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This is a prospective, controlled, within-subject, randomized, single-center study comparing Scotchbond Universal Plus (SBU+) and Scotchbond Universal (SBU) adhesives when used with Filtek restorative. The study will enroll Subjects scheduled to undergo Class-V non-carious cervical lesion (NCCL) restorations.
This is a prospective, controlled, within-subject, randomized, single-center study that will enroll Subjects scheduled to undergo Class-V NCCL restorations on 2 or 4 teeth treated in pairs according to lesion depth. Enough subjects will be enrolled from a single site located in New Orleans, Louisiana, USA to perform a minimum of 110 restorations (estimated 38 subjects). Each study tooth will be restored using only one type of adhesive, either SBU+ or SBU, and Filtek restorative following manufacturer's directions using the "Total Etch/Etch and Rinse Procedure". Any teeth needing treatment that are not included in the study will be treated by the dentist using the standard of care.
Subjects will be seen during screening (≤21 days before the restoration procedure), on the day of the restoration procedure, 7 days (± 3 days) after restoration (remote visit for subject self-assessment of baseline hypersensitivity), and follow-up visits at 6 months (± 14 days), 1 year (± 30 days), and 2 years (± 45 days) after restorations. Study teeth will be assessed for selected endpoints based partly on FDI (Fédération Dentaire Internationale) World Dental Federation criteria. Subjects may participate in additional unscheduled visits as required during the study if evaluation of any study tooth is required outside of the scheduled study visits. The entire duration of the study is expected to last approximately 3 years, with individual Subject participation expected to last up to 2 years (± 45 days).
To help minimize or avoid bias in the study, randomization of study teeth will occur after teeth preparation but before the initial application of any adhesive. Assessments will be performed by 2 dental examiners that are independent of the dentist that placed the restorations and are blinded to the treatment arms. All examiners will be trained and calibrated for the scoring criteria before any Subject assessment occurs, and examiners will be retrained and recalibrated if any new evaluator is added to the list of assessors. After the second examiner has completed their assessments, the examiners will compare their evaluations and a consensus will be reached for each of the scoring criteria at each visit before the Subject leaves the visit. The consensus assessments will be entered into the Case Report Form (CRF).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SBU+ Treatment Group | Experimental | In a split-mouth design, either 1 tooth (for Subjects with 2 eligible teeth) or 2 teeth (for Subjects with 4 eligible teeth) with Class-V NCCLs underwent restoration(s) using Scotchbond Universal Plus (SBU+) Adhesive . |
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| SBU Control Group | Active Comparator | In a split-mouth design, either 1 tooth (for Subjects with 2 eligible teeth) or 2 teeth (for Subjects with 4 eligible teeth) with Class-V NCCLs underwent restoration(s) using the predicate device, Scotchbond Universal (SBU) Adhesive. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Scotchbond Universal Plus Adhesive | Device | Eligible teeth with Class-V NCCLs randomized to the SBU+ treatment group underwent restoration(s) using Scotchbond Universal Plus (SBU+) Adhesive using total-etch mode and Filtek Universal Restorative material. |
| Measure | Description | Time Frame |
|---|---|---|
| Retention of Restorative Material | The percentage of restorations with partial or complete loss of the restorative materials. | 24 months post-restoration |
| Marginal Adaptation | Marginal adaptation of restorations graded on a scale of 1-5 with a score of 1 being Excellent/very good and a score of 5 being Poor. Grading scale is based on modified FDI (Fédération Dentaire Internationale) World Dental Federation criteria. Scoring categories for marginal adaptation:
| 24 months post-restoration |
| Measure | Description | Time Frame |
|---|---|---|
| Retention of Restorative Material | The percentage of restorations with partial or complete loss of the restoration material. | 6 months post-restoration |
| Marginal Adaptation | Marginal adaptation of restorations graded on a scale of 1-5 with a score of 1 being Excellent/very good and a score of 5 being Poor. Grading scale is based on modified FDI World Dental Federation criteria. Scoring categories for marginal adaptation:
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Inclusion Criteria:
Subjects may be included that meet the following criteria:
Subject is at least 18 years of age at the time of consent
Subject is able to provide their own informed consent
Subject has a minimum of two teeth that:
Subject has an Approximal Plaque Index score ≤ 40% as assessed via explorer and without the use of plaque-disclosing agents
Subject is able and willing to return for all scheduled study visits
Subject meets the Level-I or Level-II classification criteria of the American Society of Anesthesiologists (ASA) Physical Status Classification System For Dental Patient Care
Exclusion Criteria:
Subjects may not be included that meet any of the following criteria:
Subject has any of the following:
Subject is unable, for any reason, to tolerate the procedure time required to place the restorations
Subject has unacceptable oral hygiene (eg, chronic moderate to heavy plaque accumulation along the gumline)
Subject has known sensitivity to the study product components (ie, acrylate)
Subject is planned to be enrolled in another investigational trial that requires additional interventions at any time during the study
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| Name | Affiliation | Role |
|---|---|---|
| Alika Yu, DDS | Louisiana State University HSC Health, School of Dentistry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Louisiana State University HSC-Health, School of Dentistry | New Orleans | Louisiana | 70119 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20628774 | Background | Hickel R, Peschke A, Tyas M, Mjor I, Bayne S, Peters M, Hiller KA, Randall R, Vanherle G, Heintze SD. FDI World Dental Federation: clinical criteria for the evaluation of direct and indirect restorations-update and clinical examples. Clin Oral Investig. 2010 Aug;14(4):349-66. doi: 10.1007/s00784-010-0432-8. Epub 2010 Jul 14. | |
| 23327229 |
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Subjects were required to meet all inclusion and none of the exclusion criteria to be eligible. A total of 38 subjects were screened and of those, 32 subjects were treated. Two or four Class V restorations were placed per patient, randomized in a 1:1 ratio with half of the teeth (i.e., 1 tooth for Subjects with 2 eligible teeth, or 2 teeth for Subjects with 4 eligible teeth) randomized to the SBU+ Adhesive Treatment group and the other half to the SBU Adhesive Control group.
The patient population was selected from current patients under clinical treatment at Louisiana State University (LSU), School of Dentistry. Patients were between the ages of 18 and 70 years old at time of consent, of either sex, and of any ethnic background. Eligible patients needed to have at least two teeth with Class V non-carious cervical lesions (NCCL) at least 1.5 mm deep, in vital teeth that had not undergone root canal treatment.
| ID | Title | Description |
|---|---|---|
| FG000 | SBU+ Treatment Group | Either 1 tooth (for Subjects with 2 eligible teeth) or 2 teeth (for Subjects with 4 eligible teeth) with Class-V NCCLs will undergo restoration(s) using Scotchbond Universal Plus (SBU+) Adhesive . Scotchbond Universal Plus Adhesive: Eligible teeth with Class-V NCCLs randomized to the SBU+ treatment group will undergo restoration(s) using Scotchbond Universal Plus (SBU+) Adhesive using total-etch mode and Filtek Universal Restorative material. |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 9, 2022 |
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Each subject had either two restorations (two teeth) or four restorations (four teeth) performed at the beginning of the study, with each tooth restoration using only one type of adhesive. Study teeth were paired according to lesion depth and randomized to treatment in a 1:1 ratio with at least half of the teeth (ie, 1 tooth for Subjects with 2 eligible teeth or 2 teeth for Subjects with 4 eligible teeth) randomized to undergo restoration(s) using Scotchbond Universal Plus Adhesive (SBU+ Treatment group) and the other half of the teeth undergoing restoration(s) using Scotchbond Universal Adhesive (SBU Control group).
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All assessments were performed by two dental examiners that were independent of the dentist that placed the restorations and were blinded to the treatment arms.
| Scotchbond Universal Adhesive | Device | Eligible teeth with Class-V NCCLs randomized to the SBU Control group underwent restoration(s) using Scotchbond Universal Plus (SBU) Adhesive using total-etch mode and Filtek Universal Restorative material. |
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| 6 months post restoration |
| Fracture of Restorative Material | Fractures on study teeth graded on a 0-4 grading scale with a score of 1 being Excellent/very good and a score of 4 being Unsatisfactory. Grading scale is based on modified FDI World Dental Federation criteria. Scoring categories for the fracture of restorative material are defined as follows:
| 6 months post-restoration |
| Secondary Caries | Secondary caries in study teeth scored on scale 1-5.
| 6 months post-restoration |
| Retention of Restorative Material | The percentage of restorations with partial or complete loss of the restoration material. | 12 months post-restoration |
| Marginal Adaptation | Marginal adaptation of restorations graded on a scale of 1-5 with a score of 1 being Excellent/very good and a score of 5 being Poor. Grading scale is based on modified FDI World Dental Federation criteria. Scoring categories for marginal adaptation:
| 12 months post-restoration |
| Fracture of Restorative Material | Fractures on study teeth graded on a 1-4 grading scale with a score of 1 being Excellent/very good and a score of 4 being Unsatisfactory. Grading scale is based on modified FDI World Dental Federation criteria. Scoring categories for the fracture of restorative material are defined as follows:
| 12 months post-restoration |
| Secondary Caries | Secondary caries in study teeth graded on a 1-5 grading scale with a score of 1 being Excellent/very good and a score of 5 being Poor. Grading scale is based on modified FDI World Dental Federation criteria. Scoring categories for secondary caries are defined as follows.
| 12 months post-restoration |
| Fracture of Restorative Material | Fractures on study teeth graded on a 1-4 grading scale with a score of 1 being Excellent/very good and a score of 4 being Unsatisfactory. Grading scale is based on modified FDI World Dental Federation criteria. Scoring categories for the fracture of restorative material are defined as follows:
| 24 months post-restoration |
| Secondary Caries | Secondary caries in study teeth graded on a 1-5 grading scale with a score of 1 being Excellent/very good and a score of 5 being Poor. Grading scale is based on modified FDI World Dental Federation criteria. Scoring categories for secondary caries are defined as follows.
| 24 months post-restoration |
| Burgess JO, Sadid-Zadeh R, Cakir D, Ramp LC. Clinical evaluation of self-etch and total-etch adhesive systems in noncarious cervical lesions: a two-year report. Oper Dent. 2013 Sep-Oct;38(5):477-87. doi: 10.2341/12-355-CR. Epub 2013 Jan 17. |
| 26231300 | Background | Lawson NC, Robles A, Fu CC, Lin CP, Sawlani K, Burgess JO. Two-year clinical trial of a universal adhesive in total-etch and self-etch mode in non-carious cervical lesions. J Dent. 2015 Oct;43(10):1229-34. doi: 10.1016/j.jdent.2015.07.009. Epub 2015 Jul 29. |
| FG001 | SBU Control Group | Either 1 tooth (for Subjects with 2 eligible teeth) or 2 teeth (for Subjects with 4 eligible teeth) with Class-V NCCLs will undergo restoration(s) using the predicate device, Scotchbond Universal (SBU) Adhesive. Scotchbond Universal Adhesive: Eligible teeth with Class-V NCCLs randomized to the SBU Control group will undergo restoration(s) using Scotchbond Universal Plus (SBU) Adhesive using total-etch mode and Filtek Universal Restorative material. |
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| COMPLETED |
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| NOT COMPLETED |
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One subject was withdrawn by the IRB and included in the safety analysis set (32 treated subjects with 110 restorations) but was excluded from all efficacy analyses (31 subjects with 106 restorations). Eligible subjects had either 2 or 4 teeth treated in a 1:1 ratio with half the teeth randomized to the treatment group and the other half in the control group.
| ID | Title | Description |
|---|---|---|
| BG000 | SBU+ Treatment Group | Either 1 tooth (for Subjects with 2 eligible teeth) or 2 teeth (for Subjects with 4 eligible teeth) with Class-V NCCLs will undergo restoration(s) using Scotchbond Universal Plus (SBU+) Adhesive . Scotchbond Universal Plus Adhesive: Eligible teeth with Class-V NCCLs randomized to the SBU+ treatment group will undergo restoration(s) using Scotchbond Universal Plus (SBU+) Adhesive using total-etch mode and Filtek Universal Restorative material. |
| BG001 | SBU Control Group | Either 1 tooth (for Subjects with 2 eligible teeth) or 2 teeth (for Subjects with 4 eligible teeth) with Class-V NCCLs will undergo restoration(s) using the predicate device, Scotchbond Universal (SBU) Adhesive. Scotchbond Universal Adhesive: Eligible teeth with Class-V NCCLs randomized to the SBU Control group will undergo restoration(s) using Scotchbond Universal Plus (SBU) Adhesive using total-etch mode and Filtek Universal Restorative material. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Restorations |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | One subject withdrawn by the IRB was not included in the full analysis set. | Mean | Standard Deviation | years | Participants |
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| Age, Customized | Measure Analysis Population Description: One subject withdrawn by the IRB was not included in the full analysis set. | Number | years | Participants |
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| Sex/Gender, Customized | Measure Analysis Population Description: One subject withdrawn by the IRB was not included in the full analysis set. | Number | participants | Participants |
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| Race/Ethnicity, Customized | Number | participants | Participants |
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| Region of Enrollment | One subject withdrawn by the IRB was not included in the full analysis set. | Number | participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||
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| Primary | Retention of Restorative Material | The percentage of restorations with partial or complete loss of the restorative materials. | This includes the full analysis set with data imputation when necessary. One (1) subject withdrawn by the IRB was not included in efficacy analyses. | Posted | Number | percentage of restorations | 24 months post-restoration | Restorations | Restorations |
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| Primary | Marginal Adaptation | Marginal adaptation of restorations graded on a scale of 1-5 with a score of 1 being Excellent/very good and a score of 5 being Poor. Grading scale is based on modified FDI (Fédération Dentaire Internationale) World Dental Federation criteria. Scoring categories for marginal adaptation:
| This includes the full analysis set with data imputation when necessary. One (1) subject withdrawn by the IRB was not included in efficacy analyses. | Posted | Number | percentage of restorations | 24 months post-restoration | Restorations | Restorations |
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| Secondary | Retention of Restorative Material | The percentage of restorations with partial or complete loss of the restoration material. | This includes the full analysis set with data imputation when necessary. One (1) subject withdrawn by the IRB was not included in efficacy analyses. | Posted | Number | percentage of restorations | 6 months post-restoration | Restorations | Restorations |
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| Secondary | Marginal Adaptation | Marginal adaptation of restorations graded on a scale of 1-5 with a score of 1 being Excellent/very good and a score of 5 being Poor. Grading scale is based on modified FDI World Dental Federation criteria. Scoring categories for marginal adaptation:
| Four (4) of 31 subjects missed the 6-month follow-up visit. One (1) subject was withdrawn by the IRB and not included in the efficacy analysis. | Posted | Number | percentage of restorations | 6 months post restoration | Restorations | Restorations |
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| Secondary | Fracture of Restorative Material | Fractures on study teeth graded on a 0-4 grading scale with a score of 1 being Excellent/very good and a score of 4 being Unsatisfactory. Grading scale is based on modified FDI World Dental Federation criteria. Scoring categories for the fracture of restorative material are defined as follows:
| Four (4) of 31 subjects did not complete the 6-month visit. One (1) subject withdrawn by the IRB was not included in efficacy analyses | Posted | Number | percentage of restorations | 6 months post-restoration | Restorations | Restorations |
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| Secondary | Secondary Caries | Secondary caries in study teeth scored on scale 1-5.
| Four (4) of 31 subjects did not complete the 6-month visit. One (1) subject withdrawn by the IRB was not included in efficacy analyses | Posted | Number | percentage of restorations | 6 months post-restoration | Restorations | Restorations |
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| Secondary | Retention of Restorative Material | The percentage of restorations with partial or complete loss of the restoration material. | Results were imputed for missing data in the full analysis set. One (1) subject withdrawn by the IRB was not included in the efficacy analysis. | Posted | Number | percentage of restorations | 12 months post-restoration | Restorations | Restorations |
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| Secondary | Marginal Adaptation | Marginal adaptation of restorations graded on a scale of 1-5 with a score of 1 being Excellent/very good and a score of 5 being Poor. Grading scale is based on modified FDI World Dental Federation criteria. Scoring categories for marginal adaptation:
| Ten (10) of 31 subjects did not return for the 12-month visit. One (1) subject withdrawn by the IRB was not included in the efficacy analysis. | Posted | Number | percentage of restorations | 12 months post-restoration | Restorations | Restorations |
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| Secondary | Fracture of Restorative Material | Fractures on study teeth graded on a 1-4 grading scale with a score of 1 being Excellent/very good and a score of 4 being Unsatisfactory. Grading scale is based on modified FDI World Dental Federation criteria. Scoring categories for the fracture of restorative material are defined as follows:
| Ten (10) of 31 subjects did not return for the 12-month visit. One (1) subject withdrawn by the IRB was not included in the efficacy analysis. | Posted | Number | percentage of restorations | 12 months post-restoration | Restorations | Restorations |
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| Secondary | Secondary Caries | Secondary caries in study teeth graded on a 1-5 grading scale with a score of 1 being Excellent/very good and a score of 5 being Poor. Grading scale is based on modified FDI World Dental Federation criteria. Scoring categories for secondary caries are defined as follows.
| Ten (10) of 31 subjects did not return for the 12-month visit. One (1) subject withdrawn by the IRB was not included in the efficacy analysis. | Posted | Number | percentage of restorations | 12 months post-restoration | Restorations | Restorations |
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| Secondary | Fracture of Restorative Material | Fractures on study teeth graded on a 1-4 grading scale with a score of 1 being Excellent/very good and a score of 4 being Unsatisfactory. Grading scale is based on modified FDI World Dental Federation criteria. Scoring categories for the fracture of restorative material are defined as follows:
| Eight (8) of 31 subjects did not complete the 24-month visit. One (1) subject withdrawn by the IRB was not included in efficacy analyses. | Posted | Number | percentage of restorations | 24 months post-restoration | Restorations | Restorations |
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| Secondary | Secondary Caries | Secondary caries in study teeth graded on a 1-5 grading scale with a score of 1 being Excellent/very good and a score of 5 being Poor. Grading scale is based on modified FDI World Dental Federation criteria. Scoring categories for secondary caries are defined as follows.
| Eight (8) of 31 subjects did not complete the 24-month visit. One (1) subject withdrawn by the IRB was not included in efficacy analyses. | Posted | Number | percentage of restorations | 24 months post-restoration | Restorations | Restorations |
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All device-related and serious adverse events were collected from the time of restoration through the 24-month follow-up visit. Non-serious, non-device related adverse events were collected from the time of restoration through the 6-month follow-up visit.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SBU+ Treatment Group | Either 1 tooth (for Subjects with 2 eligible teeth) or 2 teeth (for Subjects with 4 eligible teeth) with Class-V NCCLs will undergo restoration(s) using Scotchbond Universal Plus (SBU+) Adhesive . Scotchbond Universal Plus Adhesive: Eligible teeth with Class-V NCCLs randomized to the SBU+ treatment group will undergo restoration(s) using Scotchbond Universal Plus (SBU+) Adhesive using total-etch mode and Filtek Universal Restorative material. | 0 | 32 | 2 | 32 | 2 | 32 |
| EG001 | SBU Control Group | Either 1 tooth (for Subjects with 2 eligible teeth) or 2 teeth (for Subjects with 4 eligible teeth) with Class-V NCCLs will undergo restoration(s) using the predicate device, Scotchbond Universal (SBU) Adhesive. Scotchbond Universal Adhesive: Eligible teeth with Class-V NCCLs randomized to the SBU Control group will undergo restoration(s) using Scotchbond Universal Plus (SBU) Adhesive using total-etch mode and Filtek Universal Restorative material. | 0 | 32 | 2 | 32 | 2 | 32 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Small cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v24.1 | Systematic Assessment | Small cell carcinoma, not device related |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA v24.1 | Systematic Assessment | worsening of osteoarthritis, not device related |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gingivitis | Gastrointestinal disorders | MedDRA v24.1 | Systematic Assessment | gingiva inflammation, not device related |
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| Gingival blister | Gastrointestinal disorders | MedDRA v24.1 | Systematic Assessment | cold sore-like discomfort near gum tissue, not device related |
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There was a larger than expected amount of attrition during this study, resulting in fewer teeth assessed at the primary 2-year data than anticipated. With higher attrition, the precision of the estimates of the primary results is less than anticipated with slightly wider 95% confidence intervals. Additionally, there is a chance of attrition bias, where the characteristics of the participants who leave the study differ from those who remain.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release for a period up to 90 days and can embargo communications regarding trial results for up to 6 months in case of objections to work out mutually acceptable modifications. The sponsor cannot require changes to the communication and cannot extend the embargo.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paula Myhre | Solventum US LLC | 6513948069 | pemyhre1@solventum.com |
| Feb 26, 2026 |
| Prot_SAP_000.pdf |
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| Between 18 - 65 years |
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| >=65 years |
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| Male |
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| Race: Black or African American |
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| Race: White |
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| Ethnicity: Hispanic or Latino |
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| Ethnicity: Not Hispanic or Latino |
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| Ethnicity: Unknown or Not Reported |
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Either 1 tooth (for Subjects with 2 eligible teeth) or 2 teeth (for Subjects with 4 eligible teeth) with Class-V NCCLs will undergo restoration(s) using the predicate device, Scotchbond Universal (SBU) Adhesive. Scotchbond Universal Adhesive: Eligible teeth with Class-V NCCLs randomized to the SBU Control group will undergo restoration(s) using Scotchbond Universal Plus (SBU) Adhesive using total-etch mode and Filtek Universal Restorative material. |
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| Units | Counts |
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Either 1 tooth (for Subjects with 2 eligible teeth) or 2 teeth (for Subjects with 4 eligible teeth) with Class-V NCCLs will undergo restoration(s) using the predicate device, Scotchbond Universal (SBU) Adhesive.
Scotchbond Universal Adhesive: Eligible teeth with Class-V NCCLs randomized to the SBU Control group will undergo restoration(s) using Scotchbond Universal Plus (SBU) Adhesive using total-etch mode and Filtek Universal Restorative material.
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| Units | Counts |
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| Restorations |
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Either 1 tooth (for Subjects with 2 eligible teeth) or 2 teeth (for Subjects with 4 eligible teeth) with Class-V NCCLs will undergo restoration(s) using the predicate device, Scotchbond Universal (SBU) Adhesive.
Scotchbond Universal Adhesive: Eligible teeth with Class-V NCCLs randomized to the SBU Control group will undergo restoration(s) using Scotchbond Universal Plus (SBU) Adhesive using total-etch mode and Filtek Universal Restorative material.
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