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| Name | Class |
|---|---|
| Ivoclar Vivadent AG | INDUSTRY |
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The purpose of this prospective clinical trial will be to evaluate the efficacy of an FDA approved and marketed universal dental adhesive formulation in adult noncarious cervical lesions using self-etch and selective etch approaches.
The hypothesis is that using a selective enamel etch with this universal adhesive will enhance the restoration margin performance.
The purpose of this prospective clinical trial will be to evaluate the efficacy of a newly formulated universal dental adhesive formulation in adult noncarious cervical lesions using self-etch and selective etch approaches.
Thirty-three patients with at least two non-carious cervical lesions will receive one restoration utilizing the self-etch universal adhesive with no separate enamel etching and another restoration utilizing the universal adhesive and a a selective etch protocol in which in which enamel is etched with 37% phosphoric acid.
After a screening/baseline visit at which the restorative procedures listed above will conducted, the patient will be seen at recall visits after approximately 6, 12 and 24 months to observe sensitivity, retention, marginal discoloration and marginal adaptation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adhese Universal with self etch enamel etching | Active Comparator | patients will receive one restoration on randomly selected study tooth utilizing the self-etch universal adhesive (Adhese Universal, Ivoclar Vivadent) with no separate enamel etching |
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| selective etch protocol followed by Adhese Universal | Experimental | patients will receive one restoration on randomly selected study tooth utilizing a 37% phosphoric acid solution followed by application of self-etch universal adhesive (Adhese Universal, Ivoclar Vivadent) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Self etch enamel etching | Procedure | The adhesive will be applied according to manufacturer's instructions. If the lesion is greater than 2 mm in any dimension, incremental placement of Tetric EvoCeram composite (Ivoclar Vivadent) will occur with the first increment being placed against enamel. |
| Measure | Description | Time Frame |
|---|---|---|
| Retention of Restorations | The primary outcome measure will be restoration retention. In these non-retentive dental lesions, the adhesive will be the only mode of retention. Failure of the adhesive would result in loss of the restoration. | 6, 12, 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Restoration Margins Marked as Stained or Discolored | The secondary outcome measure was the presence of discoloration of restoration margins as determined by blinded evaluators. | 6, 12, 24 months |
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Inclusion Criteria:
1.1. Inclusion criteria
Willing to provide written consent and authorization for participation.
Be between 20 and 75 years of age at the time of recruitment
Have at least two non-carious cervical lesions present in canine or premolar teeth;
Anticipates availability for recalls (roughly 6 month, 12 month, and 24 month) through the two-year study period
The lesions selected will be at least 1 mm in depth (measured with a perio probe) and contain both enamel and dentin margins.
Exclusion Criteria:
1.2. Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey A Platt, DDS | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University School of Dentistry | Indianapolis | Indiana | 46202 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Adhese Universal With Self Etch Enamel Etching | patients will receive one restoration on randomly selected study tooth utilizing the self-etch universal adhesive (Adhese Universal, Ivoclar Vivadent) with no separate enamel etching Self etch enamel etching: The adhesive will be applied according to manufacturer's instructions. If the lesion is greater than 2 mm in any dimension, incremental placement of Tetric EvoCeram composite (Ivoclar Vivadent) will occur with the first increment being placed against enamel. Adhese Universal: the universal adhesive, Adhese Universal , will be applied to the selected tooth following manufacturer instructions |
| FG001 | Selective Etch Protocol Followed by Adhese Universal | patients will receive one restoration on randomly selected study tooth utilizing a 37% phosphoric acid solution followed by application of self-etch universal adhesive (Adhese Universal, Ivoclar Vivadent) selective etch protocol: Total Etch (37% phosphoric acid; Ivoclar) will be placed on the enamel margin with no intentional placement on the dentin within the lesion. The adhesive will then be applied as instructed by the manufacturer. Tetric EvoCeram composite will be placed, light-cured, finished, and polished in the same manner as for the self-etch group. Adhese Universal: the universal adhesive, Adhese Universal , will be applied to the selected tooth following manufacturer instructions |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | All participants received both interventions. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| 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 | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Retention of Restorations | The primary outcome measure will be restoration retention. In these non-retentive dental lesions, the adhesive will be the only mode of retention. Failure of the adhesive would result in loss of the restoration. | Available number of participants at each time point are reported. | Posted | Count of Units | Non-carious cervical lesions | 6, 12, 24 months | Non-carious cervical lesions | Non-carious cervical lesions |
|
24 months
Adverse events were not monitored per intervention.
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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 | All Study Participants | Adverse events were not monitored per intervention. | 1 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jeffrey Platt | Indiana University School of Dentistry | 3172747229 | jplatt2@iu.edu |
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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 | Feb 19, 2015 | May 22, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| C092621 | Ivoclar Universal Cement |
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| selective etch protocol | Procedure | Total Etch (37% phosphoric acid; Ivoclar) will be placed on the enamel margin with no intentional placement on the dentin within the lesion. The adhesive will then be applied as instructed by the manufacturer. Tetric EvoCeram composite will be placed, light-cured, finished, and polished in the same manner as for the self-etch group. |
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| Adhese Universal | Device | the universal adhesive, Adhese Universal , will be applied to the selected tooth following manufacturer instructions |
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| Moved out of area |
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| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | Selective Etch Protocol Followed by Adhese Universal | patients will receive one restoration on randomly selected study tooth utilizing a 37% phosphoric acid solution followed by application of self-etch universal adhesive (Adhese Universal, Ivoclar Vivadent) selective etch protocol: Total Etch (37% phosphoric acid; Ivoclar) will be placed on the enamel margin with no intentional placement on the dentin within the lesion. The adhesive will then be applied as instructed by the manufacturer. Tetric EvoCeram composite will be placed, light-cured, finished, and polished in the same manner as for the self-etch group. Adhese Universal: the universal adhesive, Adhese Universal , will be applied to the selected tooth following manufacturer instructions |
|
|
| Secondary | Number of Restoration Margins Marked as Stained or Discolored | The secondary outcome measure was the presence of discoloration of restoration margins as determined by blinded evaluators. | Available number of participants at each time point are reported. | Posted | Count of Units | Non-carious cervical lesions | 6, 12, 24 months | Non-carious cervical lesions | Non-carious cervical lesions |
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| 33 |
| 0 |
| 33 |
| 0 |
| 33 |
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| 12 months |
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| 24 months |
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