Cavities of TeethNCT03716349
Esthetics of Dental Composite and Adhesive System
A study testing Pulp vitality testing, Photos and local and/or topical anesthetic in people with Cavities of Teeth, run by Erica Teixeira at 1 site in United States.
Trial summary
To compare a newly developed filling composite to a current filling composite system. Two restorations will be placed in each subject, one using system A and one using system B. The first system listed in the randomization pair will be placed on first tooth (#4-#13), and the second system on 2nd tooth (#4-#13). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cavities of Teeth
- What is being tested?
- Pulp vitality testing, Photos and local and/or topical anesthetic
- Type of treatment
- Pill or oral medicine, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2019to 20 Nov 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Sensible tooth -responds to cold or electric pulp testing (done at screening)
- Patient 18years of age or old
- Current radiograph available (done at screening as needed)
- A pair of the same type of restorations needed in the anterior esthetic/facial region (tooth #4-#13).
Who cannot join
- Fewer than 20 teeth
- Advanced untreated periodontal disease or recent periodontal surgery
- Rampant uncontrolled caries activity
- Bruxism or clenching and visible wear facets on the occlusal surface
- Undergoing or in need of TMJ therapy
- Known allergy to methacrylate-based materials or product ingredients
Show all 18Show fewer
- History of poor dental visit attendance
- Not available for recall for at least 3 years
- Fractured or visibly cracked tooth
- Poor oral hygiene
- Sensitive tooth or currently using desensitizing treatments, pastes or medicaments
- Pregnant
- Abutment teeth for prostheses
- Teeth considered for restoration are non-vital, have had root canal therapy or been pulp capped
- Teeth or supporting structures with any symptomatic pathology or extensive caries lesion
- Individual supervised by PI or supervised by member of research team
- Individual subordinate to the PI or subordinate to any member of the research team
- Student or trainee under the direction of the PI or under the direction of a member of the research team
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Esthetic Outcomes of a Newly Developed Dental Composite and Adhesive System: a Randomized Clinical Trial
To compare a newly developed filling composite to a current filling composite system. Two restorations will be placed in each subject, one using system A and one using system B. The first system listed in the randomization pair will be placed on first tooth (#4-#13), and the second system on 2nd tooth (#4-#13). The same three researchers will be responsible for placement of all the restorations.
Read the detailed description
The aim of this (12-month; 36-month; 60-month) randomized controlled clinical trial is to evaluate and compare the esthetic outcomes and patient satisfaction of a simplified newly developed dental composite system (system A)for the esthetic region to a nanohybrid composite system (Filtek Supreme Ultra-system B) placed in class III, IV and V lesions. Even though dental composite systems have been used extensively for the anterior region, clinicians face challenges with shade selection and longevity of the material over the years. This new system has been developed to improve the esthetic outcomes and patient satisfaction by enhancing the blending capability of the material.
Dental composite systems have been used for 50 years as state of art materials to restore the anterior region. Significant development has occurred regarding the composition and structure of dental composites, improving the longevity of these restorations; however, clinicians are faced with the challenge of selecting the most adequate shade and restorative technique to reproduce missing tooth structure.
Depending on the size of the cavity preparation, a single layer of material or multiple layers might be needed to reproduce dentin and enamel. Different dental composite systems offer multiple body, dentin, and enamel shades. Therefore, clinicians are faced with the challenge of recreating nature using this material. Different devices, such as spectrophotometers have been introduced on the market for shade selection. However, one of the most important aspects when placing anterior composites is the esthetic outcome based on the patient's assessment. Therefore, this study will evaluate the esthetic outcomes of a simplified and a conventional dental composite system based on the provider's and patient's assessment.
- Conditions
- Cavities of Teeth
- Being tested
- Pulp vitality testing, Photos, local and/or topical anesthetic, rubber dam, tooth surface cleaned
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulp vitality testingDiagnostic test
each tooth will be tested to determine if the pulp of the tooth responds to cold
PhotosOther
Photos of teeth (Photos will be taken with a DSLR camera settings will be determined with optimal settings) and captured periodically throughout the study. Photographs will be made of the cavity preparation. Photographs will be made post-operatively
local and/or topical anestheticDrug
Local and/or topical anesthetic will be applied as necessary to the teeth or gingiva
rubber damDevice
The area will be isolated with rubber dam isolation
tooth surface cleanedOther
The tooth surface will be cleaned with flour of pumice on a prophy cup only, cavity preparation will be performed as usual for caries removal.
enamel marginsProcedure or surgery
Enamel margins will be beveled with a long flame diamond bur (8863.314.012 Komet) at 45 degrees to the external tooth surface to achieve the desired bevel length. Along with the use of the diamond bur, infinite invisible margins will be created by contouring and smoothing with a dark orange Sof-LexTM extra-thin contouring and polishing disc (3M).
Adhesive SystemsProcedure or surgery
Adhesive systems will be applied according to manufacturer's instructions and selective etching of the enamel will be performed. The dental composite will be incrementally placed using a two- layer or one-layer technique based on the cavity size and light-cured (detailed adhesive instruction sheet will be chairside for reference)
cavity preparationProcedure or surgery
The technique to be used will be determined by the size of the final cavity preparation. For small preparations a one-layer technique will be used. No backing material is necessary for the Tokuyama system, Filtek Supreme Ultra will be determined by manufacturer's wheel. A two-layer technique will be used for a large cavity preparation. Large cavity preparation is defined as being 4mm in length or more and/or at least 2mm in depth.
Shade selection using Easy Shade 5Other
A1 (shade determined by Easy Shade 5), ECM-001/Backing material, A1E/A2D (shade will be selected by shade wheel) A4 (shade determined by Easy shade5), ECM-001/Backing material, A3E/A6D (shade will be selected by shade wheel
Light CuringProcedure or surgery
A Valo Grand curing unit (Ultradent) with an exitant irradiance with no less than 500 and no greater than 1500 mW/cm2 as measured with MARC Light Collector will be used in standard mode to deliver the required radiant exposure J/cm2 for adhesive and dental composite increments.
Contoured and polishedProcedure or surgery
The restoration will be contoured and polished with - Long flame diamond bur (8863.314.012 Komet), Sof-Lex Medium (orange) Contouring and Polishing Discs (3M), Green Jiffy cup pre-polisher (Ultradent Products, Inc.), Blue and grey silicone points composite polisher gloss plus finisher (Kerr Hawe)
ConsentOther
The consent form will be signed, copy will be provided to the patient
Health QuestionnaireOther
The health questionnaire will be completed at initial visit and updated at each follow-up visit
xrayRadiation
When necessary a radiograph (xray) will be obtained
Release of medical information signedOther
The release of medical information form will be signed
Oral ExamOther
An Oral Exam will be completed
Teeth AssessmentOther
The teeth assessment by subject will be completed using the Visual Analog Scale (VAS) and Verbal Rating Scale (VRS) at the follow-up visits 1 month after restoration, 1 year, 2 years and 3 years post restoration.
Clinical AssessmentOther
A clinical assessment will be completed by the evaluators
Tokuyama Universal BondDevice
Tokuyama Universal Bond (TUB) single component self-etching 1-step adhesive system with Tokyuama supra-nanofilled dental composite (ECM) (Tokuyama Dental Corp., Japan)
ScotchBondDevice
Scotch Bond Universal one-step adhesive system with Filtek Supreme Ultra™, nanofilled dental composite (3M)
| Study group | Role | What they receive |
|---|---|---|
| System A | Experimental | Tokuyama Universal Bond (TUB) single component self-etching 1-step adhesive system w/Tokyuama supra-nanofilled dental composite (ECM) (Tokuyama Dental Corp., Japan), informed consent signed, release of medical information signed, oral exam, health Questionnaire completed and/or updated, xray obtained if needed, pulp vitality testing, Tooth shade determination, photos of teeth, local and/or topical anesthetic applied as necessary, rubber dam isolation, tooth surface cleaned, cavity preparation performed as usual for caries removal, Enamel margins beveled, infinite invisible margins created, adhesive systems applied, dental composite placed, shade selection using Easy Shade 5. Light curing, restoration will be contoured and polished. teeth assessment, clinical assessment Receives: Diagnostic Test: Pulp vitality testing; Other: Photos; Drug: local and/or topical anesthetic; Device: rubber dam; Other: tooth surface cleaned; Procedure: enamel margins; Procedure: Adhesive Systems; Procedure: cavity preparation; Other: Shade selection using Easy Shade 5; Procedure: Light Curing; Procedure: Contoured and polished; Other: Consent; Other: Health Questionnaire; Radiation: xray; Other: Release of medical information signed; Other: Oral Exam; Other: Teeth Assessment; Other: Clinical Assessment; Device: Tokuyama Universal Bond |
| System B | Active comparator | ScotchBond Universal one-step adhesive system with Filtek Supreme Ultra™, nanofilled dental composite (3M) will randomly be applied to the other tooth informed consent signed, release of medical information signed, oral exam, health Questionnaire completed and/or updated, xray obtained if needed, pulp vitality testing, Tooth shade determination, photos of teeth, local and/or topical anesthetic applied as necessary, rubber dam isolation, tooth surface cleaned, cavity preparation performed as usual for caries removal, Enamel margins beveled, infinite invisible margins created, adhesive systems applied, dental composite placed, shade selection using Easy Shade 5. Light curing, restoration will be contoured and polished. teeth assessment and clinical assessment at periodic timepoints. Receives: Diagnostic Test: Pulp vitality testing; Other: Photos; Drug: local and/or topical anesthetic; Device: rubber dam; Other: tooth surface cleaned; Procedure: enamel margins; Procedure: Adhesive Systems; Procedure: cavity preparation; Other: Shade selection using Easy Shade 5; Procedure: Light Curing; Procedure: Contoured and polished; Other: Consent; Other: Health Questionnaire; Radiation: xray; Other: Release of medical information signed; Other: Oral Exam; Other: Teeth Assessment; Other: Clinical Assessment; Device: ScotchBond |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Satisfaction of the Restoration's Appearance (Esthetics) Using the Visual Analog Scale
For each system, the Visual Analog Scale of 0-100 with 0 being a poor result and 100 being an excellent result will be used for the subject to voluntarily assess their satisfaction with each restoration's appearance.
Measured: 5 years
Secondary outcomes (1)
Patient Satisfaction of the Restoration Appearance (Esthetics) Using the Verbal Rating Scale
For each system, the Verbal Rating Scale with 1 being a "Not at all Satisfied", 2 being "Somewhat Satisfied", 3 being "Satisfied" and 4 being "Very Satisfied" will be used for the subject to voluntarily assess their satisfaction with each restoration's appearance.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2018
- Study start1 Jan 2019
- Primary completion20 Nov 2025
- Study completion20 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cavities of TeethStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Simple randomization will be used for assignment of the treatment groups. Randomization: Two restorations will be placed in each subject, one using system A and one using system B.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erica Teixeira
- Sponsor type
- University, hospital or other
- Collaborators
- Tokuyama Dental Corporation
- Responsible party
- Sponsor-investigator, Erica Teixeira, University of Iowa
- Investigators
- Erica Teixeira, DDS, MS, PhD, Principal investigator, University of Iowa College of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03716349
- Sponsor's protocol ID
- 201809844
- Status last verified
- Feb 2026
- First submitted
- 1 Oct 2018
- Last updated
- 1 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Esthetic Outcomes of a Newly Developed Dental Composite and Adhesive System: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03716349
- Acronym / sponsor ID
- 201809844
- Conditions
- Cavities of Teeth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Erica TeixeiraUniversity, hospital or other
- Collaborators
- Tokuyama Dental Corporation
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 20 Nov 2025 (actual)
- Study completion
- 20 Nov 2025 (actual)
- First posted
- 23 Oct 2018 (actual)
- Results
- Posted 1 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare a newly developed filling composite to a current filling composite system. Two restorations will be placed in each subject, one using system A and one using system B. The first system listed in the randomization pair will be placed on first tooth (#4-#13), and the second system on 2nd tooth (#4-#13). The same three researchers will be responsible for placement of all the restorations.
Detailed description
The aim of this (12-month; 36-month; 60-month) randomized controlled clinical trial is to evaluate and compare the esthetic outcomes and patient satisfaction of a simplified newly developed dental composite system (system A)for the esthetic region to a nanohybrid composite system (Filtek Supreme Ultra-system B) placed in class III, IV and V lesions. Even though dental composite systems have been used extensively for the anterior region, clinicians face challenges with shade selection and longevity of the material over the years. This new system has been developed to improve the esthetic outcomes and patient satisfaction by enhancing the blending capability of the material.
Dental composite systems have been used for 50 years as state of art materials to restore the anterior region. Significant development has occurred regarding the composition and structure of dental composites, improving the longevity of these restorations; however, clinicians are faced with the challenge of selecting the most adequate shade and restorative technique to reproduce missing tooth structure.
Depending on the size of the cavity preparation, a single layer of material or multiple layers might be needed to reproduce dentin and enamel. Different dental composite systems offer multiple body, dentin, and enamel shades. Therefore, clinicians are faced with the challenge of recreating nature using this material. Different devices, such as spectrophotometers have been introduced on the market for shade selection. However, one of the most important aspects when placing anterior composites is the esthetic outcome based on the patient's assessment. Therefore, this study will evaluate the esthetic outcomes of a simplified and a conventional dental composite system based on the provider's and patient's assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Simple randomization will be used for assignment of the treatment groups. Randomization: Two restorations will be placed in each subject, one using system A and one using system B.
| Arm | Type | Receives |
|---|---|---|
| System A | Experimental | Diagnostic Test: Pulp vitality testing, Other: Photos, Drug: local and/or topical anesthetic, Device: rubber dam, Other: tooth surface cleaned, Procedure: enamel margins, Procedure: Adhesive Systems, Procedure: cavity preparation, Other: Shade selection using Easy Shade 5, Procedure: Light Curing, Procedure: Contoured and polished, Other: Consent, Other: Health Questionnaire, Radiation: xray, Other: Release of medical information signed, Other: Oral Exam, Other: Teeth Assessment, Other: Clinical Assessment, Device: Tokuyama Universal BondTokuyama Universal Bond (TUB) single component self-etching 1-step adhesive system w/Tokyuama supra-nanofilled dental composite (ECM) (Tokuyama Dental Corp., Japan), informed consent signed, release of medical information signed, oral exam, health Questionnaire completed and/or updated, xray obtained if needed, pulp vitality testing, Tooth shade determination, photos of teeth, local and/or topical anesthetic applied as necessary, rubber dam isolation, tooth surface cleaned, cavity preparation performed as usual for caries removal, Enamel margins beveled, infinite invisible margins created, adhesive systems applied, dental composite placed, shade selection using Easy Shade 5. Light curing, restoration will be contoured and polished. teeth assessment, clinical assessment |
| System B | Active comparator | Diagnostic Test: Pulp vitality testing, Other: Photos, Drug: local and/or topical anesthetic, Device: rubber dam, Other: tooth surface cleaned, Procedure: enamel margins, Procedure: Adhesive Systems, Procedure: cavity preparation, Other: Shade selection using Easy Shade 5, Procedure: Light Curing, Procedure: Contoured and polished, Other: Consent, Other: Health Questionnaire, Radiation: xray, Other: Release of medical information signed, Other: Oral Exam, Other: Teeth Assessment, Other: Clinical Assessment, Device: ScotchBondScotchBond Universal one-step adhesive system with Filtek Supreme Ultra™, nanofilled dental composite (3M) will randomly be applied to the other tooth informed consent signed, release of medical information signed, oral exam, health Questionnaire completed and/or updated, xray obtained if needed, pulp vitality testing, Tooth shade determination, photos of teeth, local and/or topical anesthetic applied as necessary, rubber dam isolation, tooth surface cleaned, cavity preparation performed as usual for caries removal, Enamel margins beveled, infinite invisible margins created, adhesive systems applied, dental composite placed, shade selection using Easy Shade 5. Light curing, restoration will be contoured and polished. teeth assessment and clinical assessment at periodic timepoints. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Sensible tooth -responds to cold or electric pulp testing (done at screening)
- Patient 18years of age or old
- Current radiograph available (done at screening as needed)
- A pair of the same type of restorations needed in the anterior esthetic/facial region (tooth #4-#13).
Key exclusion criteria (18 listed)
- Fewer than 20 teeth
- Advanced untreated periodontal disease or recent periodontal surgery
- Rampant uncontrolled caries activity
- Bruxism or clenching and visible wear facets on the occlusal surface
- Undergoing or in need of TMJ therapy
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 |
|---|---|---|
| Pulp vitality testingeach tooth will be tested to determine if the pulp of the tooth responds to cold | Diagnostic test | System A, System B |
| PhotosPhotos of teeth (Photos will be taken with a DSLR camera settings will be determined with optimal settings) and captured periodically throughout the study. Photographs will be made of the cavity preparation. Photographs will be made post-operatively | Other | System A, System B |
| local and/or topical anestheticLocal and/or topical anesthetic will be applied as necessary to the teeth or gingiva | Drug | System A, System B |
| rubber damThe area will be isolated with rubber dam isolation | Device | System A, System B |
| tooth surface cleanedThe tooth surface will be cleaned with flour of pumice on a prophy cup only, cavity preparation will be performed as usual for caries removal. | Other | System A, System B |
| enamel marginsEnamel margins will be beveled with a long flame diamond bur (8863.314.012 Komet) at 45 degrees to the external tooth surface to achieve the desired bevel length. Along with the use of the diamond bur, infinite invisible margins will be created by contouring and smoothing with a dark orange Sof-LexTM extra-thin contouring and polishing disc (3M). | Procedure or surgery | System A, System B |
| Adhesive SystemsAdhesive systems will be applied according to manufacturer's instructions and selective etching of the enamel will be performed. The dental composite will be incrementally placed using a two- layer or one-layer technique based on the cavity size and light-cured (detailed adhesive instruction sheet will be chairside for reference) | Procedure or surgery | System A, System B |
| cavity preparationThe technique to be used will be determined by the size of the final cavity preparation. For small preparations a one-layer technique will be used. No backing material is necessary for the Tokuyama system, Filtek Supreme Ultra will be determined by manufacturer's wheel. A two-layer technique will be used for a large cavity preparation. Large cavity preparation is defined as being 4mm in length or more and/or at least 2mm in depth. | Procedure or surgery | System A, System B |
| Shade selection using Easy Shade 5A1 (shade determined by Easy Shade 5), ECM-001/Backing material, A1E/A2D (shade will be selected by shade wheel) A4 (shade determined by Easy shade5), ECM-001/Backing material, A3E/A6D (shade will be selected by shade wheel | Other | System A, System B |
| Light CuringA Valo Grand curing unit (Ultradent) with an exitant irradiance with no less than 500 and no greater than 1500 mW/cm2 as measured with MARC Light Collector will be used in standard mode to deliver the required radiant exposure J/cm2 for adhesive and dental composite increments. | Procedure or surgery | System A, System B |
| Contoured and polishedThe restoration will be contoured and polished with - Long flame diamond bur (8863.314.012 Komet), Sof-Lex Medium (orange) Contouring and Polishing Discs (3M), Green Jiffy cup pre-polisher (Ultradent Products, Inc.), Blue and grey silicone points composite polisher gloss plus finisher (Kerr Hawe) | Procedure or surgery | System A, System B |
| ConsentThe consent form will be signed, copy will be provided to the patient | Other | System A, System B |
| Health QuestionnaireThe health questionnaire will be completed at initial visit and updated at each follow-up visit | Other | System A, System B |
| xrayWhen necessary a radiograph (xray) will be obtained | Radiation | System A, System B |
| Release of medical information signedThe release of medical information form will be signed | Other | System A, System B |
| Oral ExamAn Oral Exam will be completed | Other | System A, System B |
| Teeth AssessmentThe teeth assessment by subject will be completed using the Visual Analog Scale (VAS) and Verbal Rating Scale (VRS) at the follow-up visits 1 month after restoration, 1 year, 2 years and 3 years post restoration. | Other | System A, System B |
| Clinical AssessmentA clinical assessment will be completed by the evaluators | Other | System A, System B |
| Tokuyama Universal BondTokuyama Universal Bond (TUB) single component self-etching 1-step adhesive system with Tokyuama supra-nanofilled dental composite (ECM) (Tokuyama Dental Corp., Japan) | Device | System A |
| ScotchBondScotch Bond Universal one-step adhesive system with Filtek Supreme Ultra™, nanofilled dental composite (3M) | Device | System B |
Primary outcome
Patient Satisfaction of the Restoration's Appearance (Esthetics) Using the Visual Analog Scale
Time frame: 5 years
For each system, the Visual Analog Scale of 0-100 with 0 being a poor result and 100 being an excellent result will be used for the subject to voluntarily assess their satisfaction with each restoration's appearance.
1 secondary outcome
Patient Satisfaction of the Restoration Appearance (Esthetics) Using the Verbal Rating Scale
Time frame: 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Erica Teixeira, DDS, MS, PhD principal investigator
University of Iowa College of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulp vitality testing, Photos and local and/or topical anesthetic in people with Cavities of Teeth, run by Erica Teixeira at 1 site in United States.
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 4 inclusion and 18 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 1 May 2026. 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 United States. 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?
Yes. Results are posted in the registry (first posted 1 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Patient Satisfaction of the Restoration's Appearance (Esthetics) Using the Visual Analog Scale (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.