SHOFU Beautifil II LS | Experimental | Experimental: SHOFU Beautifil II LS Restorative system FL-Bond II (self-etching adhesive system)/ Beautifil II (composite restorative) Receives: Other: Device: SHOFU beautifil II LS |
What is being measured
The primary outcome is the main question the study is designed to answer.
FDI criteria
The evaluation of the quality of the restoration will be evaluated using the FDI criteria and will be performed by two trained examiners at baseline and follow-up visits.The criteria has score given for each property with range from 1 to 5. Clinical assessments (Esthetic properties:surface brightness, surface and marginal color, color and translucency and anatomical form, Functional properties: marginal adaptation, fracture of material and retention, and Biological Properties: postoperative hypersensitivity, recurrence of caries, tooth integrity and adjacent mucosa)
Measured: Up to 6 months
Secondary outcomes (4)
Clinical parameters: visible plaque index (IPV)
registered presence (score 1) or absence (score 0) of bacterial plaque without the use of probe, after drying the dental surface with compressed air.
Measured: T1:One week before of starting treatment;T2: After 10 minutes of starting treatment;T3: After 1 week of starting treatment;T4: After 30 days of starting treatment;T5:After 6 months
Clinical parameters: probing depth (PS)
distance from the gingival margin to the fundus of the gingival sulcus or periodontal pocket, which will be measured by means of manual circumferential probing and measured on all the faces of the restored teeth and control;
Measured: T1:One week before of starting treatment;T2: After 10 minutes of starting treatment;T3: After 1 week of starting treatment;T4: After 30 days of starting treatment;T5:After 6 months;
Clinical parameters: probing bleeding (SS)
Bleeding to the Survey (SS): evaluated at the moment of PS measurement or until 30 to 60 seconds after the introduction of the probe with dichotomic values by presence (score 1) or absence (score 0)
Measured: T1:One week before of starting treatment;T2: After 10 minutes of starting treatment;T3: After 1 week of starting treatment;T4: After 30 days of starting treatment;T5:After 6 months
Clinical parameters: gingival index (GI)
evaluates the existence and severity of gingival lesions on a scale ranging from 0 to 3, where: 0: normal;
- mild inflammation with color change, mild edema, no bleeding at probing;
- moderate inflammation with red, shiny, swollen gingival tissue and presence of bleeding on probing;
- severe inflammation, with great increase of color and edema, ulceration and tendency to spontaneous bleeding.
Measured: T1:One week before of starting treatment;T2: After 10 minutes of starting treatment;T3: After 1 week of starting treatment;T4: After 30 days of starting treatment;T5:After 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2018
- Study start1 Jun 2018
- Primary completion1 Apr 2019
- Study completion1 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-carious Cervical LesionsStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single-center, non-blinded, clinical trial 6 months in duration.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Minas Gerais
- Sponsor type
- University, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Fundação de Amparo à Pesquisa do estado de Minas Gerais
- Responsible party
- Principal investigator, Tassiana Cançado Melo Sá, Federal University of Minas Gerais
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03637946
- Sponsor's protocol ID
- FUMinasGerais02
- Other IDs
- RBR-8m8cf2
- Status last verified
- Feb 2020
- First submitted
- 10 Aug 2018
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Release of Organic Components of a GIOMER in Non-carious Cervical Lesion Restorations: in Vitro and in Vivo Studies
- ClinicalTrials.gov ID
- NCT03637946
- Acronym / sponsor ID
- FUMinasGerais02
- Conditions
- Non-carious Cervical Lesions
- Keywords
- Resin composite, clinical trial, biocompatibility, cytokines
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Federal University of Minas GeraisUniversity, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Fundação de Amparo à Pesquisa do estado de Minas Gerais
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 1 Feb 2020 (actual)
- First posted
- 20 Aug 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.
To evaluated the clinical performance of composite resin restorations, considering also the evaluation of release of resin components into saliva and the presence cytokines in gingival fluid. Restorative system FL-Bond II (self-etching adhesive system)/ beautifil II (composite restorative) were use. For in vitro assays, adhesive and resin specimens are being preparing for assessing the monomers degree of conversion (by FTIR), sorption and solubility and release of resinous components in ethanol and Ringer solutions (through a gas chromatography and mass spectroscopy - GC-MS). In the longitudinal clinical study clinical performance of restorations and periodontal response were evaluate.
Detailed description
Release of components of a resin composite system containing pre-reagent vitreal particles: laboratory and patient studies. The objectives of this study was to evaluate physical and chemical properties of a methacrylate-based restorative system regarding to the release of resin components to the storage medium, to evaluate the clinical performance of composite resin restorations, considering also the evaluation of release of resin components into saliva and the presence of cytokines in gingival crevicular fluid. Restorative system FL-Bond II (self-etching adhesive system)/ beautifil II (composite restorative) were use. For in vitro assays, adhesive and resin specimens are being preparing for assessing the monomers degree of conversion (by FTIR), sorption and solubility and release of resinous components in ethanol and Ringer solutions (through a gas chromatography and mass spectroscopy - GC-MS). In the longitudinal clinical study, patients who present a NCCL with restorative need were selecting. Prior to treatment, there will be periodontal evaluation, saliva and gingival crevicular fluid collection (controls). The lesions were restoring with the restorative system. After 10 min,7 days, 1 and 6 months, clinical performance of restorations and periodontal response were evaluate according to the criterion FDI. Additionally, in all of these evaluation periods samples of saliva and crevicular fluid are being collecting. Saliva samples will be analyze by GC-MS to identify the eventual presence of organic components derived from the restoration. The crevicular fluid samples were analyzing using ELISA for identification and quantification of interleukins.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single-center, non-blinded, clinical trial 6 months in duration.
| Arm | Type | Receives |
|---|---|---|
| SHOFU Beautifil II LS | Experimental | Other: Device: SHOFU beautifil II LSExperimental: SHOFU Beautifil II LS Restorative system FL-Bond II (self-etching adhesive system)/ Beautifil II (composite restorative) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Over 18 years of age; Systemically healthy; Non-smoking;
- With good oral hygiene;
- Absent irreversible pulpal alteration;
- With the presence of a non-carious cervical lesion (LCNCs) that needs to be restored. This lesion should be non-carious, non-retentive, with at least 1 mm and up to 3 mm depth, should involve both enamel and dentin of vital teeth without mobility, and present hypersensitivity;
- Presence a natural tooth of the same position of the restored tooth, but in the opposite arch of the same jaw to be considered for the positive control;
Key exclusion criteria (8 listed)
- With severe systemic alteration;
- In the use of antibiotics and anti-inflammatories in the last three months;
- With periodontium with periodontal parameters different from those established in the inclusion criteria.
- Individuals with clinical signs of parafunctional habits;
- Smoking;
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 |
|---|---|---|
| Device: SHOFU beautifil II LSRestorative system FL-Bond II (self-etching adhesive system)/ beautifil II (composite restorative) were used following manufacturer's instructions | Other | SHOFU Beautifil II LS |
Primary outcome
FDI criteria
Time frame: Up to 6 months
The evaluation of the quality of the restoration will be evaluated using the FDI criteria and will be performed by two trained examiners at baseline and follow-up visits.The criteria has score given for each property with range from 1 to 5. Clinical assessments (Esthetic properties:surface brightness, surface and marginal color, color and translucency and anatomical form, Functional properties: marginal adaptation, fracture of material and retention, and Biological Properties: postoperative hypersensitivity, recurrence of caries, tooth integrity and adjacent mucosa)
4 secondary outcomes
Clinical parameters: visible plaque index (IPV)
Time frame: T1:One week before of starting treatment;T2: After 10 minutes of starting treatment;T3: After 1 week of starting treatment;T4: After 30 days of starting treatment;T5:After 6 months
Clinical parameters: probing depth (PS)
Time frame: T1:One week before of starting treatment;T2: After 10 minutes of starting treatment;T3: After 1 week of starting treatment;T4: After 30 days of starting treatment;T5:After 6 months;
Clinical parameters: probing bleeding (SS)
Time frame: T1:One week before of starting treatment;T2: After 10 minutes of starting treatment;T3: After 1 week of starting treatment;T4: After 30 days of starting treatment;T5:After 6 months
Clinical parameters: gingival index (GI)
Time frame: T1:One week before of starting treatment;T2: After 10 minutes of starting treatment;T3: After 1 week of starting treatment;T4: After 30 days of starting treatment;T5:After 6 months
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 5 Feb 2020.
- Individual participant dataSharing planned: No
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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 Device: SHOFU beautifil II LS in people with Non-carious Cervical Lesions, run by Federal University of Minas Gerais 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 6 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 5 Feb 2020. 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?
FDI criteria (time frame: Up to 6 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 5 Feb 2020.