HealthyNCT05221242
Clinical Trial on Ceramic Partial Laminate Veneers With Different Luting Agents
A study testing Conventional Resin Cement vs Preheated Resin Composite in people with Healthy, run by Universidad Arturo Prat at 1 site in Chile.
Trial summary
Partial laminate veneers is a type of dental restoration made of a glass-matrix ceramic used to restore small teeth fractures, or to correct morphology defects of teeth (i.e.: diastema, conoid teeth or small misalignment). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Conventional Resin Cement vs Preheated Resin Composite
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChile
- Study dates
- 18 Apr 2024to 31 Jan 2025
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients over 18 years
- Patients able to read and sign an informed consent.
- Patients willing to come back to check-ups.
- Patients without active caries lesions or periodontal disease.
- Patients that need to restore their anterior maxillary teeth (upper incisors or canines) due to small fractures, misaligned teeth, conoid teeth or diastema.
- Non-vital teeth will also be included.
Who cannot join
- Patients with active caries lesions or periodontal disease.
- Patients with occlusal disfunction or uncontrolled parafunctional habits.
- Patients unwilling to come back to checkups.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Split-mouth Clinical Trial of Partial Laminate Veneers Bonded With Two Different Resin Composite Luting Agents
Partial laminate veneers is a type of dental restoration made of a glass-matrix ceramic used to restore small teeth fractures, or to correct morphology defects of teeth (i.e.: diastema, conoid teeth or small misalignment). As tooth surface reduction, or tooth preparation is not needed for this type of restoration, it can be considered as a non-tooth preparation minimally invasive procedure.
As non-preparation is required for the restoration with ceramic partial laminate veneers, bonding relies on adhesion between the intaglio surface of the ceramic restoration and the tooth surface, which in most of the cases is enamel. For this purpose, many light-curing resin cement materials are available for bonding procedures. Nowadays, pre-heated resin composites are available as a resin luting material which has been indicated for laminate veneers and partial indirect posterior restorations.
As pre-heated resin composite has not been yet studied for partial laminate veneers, the objective of this randomized split mouth clinical trial, is to evaluate the survival of ceramic partial laminate veneers when bonded with two different resin composite luting agents.
Read the detailed description
Patients will be recruited starting the 18th of April 2024. Patients willing to enroll in this study must be over 18 years old, capable to read and sign an informed consent, willing to come back to checkups, with periodontal and pulpal health, having anterior teeth with the need of minimal morphology corrections like diastema, conoid teeth or misaligned teeth, and small fractures. Non vital teeth were not excluded. Patients will poor oral hygiene, active caries lesions are excluded.
Pre Operative Procedures. Informed consent will be given first and ask for every patient to sign it. Face and intraoral photographs will be taken. Initial polyvinylsiloxane (PVS) impressions will be performed and sent to the dental laboratory for wax-up from a digital planning analysis. Prophylaxis, new restorations, endodontic treatment and gingival surgery will be performed based on a mock-up made from bis-acrylic material.
Tooth preparation Most cases won't have tooth surface reduction or preparation. Some cases will need smoothening of the sharp angles or enamel irregularities to prevent fractures during restoration try-in. New impression will be performed with PVS impression material to obtain working models for the elaboration of ceramic partial laminate veneers (PLV) One dental technician will elaborate all the PLV according to the manufacturer instructions.
Adhesive luting procedures. Seating, adaptation and form will be checked firt. Try-in pastes will be used to control shade match of the restorations that will be adhesively luted with Variolink Esthetic (conventional light-curing resin cement), while polarized photography of a small amount of polymerized resin composite will be taken for color selection of the preheated resin composite luting agent (Enamel Plus HFO).
Intaglio surfaces of the ceramic restorations protocol:
- - Application of 9,5% hydrofluoric acid for 120 seconds.
- - 1 minute of water rinsing. 5 minutes of ultrasonic bath cleaning with distilled water.
- - Silane application
- - Bonding Application (without light-curing):
- Optibond Fl adhesive for ceramics that will be bonded with Enamel Plus HFO.
- - Charge of resin cement (without light-curing)
- Variolink esthetic according to color try-in.
- Enamel Plus HFO will be pre heated in a resin heater at 69ºC.
- - Store the restorations of light exposure.
Surface treatment of enamel and dentin (if dentin is exposed):
- - Apply phosphoric acid for 15 seconds in enamel.
- - rinse profusely with water for 30 seconds.
- - air-dry
- - apply adhesive on tooth surface.
- - No light-curing.
Restorations will be seated with small finger pressure, excesses of resin cement will be eliminated using brushes. Light-curing will be then performed using soft mode of approximately 650mw/cm2 during 3-5 seconds. A final light-curing in high mode will be performed after 3-5 minutes of waiting at approximately 1200 mw/cm2.
Polishing procedure All restorations will be polished with 2-step diamond spiral wheels under water irrigation.
Evaluation 2 blind observers to the luting procedure performed will evaluate clinically the restorations using the modified USPHS criteria and the FDI (World Dental Federation) criteria for the evaluation of direct and indirect restorations. Also an Impact in Oral Health questionary will be applied to determine the esthetic perception of the applied treatment.
modified USPHS criteria and FDI criteria will be applied at baseline after luting the restorations and every 6 months until a completion of minimum of 24 months.
Impact in Oral Health questionary will be applied at baseline and 6 months after the treatment.
Scanning Electron Microscopy evaluation Every case will receive final impressions immediately after the treatment, and after 24 months to evaluate marginal adaptation under Scanning electron microscopy. Fractography Analysis will be performed of every failure or fracture of the restoration.
Statistical analysis Survival will be measure in percentages. Differences will be measure between baseline and final control.
Kaplan-Meier curves will be used to measure cumulative survival, and log rank (Mantel-Cox) to determine differences between the two groups (bonded with conventional resin cement vs pre heated resin composite)
- Conditions
- Healthy
- Being tested
- Conventional Resin Cement vs Preheated Resin Composite
- Keywords
- partial laminate veneers, sectional veneers, ceramic fragments
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Resin Cement vs Preheated Resin CompositeProcedure or surgery
Also called Variolink Esthetic (Ivoclar Vivadent, Schaan, Liechtenstein), Enamel Plus HFO (Micerium, Avegno, Italy)
For this study, variolink esthetic resin cement will be used to bond ceramic partial laminate veneers in one side of the maxillary anterior teeth (left or right upper incisors and canines), while, the other side will receive ceramic partial laminate veneers bonded with a preheated resin composite
| Study group | Role | What they receive |
|---|---|---|
| Patients with PLV | Experimental | All patients will receive ceramic partial laminate veneers as treatment. As this is a split mouth design, one side of the mouth will receive partial laminate veneers bonded with a conventional light-curing resin cement and the other side of the mouth with a pre-heated resin composite. Receives: Procedure: Conventional Resin Cement vs Preheated Resin Composite |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival Data of Partial Laminate Veneers bonded with Conventional Resin Cement and Preheated Resin Composite
Survival data will be measured in percentages (0-100%) over the years. Kaplan - Meier curves are used to determine the moment of failure (date, months) Mantel - Cox test will be used to determine differences between the two groups
Measured: after 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2022
- Study start18 Apr 2024
- Primary completion31 Jan 2025 (estimated)
- Study completion31 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- In this study, two different luting resin cements will be used to bond ceramic partial laminate veneers. This is a randomized split mouth clinical trial, in which only maxillary anterior teeth will be treated with partial veneers (maximum 6 teeth, upper incisors and canines. This zone is called sector 2). For this purpose, sector 2 will be divided in two sides (right and left), and randomization will be performed to select a conventional resin cement or a preheated resin composite luting agent as the material of choice for the right or left side of the mouth to bond ceramic partial laminate veneers for every recruited patient. Number of participants is related to the number of restorations.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Arturo Prat
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad de Concepcion
- Responsible party
- Principal investigator, Gerardo Duran Ojeda, Universidad Arturo Prat
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05221242
- Sponsor's protocol ID
- 06-07-10-2021
- Status last verified
- Jun 2024
- First submitted
- 10 Jan 2022
- Last updated
- 1 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The information of patients will be private and not shared. Only researchers included in the Study will be authorized to access patient's data. Blind observers won't be able to access patients data to reduce bias.
Publications
Gresnigt MM, Kalk W, Ozcan M. Randomized controlled split-mouth clinical trial of direct laminate veneers with two micro-hybrid resin composites. J Dent. 2012 Sep;40(9):766-75. doi: 10.1016/j.jdent.2012.05.010. Epub 2012 Jun 2.
PubMed 22664565Sinhori BS, Monteiro S Jr, Bernardon JK, Baratieri LN. CAD/CAM ceramic fragments in anterior teeth: A clinical report. J Esthet Restor Dent. 2018 Mar;30(2):96-100. doi: 10.1111/jerd.12342. Epub 2017 Sep 28.
PubMed 28960775Gresnigt MMM, Sugii MM, Johanns KBFW, van der Made SAM. Comparison of conventional ceramic laminate veneers, partial laminate veneers and direct composite resin restorations in fracture strength after aging. J Mech Behav Biomed Mater. 2021 Feb;114:104172. doi: 10.1016/j.jmbbm.2020.104172. Epub 2020 Nov 4.
PubMed 33172798Ceinos R, Pouyssegur V, Allard Y, Bertrand MF. Esthetic rehabilitation of the smile with partial laminate veneers in an older adult. Clin Case Rep. 2018 Jun 4;6(8):1407-1411. doi: 10.1002/ccr3.1593. eCollection 2018 Aug.
PubMed 30147872Elter B, Aladag A, Comlekoglu ME, Dundar Comlekoglu M, Kesercioglu AI. Colour stability of sectional laminate veneers: A laboratory study. Aust Dent J. 2021 Sep;66(3):314-323. doi: 10.1111/adj.12837. Epub 2021 Apr 7.
PubMed 33721347Signore A, Kaitsas V, Tonoli A, Angiero F, Silvestrini-Biavati A, Benedicenti S. Sectional porcelain veneers for a maxillary midline diastema closure: a case report. Quintessence Int. 2013 Mar;44(3):201-6. doi: 10.3290/j.qi.a29058.
PubMed 23444201Gresnigt M, Ozcan M. Esthetic rehabilitation of anterior teeth with porcelain laminates and sectional veneers. J Can Dent Assoc. 2011;77:b143.
PubMed 22067068Farias-Neto A, Gomes EM, Sanchez-Ayala A, Sanchez-Ayala A, Vilanova LS. Esthetic Rehabilitation of the Smile with No-Prep Porcelain Laminates and Partial Veneers. Case Rep Dent. 2015;2015:452765. doi: 10.1155/2015/452765. Epub 2015 Oct 18.
PubMed 26568893Horvath S, Schulz CP. Minimally invasive restoration of a maxillary central incisor with a partial veneer. Eur J Esthet Dent. 2012 Spring;7(1):6-16.
PubMed 22319761
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Split-mouth Clinical Trial of Partial Laminate Veneers Bonded With Two Different Resin Composite Luting Agents
- ClinicalTrials.gov ID
- NCT05221242
- Acronym / sponsor ID
- 06-07-10-2021
- Conditions
- Healthy
- Keywords
- partial laminate veneers, sectional veneers, ceramic fragments
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universidad Arturo PratUniversity, hospital or other
- Collaborators
- Universidad de Concepcion
- Study start
- 18 Apr 2024 (actual)
- Primary completion
- 31 Jan 2025 (estimated)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 2 Feb 2022 (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.
Partial laminate veneers is a type of dental restoration made of a glass-matrix ceramic used to restore small teeth fractures, or to correct morphology defects of teeth (i.e.: diastema, conoid teeth or small misalignment). As tooth surface reduction, or tooth preparation is not needed for this type of restoration, it can be considered as a non-tooth preparation minimally invasive procedure.
As non-preparation is required for the restoration with ceramic partial laminate veneers, bonding relies on adhesion between the intaglio surface of the ceramic restoration and the tooth surface, which in most of the cases is enamel. For this purpose, many light-curing resin cement materials are available for bonding procedures. Nowadays, pre-heated resin composites are available as a resin luting material which has been indicated for laminate veneers and partial indirect posterior restorations.
As pre-heated resin composite has not been yet studied for partial laminate veneers, the objective of this randomized split mouth clinical trial, is to evaluate the survival of ceramic partial laminate veneers when bonded with two different resin composite luting agents.
Detailed description
Patients will be recruited starting the 18th of April 2024. Patients willing to enroll in this study must be over 18 years old, capable to read and sign an informed consent, willing to come back to checkups, with periodontal and pulpal health, having anterior teeth with the need of minimal morphology corrections like diastema, conoid teeth or misaligned teeth, and small fractures. Non vital teeth were not excluded. Patients will poor oral hygiene, active caries lesions are excluded.
Pre Operative Procedures. Informed consent will be given first and ask for every patient to sign it. Face and intraoral photographs will be taken. Initial polyvinylsiloxane (PVS) impressions will be performed and sent to the dental laboratory for wax-up from a digital planning analysis. Prophylaxis, new restorations, endodontic treatment and gingival surgery will be performed based on a mock-up made from bis-acrylic material.
Tooth preparation Most cases won't have tooth surface reduction or preparation. Some cases will need smoothening of the sharp angles or enamel irregularities to prevent fractures during restoration try-in. New impression will be performed with PVS impression material to obtain working models for the elaboration of ceramic partial laminate veneers (PLV) One dental technician will elaborate all the PLV according to the manufacturer instructions.
Adhesive luting procedures. Seating, adaptation and form will be checked firt. Try-in pastes will be used to control shade match of the restorations that will be adhesively luted with Variolink Esthetic (conventional light-curing resin cement), while polarized photography of a small amount of polymerized resin composite will be taken for color selection of the preheated resin composite luting agent (Enamel Plus HFO).
Intaglio surfaces of the ceramic restorations protocol:
- - Application of 9,5% hydrofluoric acid for 120 seconds.
- - 1 minute of water rinsing. 5 minutes of ultrasonic bath cleaning with distilled water.
- - Silane application
- - Bonding Application (without light-curing):
- Optibond Fl adhesive for ceramics that will be bonded with Enamel Plus HFO.
- - Charge of resin cement (without light-curing)
- Variolink esthetic according to color try-in.
- Enamel Plus HFO will be pre heated in a resin heater at 69ºC.
- - Store the restorations of light exposure.
Surface treatment of enamel and dentin (if dentin is exposed):
- - Apply phosphoric acid for 15 seconds in enamel.
- - rinse profusely with water for 30 seconds.
- - air-dry
- - apply adhesive on tooth surface.
- - No light-curing.
Restorations will be seated with small finger pressure, excesses of resin cement will be eliminated using brushes. Light-curing will be then performed using soft mode of approximately 650mw/cm2 during 3-5 seconds. A final light-curing in high mode will be performed after 3-5 minutes of waiting at approximately 1200 mw/cm2.
Polishing procedure All restorations will be polished with 2-step diamond spiral wheels under water irrigation.
Evaluation 2 blind observers to the luting procedure performed will evaluate clinically the restorations using the modified USPHS criteria and the FDI (World Dental Federation) criteria for the evaluation of direct and indirect restorations. Also an Impact in Oral Health questionary will be applied to determine the esthetic perception of the applied treatment.
modified USPHS criteria and FDI criteria will be applied at baseline after luting the restorations and every 6 months until a completion of minimum of 24 months.
Impact in Oral Health questionary will be applied at baseline and 6 months after the treatment.
Scanning Electron Microscopy evaluation Every case will receive final impressions immediately after the treatment, and after 24 months to evaluate marginal adaptation under Scanning electron microscopy. Fractography Analysis will be performed of every failure or fracture of the restoration.
Statistical analysis Survival will be measure in percentages. Differences will be measure between baseline and final control.
Kaplan-Meier curves will be used to measure cumulative survival, and log rank (Mantel-Cox) to determine differences between the two groups (bonded with conventional resin cement vs pre heated resin composite)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- In this study, two different luting resin cements will be used to bond ceramic partial laminate veneers. This is a randomized split mouth clinical trial, in which only maxillary anterior teeth will be treated with partial veneers (maximum 6 teeth, upper incisors and canines. This zone is called sector 2). For this purpose, sector 2 will be divided in two sides (right and left), and randomization will be performed to select a conventional resin cement or a preheated resin composite luting agent as the material of choice for the right or left side of the mouth to bond ceramic partial laminate veneers for every recruited patient. Number of participants is related to the number of restorations.
| Arm | Type | Receives |
|---|---|---|
| Patients with PLV | Experimental | Procedure: Conventional Resin Cement vs Preheated Resin CompositeAll patients will receive ceramic partial laminate veneers as treatment. As this is a split mouth design, one side of the mouth will receive partial laminate veneers bonded with a conventional light-curing resin cement and the other side of the mouth with a pre-heated resin composite. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients over 18 years
- Patients able to read and sign an informed consent.
- Patients willing to come back to check-ups.
- Patients without active caries lesions or periodontal disease.
- Patients that need to restore their anterior maxillary teeth (upper incisors or canines) due to small fractures, misaligned teeth, conoid teeth or diastema.
Key exclusion criteria (3 listed)
- Patients with active caries lesions or periodontal disease.
- Patients with occlusal disfunction or uncontrolled parafunctional habits.
- Patients unwilling to come back to checkups.
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 |
|---|---|---|
| Conventional Resin Cement vs Preheated Resin CompositeAlso: Variolink Esthetic (Ivoclar Vivadent, Schaan, Liechtenstein), Enamel Plus HFO (Micerium, Avegno, Italy)For this study, variolink esthetic resin cement will be used to bond ceramic partial laminate veneers in one side of the maxillary anterior teeth (left or right upper incisors and canines), while, the other side will receive ceramic partial laminate veneers bonded with a preheated resin composite | Procedure or surgery | Patients with PLV |
Primary outcome
Survival Data of Partial Laminate Veneers bonded with Conventional Resin Cement and Preheated Resin Composite
Time frame: after 36 months
Survival data will be measured in percentages (0-100%) over the years. Kaplan - Meier curves are used to determine the moment of failure (date, months) Mantel - Cox test will be used to determine differences between the two groups
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2024.
- Background: PubMed 22664565Gresnigt MM, Kalk W, Ozcan M. Randomized controlled split-mouth clinical trial of direct laminate veneers with two micro-hybrid resin composites. J Dent. 2012 Sep;40(9):766-75. doi: 10.1016/j.jdent.2012.05.010. Epub 2012 Jun 2.
- Background: PubMed 28960775Sinhori BS, Monteiro S Jr, Bernardon JK, Baratieri LN. CAD/CAM ceramic fragments in anterior teeth: A clinical report. J Esthet Restor Dent. 2018 Mar;30(2):96-100. doi: 10.1111/jerd.12342. Epub 2017 Sep 28.
- Background: PubMed 33172798Gresnigt MMM, Sugii MM, Johanns KBFW, van der Made SAM. Comparison of conventional ceramic laminate veneers, partial laminate veneers and direct composite resin restorations in fracture strength after aging. J Mech Behav Biomed Mater. 2021 Feb;114:104172. doi: 10.1016/j.jmbbm.2020.104172. Epub 2020 Nov 4.
- Background: PubMed 30147872Ceinos R, Pouyssegur V, Allard Y, Bertrand MF. Esthetic rehabilitation of the smile with partial laminate veneers in an older adult. Clin Case Rep. 2018 Jun 4;6(8):1407-1411. doi: 10.1002/ccr3.1593. eCollection 2018 Aug.
- Background: PubMed 33721347Elter B, Aladag A, Comlekoglu ME, Dundar Comlekoglu M, Kesercioglu AI. Colour stability of sectional laminate veneers: A laboratory study. Aust Dent J. 2021 Sep;66(3):314-323. doi: 10.1111/adj.12837. Epub 2021 Apr 7.
- Background: PubMed 23444201Signore A, Kaitsas V, Tonoli A, Angiero F, Silvestrini-Biavati A, Benedicenti S. Sectional porcelain veneers for a maxillary midline diastema closure: a case report. Quintessence Int. 2013 Mar;44(3):201-6. doi: 10.3290/j.qi.a29058.
- Background: PubMed 22067068Gresnigt M, Ozcan M. Esthetic rehabilitation of anterior teeth with porcelain laminates and sectional veneers. J Can Dent Assoc. 2011;77:b143.
- Background: PubMed 26568893Farias-Neto A, Gomes EM, Sanchez-Ayala A, Sanchez-Ayala A, Vilanova LS. Esthetic Rehabilitation of the Smile with No-Prep Porcelain Laminates and Partial Veneers. Case Rep Dent. 2015;2015:452765. doi: 10.1155/2015/452765. Epub 2015 Oct 18.
- Background: PubMed 22319761Horvath S, Schulz CP. Minimally invasive restoration of a maxillary central incisor with a partial veneer. Eur J Esthet Dent. 2012 Spring;7(1):6-16.
- Individual participant dataSharing planned: No. The information of patients will be private and not shared. Only researchers included in the Study will be authorized to access patient's data. Blind observers won't be able to access patients data to reduce bias.
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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 Conventional Resin Cement vs Preheated Resin Composite in people with Healthy, run by Universidad Arturo Prat at 1 site in Chile.
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 3 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 1 Jul 2024. 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 Chile. 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?
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 Data of Partial Laminate Veneers bonded with Conventional Resin Cement and Preheated Resin Composite (time frame: after 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05221242, which also lists 9 linked publications.
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 Jul 2024.