Trial Outcomes & Findings for Clinical Evaluation of a Universal Adhesive in Noncarious Cervical Lesions (NCT NCT02172664)

NCT ID: NCT02172664

Last Updated: 2019-05-28

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 33 participants
• Primary outcome timeframe: 6, 12, 24 months
• Results posted on: 2019-05-28

Participant Flow

Unit of analysis: Non-carious cervical lesions

Participant milestones

Measure	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	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
Overall Study STARTED	33 40	33 41
Overall Study COMPLETED	27 35	27 31
Overall Study NOT COMPLETED	6 5	6 10

Reasons for withdrawal

Measure	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	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
Overall Study Lost to Follow-up	4	4
Overall Study Death	1	1
Overall Study Moved out of area	1	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	All Study Participants n=33 Participants All participants received both interventions.
Age, Customized 20-39	4 Participants n=33 Participants
Age, Customized 40-59	14 Participants n=33 Participants
Age, Customized 60+	15 Participants n=33 Participants
Sex: Female, Male Female	16 Participants n=33 Participants
Sex: Female, Male Male	17 Participants n=33 Participants
Region of Enrollment United States	33 participants n=33 Participants

PRIMARY outcome

Timeframe: 6, 12, 24 months

Population: Available number of participants at each time point are reported.

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.

Outcome measures

Measure	Adhese Universal With Self Etch Enamel Etching n=40 Non-carious cervical lesions 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	Selective Etch Protocol Followed by Adhese Universal n=41 Non-carious cervical lesions 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
Retention of Restorations 12 months	37 Non-carious cervical lesions	37 Non-carious cervical lesions
Retention of Restorations 6 months	38 Non-carious cervical lesions	38 Non-carious cervical lesions
Retention of Restorations 24 months	34 Non-carious cervical lesions	31 Non-carious cervical lesions

SECONDARY outcome

Timeframe: 6, 12, 24 months

Population: Available number of participants at each time point are reported.

The secondary outcome measure was the presence of discoloration of restoration margins as determined by blinded evaluators.

Outcome measures

Measure	Adhese Universal With Self Etch Enamel Etching n=40 Non-carious cervical lesions 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	Selective Etch Protocol Followed by Adhese Universal n=41 Non-carious cervical lesions 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
Number of Restoration Margins Marked as Stained or Discolored 6 months	1 Non-carious cervical lesions	1 Non-carious cervical lesions
Number of Restoration Margins Marked as Stained or Discolored 12 months	0 Non-carious cervical lesions	0 Non-carious cervical lesions
Number of Restoration Margins Marked as Stained or Discolored 24 months	5 Non-carious cervical lesions	1 Non-carious cervical lesions

Adverse Events

All Study Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jeffrey Platt

Indiana University School of Dentistry

Phone: 3172747229

Email: jplatt2@iu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place