Dental DiseasesNCT05998980
6-year Clinical Performance of Prefabricated and Composite Veneers ( Componeer)
A study testing Componeer prefabricated veneers and Essentia resin composite veneers in people with Dental Diseases and Tooth Discoloration, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to compare the clinical performance of composite veneers performed in two different ways, indirect and direct methods over a period of 6-year. 30 volunteer patients without systemic diseases and who applied to Ege University School of Dentistry for the esthetic restoration of their anterior… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Diseases, Tooth Discoloration
- What is being tested?
- Componeer prefabricated veneers and Essentia resin composite veneers
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2016to 15 Jan 2017
- 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
- Being healthy without any chronic disease
- Having diastema in the anterior teeth without any caries
- Not having an occlusal anomaly such as bruxism or anterior crossbite
- Having a good oral hygiene
- Agreeing to come to the recall sessions regularly for 6 years
- Being over the age of 18
Who cannot join
- Having uncontrolled parafunction such as bruxism or anterior deep bite
- Having insufficient oral hygiene
- Being pregnant
- Having a systemic disease
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ege University School of Dentistry Department of Restorative
Izmir, Bornova, 35040
About this study
Official title: Clinical Comparison of Prefabricated Resin Composite Veneers and Direct Resin Composite Veneers Over 6-years
The aim of this study is to compare the clinical performance of composite veneers performed in two different ways, indirect and direct methods over a period of 6-year.
30 volunteer patients without systemic diseases and who applied to Ege University School of Dentistry for the esthetic restoration of their anterior diastema (gap) were selected according to inclusion and exclusion criteria. The closure of 102 diastema was randomly performed with prefabricated composite resin veneers (n=15; indirect method- Componeer, Coltène, Altstätten, Switzerland) or direct composite resin veneers (n=15; direct method- Essentia, GC, Japan). These restorations were clinically evaluated at baseline, 1-2-6-year by two experienced and blind examiners according to modified Ryge criteria (USPHS criteria). Color match, marginal discoloration, anatomic form, marginal adaptation, secondary caries, surface roughness, retention, and polishing retention were evaluated for that purpose. Statistical analysis was performed with McNemar and Chi-square tests (p<0.05).
Read the detailed description
The aim of this study is to compare the clinical performance of composite veneers performed in two different ways, indirect (Componeer) and direct methods (Essentia) over a period of 6-year.
The study protocol was approved by the Ethical Committee of Ege University, Izmir, Turkey (16-2.1/8; 01.04.2016). 30 patients without any systemic diseases (10 males, 20 females, mean age: 34) and with aesthetic complaints on their anterior teeth were treated with 102 restorations (48 Componeer and 54 Essentia).
In Group 1; 48 teeth (15 patients) were restored with Componeer prefabricated veneers (Coltène, Altstätten, Switzerland) in combination with Synergy D6 nanohybrid resin composite (Coltène) and One Coat Bond (Coltène) adhesive system. In Group 2; 54 teeth (15 patients) were restored with Essentia (GC, Japan) micro-hybrid resin composite in combination with G-Premio Bond (GC) adhesive system.
Periodontal treatments, fillings, and bleaching treatments were performed, if necessary, before any veneer treatment. For the pre-treatment records; 3 photographs (smile, anterior occlusion, and upper anterior teeth alone) were taken from each patient. Both groups used the "Button Try" technique for color selection. Componeer sizing guide was used for size selection in Group 1. Then teeth were cleaned with non-fluoride pumice (Cleanic; Kerr Dental, ABD) using a polishing brush. Isolation of the teeth and retraction of the lips were achieved with a rubber dam (OptraDam, Ivoclar Vivadent, Liechtenstein). Prefabricated veneers were prepared for the cementation process in Group 1. Then the labial surfaces were etched using 36% phosphoric acid for 30 s. The etched surfaces were rinsed for 30 s and dried. One Coat Bond (Coltene) adhesive system was applied on the labial surfaces of the teeth in accordance with user instructions in both groups. In Group 1; Synergy D6 nano hybrid resin composite was placed on the inner surfaces of the prefabricated veneers before being applied on appropriate teeth. Then the restorations were light-cured for 40 s from each surface (D-Light Pro, GC) and polished with a polishing paste (Prisma Gloss Extra Fine, Dentsply, NY, ABD) and a felt wheel.
In Group 2; Essentia (GC) micro-hybrid resin composite with dentin color was placed on the labial surfaces of the teeth and light-cured (D-Light Pro, GC). After that layer, Essentia enamel shades were placed over the labial surface of the tooth and light-cured for 20 s from each surface. The diamond bur contouring was performed and polishing discs (Super-Snap Rainbow Technique Kit, SHOFU) were used. For polishing purposes, a polishing paste (Prisma Gloss Extra Fine, Dentsply, NY, ABD) and a felt Wheel were used.
In group 1; gingival borders were adapted with contouring and polishing discs (Super-Snap Rainbow Technique Kit, SHOFU). Then proximal surfaces were polished using proximal sandpaper strips. Occlusion was checked for premature contacts. Two calibrated observers who were blinded to the objective of this study performed the evaluations. Color match, marginal adaptation, marginal discoloration, anatomic form, retention, secondary caries, and gloss retention were the properties evaluated for the restorations at baseline, 1-2-6-year using Modified Ryge Criteria (USPHS Criteria). Statistical analysis was performed with McNemar and Chi-square tests (p<0.05).
- Conditions
- Dental Diseases, Tooth Discoloration
- Being tested
- Componeer prefabricated veneers, Essentia resin composite veneers
- Keywords
- veneers, prefabricated veneers, anterior restorations
- Medical subject headings
- Stomatognathic Diseases, Tooth Discoloration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Componeer prefabricated veneersProcedure or surgery
Individual Randomized Clinical Trial
Essentia resin composite veneersProcedure or surgery
Individual Randomized Clinical Trial
| Study group | Role | What they receive |
|---|---|---|
| Componeer Prefabricated Veneers | Active comparator | Componeer veneers (device 1) were randomly applied to patients. The teeth were evaluated in terms of color and size matching in order to select the correct veneers. Componeer sizing guide was used for size selection. Prefabricated veneers were adapted to the teeth' surfaces. Then, the inner surfaces of the prefabricated veneers were roughened to obtain better mechanical retention. Then the labial surfaces of the teeth were etched using 36% phosphoric acid. The etched surfaces were rinsed and dried. An adhesive system was applied to the teeth. Prefabricated veneers' inner surfaces were cleaned with alcohol, and One Coat dental adhesive was applied. Synergy D6 nanohybrid resin composite was placed on the inner surfaces of the veneers and transferred to the teeth. The restorations were light-cured for 40 s Gingival borders were adapted with contouring and polishing discs (intervention 1). Receives: Procedure: Componeer prefabricated veneers |
| Essentia resin composite venners | Active comparator | Direct resin composite restorations were randomly applied to patients. Essentia resin composite (device 2) shade guide was used for color selection. After the preparation, the labial surfaces of the teeth were etched using 36% phosphoric acid. The etched surfaces were then rinsed and dried. An adhesive system G-Premio Bond was applied to the teeth. Then Essentia micro-hybrid resin composite with dentin shade was placed on labial surfaces of teeth and was light-cured. Then enamel shade was placed on the tooth. After that, the resin composite veneer was light-cured for 20 s from each surface. Proximal surfaces were polished using proximal sandpaper strips (intervention 2). Receives: Procedure: Essentia resin composite veneers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Marginal discoloration
Marginal discoloration of prefabricated and resin composite veneers Evaluating differently veneer options on anterior teeth with United State Public Health Service criteria regarding marginal discoloration by 2 independent evaluators Marginal discolouration was evaluated by 2 independent clinicians. Visual inspection with a mirror at 18 inches was performed. A score means the higher score of clinical acceptability while C score means that the restoration has failed and needs to be replaced.
Alpha: No discoloration anywhere along the margin between the restoration and the adjacent tooth. Bravo: Slight discoloration along the margin between the restoration and the adjacent tooth.
Charlie: The discoloration penetrated along the margin of the restorative material in a pulpal direction.
Measured: 6 years
Marginal adaptation
Marginal adaptation of prefabricated and resin composite veneers Evaluating differently veneer options on anterior teeth with United State Public Health Service criteria regarding marginal adaptation by 2 independent evaluators Marginal discolouration was evaluated by 2 independent clinicians. Visual inspection with a mirror at 18 inches was performed . A score means the higher score of clinical acceptability while C score means that the restoration has failed and needs to be replaced.
Alpha: No discoloration anywhere along the margin between the restoration and the adjacent tooth. Bravo: Slight discoloration along the margin between the restoration and the adjacent tooth.
Charlie: The discoloration penetrated along the margin of the restorative material in a pulpal direction.
Measured: 6 years
Retention rate
Retention rates of prefabricated and resin composite veneers Evaluating differently veneer options on anterior teeth with United State Public Health Service criteria regarding retention rates by 2 independent evaluators Marginal discolouration was evaluated by 2 independent clinicians. Visual inspection with a mirror at 18 inches was performed . A score means the higher score of clinical acceptability while C score means that the restoration has failed and needs to be replaced.
Alpha: No discoloration anywhere along the margin between the restoration and the adjacent tooth. Bravo: Slight discoloration along the margin between the restoration and the adjacent tooth.
Charlie: The discoloration penetrated along the margin of the restorative material in a pulpal direction.
Measured: 6 years
Anatomic form
Anatomic form of prefabricated and resin composite veneers Evaluating differently veneer options on anterior teeth with United State Public Health Service criteria regarding anatomic form by 2 independent evaluators Marginal discolouration was evaluated by 2 independent clinicians. Visual inspection with a mirror at 18 inches was performed. A score means the higher score of clinical acceptability while C score means that the restoration has failed and needs to be replaced.
Alpha: No discoloration anywhere along the margin between the restoration and the adjacent tooth. Bravo: Slight discoloration along the margin between the restoration and the adjacent tooth.
Charlie: The discoloration penetrated along the margin of the restorative material in a pulpal direction.
Measured: 6 years
Color match
Color changes of prefabricated and resin composite veneers Health Service criteria regarding color changes by 2 independent evaluators Marginal discolouration was evaluated by 2 independent clinicians. Visual inspection with a mirror at 18 inches was performed . A score means the higher score of clinical acceptability while C score means that the restoration has failed and needs to be replaced.
Alpha: No discoloration anywhere along the margin between the restoration and the adjacent tooth. Bravo: Slight discoloration along the margin between the restoration and the adjacent tooth.
Charlie: The discoloration penetrated along the margin of the restorative material in a pulpal direction
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start1 Jul 2016
- Primary completion30 Dec 2016
- Study completion15 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental DiseasesStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe 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
- Parallel groups
- Model description
- Individual Randomized Assignment
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sebnem Turkun, Ege University
- Investigators
- Sebnem L Turkun, DDS,PhD, Study director, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05998980
- Sponsor's protocol ID
- 16-2.1/8
- Status last verified
- Aug 2023
- First submitted
- 11 Aug 2023
- Last updated
- 21 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Comparison of Prefabricated Resin Composite Veneers and Direct Resin Composite Veneers Over 6-years
- ClinicalTrials.gov ID
- NCT05998980
- Acronym / sponsor ID
- 16-2.1/8
- Conditions
- Dental Diseases, Tooth Discoloration
- Keywords
- veneers, prefabricated veneers, anterior restorations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 30 Dec 2016 (actual)
- Study completion
- 15 Jan 2017 (actual)
- First posted
- 21 Aug 2023 (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 aim of this study is to compare the clinical performance of composite veneers performed in two different ways, indirect and direct methods over a period of 6-year.
30 volunteer patients without systemic diseases and who applied to Ege University School of Dentistry for the esthetic restoration of their anterior diastema (gap) were selected according to inclusion and exclusion criteria. The closure of 102 diastema was randomly performed with prefabricated composite resin veneers (n=15; indirect method- Componeer, Coltène, Altstätten, Switzerland) or direct composite resin veneers (n=15; direct method- Essentia, GC, Japan). These restorations were clinically evaluated at baseline, 1-2-6-year by two experienced and blind examiners according to modified Ryge criteria (USPHS criteria). Color match, marginal discoloration, anatomic form, marginal adaptation, secondary caries, surface roughness, retention, and polishing retention were evaluated for that purpose. Statistical analysis was performed with McNemar and Chi-square tests (p<0.05).
Detailed description
The aim of this study is to compare the clinical performance of composite veneers performed in two different ways, indirect (Componeer) and direct methods (Essentia) over a period of 6-year.
The study protocol was approved by the Ethical Committee of Ege University, Izmir, Turkey (16-2.1/8; 01.04.2016). 30 patients without any systemic diseases (10 males, 20 females, mean age: 34) and with aesthetic complaints on their anterior teeth were treated with 102 restorations (48 Componeer and 54 Essentia).
In Group 1; 48 teeth (15 patients) were restored with Componeer prefabricated veneers (Coltène, Altstätten, Switzerland) in combination with Synergy D6 nanohybrid resin composite (Coltène) and One Coat Bond (Coltène) adhesive system. In Group 2; 54 teeth (15 patients) were restored with Essentia (GC, Japan) micro-hybrid resin composite in combination with G-Premio Bond (GC) adhesive system.
Periodontal treatments, fillings, and bleaching treatments were performed, if necessary, before any veneer treatment. For the pre-treatment records; 3 photographs (smile, anterior occlusion, and upper anterior teeth alone) were taken from each patient. Both groups used the "Button Try" technique for color selection. Componeer sizing guide was used for size selection in Group 1. Then teeth were cleaned with non-fluoride pumice (Cleanic; Kerr Dental, ABD) using a polishing brush. Isolation of the teeth and retraction of the lips were achieved with a rubber dam (OptraDam, Ivoclar Vivadent, Liechtenstein). Prefabricated veneers were prepared for the cementation process in Group 1. Then the labial surfaces were etched using 36% phosphoric acid for 30 s. The etched surfaces were rinsed for 30 s and dried. One Coat Bond (Coltene) adhesive system was applied on the labial surfaces of the teeth in accordance with user instructions in both groups. In Group 1; Synergy D6 nano hybrid resin composite was placed on the inner surfaces of the prefabricated veneers before being applied on appropriate teeth. Then the restorations were light-cured for 40 s from each surface (D-Light Pro, GC) and polished with a polishing paste (Prisma Gloss Extra Fine, Dentsply, NY, ABD) and a felt wheel.
In Group 2; Essentia (GC) micro-hybrid resin composite with dentin color was placed on the labial surfaces of the teeth and light-cured (D-Light Pro, GC). After that layer, Essentia enamel shades were placed over the labial surface of the tooth and light-cured for 20 s from each surface. The diamond bur contouring was performed and polishing discs (Super-Snap Rainbow Technique Kit, SHOFU) were used. For polishing purposes, a polishing paste (Prisma Gloss Extra Fine, Dentsply, NY, ABD) and a felt Wheel were used.
In group 1; gingival borders were adapted with contouring and polishing discs (Super-Snap Rainbow Technique Kit, SHOFU). Then proximal surfaces were polished using proximal sandpaper strips. Occlusion was checked for premature contacts. Two calibrated observers who were blinded to the objective of this study performed the evaluations. Color match, marginal adaptation, marginal discoloration, anatomic form, retention, secondary caries, and gloss retention were the properties evaluated for the restorations at baseline, 1-2-6-year using Modified Ryge Criteria (USPHS Criteria). Statistical analysis was performed with McNemar and Chi-square tests (p<0.05).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Individual Randomized Assignment
| Arm | Type | Receives |
|---|---|---|
| Componeer Prefabricated Veneers | Active comparator | Procedure: Componeer prefabricated veneersComponeer veneers (device 1) were randomly applied to patients. The teeth were evaluated in terms of color and size matching in order to select the correct veneers. Componeer sizing guide was used for size selection. Prefabricated veneers were adapted to the teeth' surfaces. Then, the inner surfaces of the prefabricated veneers were roughened to obtain better mechanical retention. Then the labial surfaces of the teeth were etched using 36% phosphoric acid. The etched surfaces were rinsed and dried. An adhesive system was applied to the teeth. Prefabricated veneers' inner surfaces were cleaned with alcohol, and One Coat dental adhesive was applied. Synergy D6 nanohybrid resin composite was placed on the inner surfaces of the veneers and transferred to the teeth. The restorations were light-cured for 40 s Gingival borders were adapted with contouring and polishing discs (intervention 1). |
| Essentia resin composite venners | Active comparator | Procedure: Essentia resin composite veneersDirect resin composite restorations were randomly applied to patients. Essentia resin composite (device 2) shade guide was used for color selection. After the preparation, the labial surfaces of the teeth were etched using 36% phosphoric acid. The etched surfaces were then rinsed and dried. An adhesive system G-Premio Bond was applied to the teeth. Then Essentia micro-hybrid resin composite with dentin shade was placed on labial surfaces of teeth and was light-cured. Then enamel shade was placed on the tooth. After that, the resin composite veneer was light-cured for 20 s from each surface. Proximal surfaces were polished using proximal sandpaper strips (intervention 2). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Being healthy without any chronic disease
- Having diastema in the anterior teeth without any caries
- Not having an occlusal anomaly such as bruxism or anterior crossbite
- Having a good oral hygiene
- Agreeing to come to the recall sessions regularly for 6 years
Key exclusion criteria (4 listed)
- Having uncontrolled parafunction such as bruxism or anterior deep bite
- Having insufficient oral hygiene
- Being pregnant
- Having a systemic disease
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 |
|---|---|---|
| Componeer prefabricated veneersIndividual Randomized Clinical Trial | Procedure or surgery | Componeer Prefabricated Veneers |
| Essentia resin composite veneersIndividual Randomized Clinical Trial | Procedure or surgery | Essentia resin composite venners |
Primary outcome
Marginal discoloration
Time frame: 6 years
Marginal discoloration of prefabricated and resin composite veneers Evaluating differently veneer options on anterior teeth with United State Public Health Service criteria regarding marginal discoloration by 2 independent evaluators Marginal discolouration was evaluated by 2 independent clinicians. Visual inspection with a mirror at 18 inches was performed. A score means the higher score of clinical acceptability while C score means that the restoration has failed and needs to be replaced. Alpha: No discoloration anywhere along the margin between the restoration and the adjacent tooth. Bravo: Slight discoloration along the margin between the restoration and the adjacent tooth. Charlie: The discoloration penetrated along the margin of the restorative material in a pulpal direction.
Marginal adaptation
Time frame: 6 years
Marginal adaptation of prefabricated and resin composite veneers Evaluating differently veneer options on anterior teeth with United State Public Health Service criteria regarding marginal adaptation by 2 independent evaluators Marginal discolouration was evaluated by 2 independent clinicians. Visual inspection with a mirror at 18 inches was performed . A score means the higher score of clinical acceptability while C score means that the restoration has failed and needs to be replaced. Alpha: No discoloration anywhere along the margin between the restoration and the adjacent tooth. Bravo: Slight discoloration along the margin between the restoration and the adjacent tooth. Charlie: The discoloration penetrated along the margin of the restorative material in a pulpal direction.
Retention rate
Time frame: 6 years
Retention rates of prefabricated and resin composite veneers Evaluating differently veneer options on anterior teeth with United State Public Health Service criteria regarding retention rates by 2 independent evaluators Marginal discolouration was evaluated by 2 independent clinicians. Visual inspection with a mirror at 18 inches was performed . A score means the higher score of clinical acceptability while C score means that the restoration has failed and needs to be replaced. Alpha: No discoloration anywhere along the margin between the restoration and the adjacent tooth. Bravo: Slight discoloration along the margin between the restoration and the adjacent tooth. Charlie: The discoloration penetrated along the margin of the restorative material in a pulpal direction.
Anatomic form
Time frame: 6 years
Anatomic form of prefabricated and resin composite veneers Evaluating differently veneer options on anterior teeth with United State Public Health Service criteria regarding anatomic form by 2 independent evaluators Marginal discolouration was evaluated by 2 independent clinicians. Visual inspection with a mirror at 18 inches was performed. A score means the higher score of clinical acceptability while C score means that the restoration has failed and needs to be replaced. Alpha: No discoloration anywhere along the margin between the restoration and the adjacent tooth. Bravo: Slight discoloration along the margin between the restoration and the adjacent tooth. Charlie: The discoloration penetrated along the margin of the restorative material in a pulpal direction.
Color match
Time frame: 6 years
Color changes of prefabricated and resin composite veneers Health Service criteria regarding color changes by 2 independent evaluators Marginal discolouration was evaluated by 2 independent clinicians. Visual inspection with a mirror at 18 inches was performed . A score means the higher score of clinical acceptability while C score means that the restoration has failed and needs to be replaced. Alpha: No discoloration anywhere along the margin between the restoration and the adjacent tooth. Bravo: Slight discoloration along the margin between the restoration and the adjacent tooth. Charlie: The discoloration penetrated along the margin of the restorative material in a pulpal direction
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 21 Aug 2023.
- 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.
Sebnem L Turkun, DDS,PhD study director
Ege University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Componeer prefabricated veneers and Essentia resin composite veneers in people with Dental Diseases and Tooth Discoloration, run by Ege University at 1 site in Turkey (Türkiye).
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 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: finished, as of the sponsor's last update on 21 Aug 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 Turkey (Türkiye). 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?
Marginal discoloration (time frame: 6 years). The study lists 5 primary outcomes in all. 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 21 Aug 2023.