Cervical Lesions
Conditions
Keywords
noncarious cervical lesions, dental adhesive, retention, enamel margin discoloration, self etch, selective etch procedures
Brief summary
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.
Detailed description
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.
Interventions
PROCEDURESelf 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.
PROCEDUREselective 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.
DEVICEAdhese Universal
the universal adhesive, Adhese Universal , will be applied to the selected tooth following manufacturer instructions
Sponsors
Ivoclar Vivadent AG
Indiana University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* 1.1. Inclusion criteria 1. Willing to provide written consent and authorization for participation. 2. Be between 20 and 75 years of age at the time of recruitment 3. Have at least two non-carious cervical lesions present in canine or premolar teeth; 4. Anticipates availability for recalls (roughly 6 month, 12 month, and 24 month) through the two-year study period 5. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Retention of Restorations | 6, 12, 24 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Restoration Margins Marked as Stained or Discolored | 6, 12, 24 months | The secondary outcome measure was the presence of discoloration of restoration margins as determined by blinded evaluators. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants All participants received both interventions. | 33 |
| Total | 33 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 1 |
| Overall Study | Lost to Follow-up | 4 | 4 |
| Overall Study | Moved out of area | 1 | 1 |
Baseline characteristics
| Characteristic | All Study Participants | — |
|---|---|---|
| Age, Customized 20-39 | 4 Participants | — |
| Age, Customized 40-59 | 14 Participants | — |
| Age, Customized 60+ | 15 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 33 participants | — |
| Sex: Female, Male Female | 16 Participants | — |
| Sex: Female, Male Male | 17 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 33 |
| other Total, other adverse events | 0 / 33 |
| serious Total, serious adverse events | 0 / 33 |
Outcome results
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.
Time frame: 6, 12, 24 months
Population: Available number of participants at each time point are reported.
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Adhese Universal With Self Etch Enamel Etching | Retention of Restorations | 12 months | 37 Non-carious cervical lesions |
| Adhese Universal With Self Etch Enamel Etching | Retention of Restorations | 6 months | 38 Non-carious cervical lesions |
| Adhese Universal With Self Etch Enamel Etching | Retention of Restorations | 24 months | 34 Non-carious cervical lesions |
| Selective Etch Protocol Followed by Adhese Universal | Retention of Restorations | 12 months | 37 Non-carious cervical lesions |
| Selective Etch Protocol Followed by Adhese Universal | Retention of Restorations | 6 months | 38 Non-carious cervical lesions |
| Selective Etch Protocol Followed by Adhese Universal | Retention of Restorations | 24 months | 31 Non-carious cervical lesions |
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.
Time frame: 6, 12, 24 months
Population: Available number of participants at each time point are reported.
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Adhese Universal With Self Etch Enamel Etching | Number of Restoration Margins Marked as Stained or Discolored | 24 months | 5 Non-carious cervical lesions |
| Adhese Universal With Self Etch Enamel Etching | Number of Restoration Margins Marked as Stained or Discolored | 6 months | 1 Non-carious cervical lesions |
| Adhese Universal With Self Etch Enamel Etching | Number of Restoration Margins Marked as Stained or Discolored | 12 months | 0 Non-carious cervical lesions |
| Selective Etch Protocol Followed by Adhese Universal | Number of Restoration Margins Marked as Stained or Discolored | 24 months | 1 Non-carious cervical lesions |
| Selective Etch Protocol Followed by Adhese Universal | Number of Restoration Margins Marked as Stained or Discolored | 6 months | 1 Non-carious cervical lesions |
| Selective Etch Protocol Followed by Adhese Universal | Number of Restoration Margins Marked as Stained or Discolored | 12 months | 0 Non-carious cervical lesions |