Trial Outcomes & Findings for Clinical Evaluation of a New Dual-cure Universal Adhesive (NCT NCT06615544)

Results Overview

will be assessed according to FDI criteria (grade 1-5, lower scores mean a better outcome)

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

NA

Target enrollment

45 participants

Primary outcome timeframe

1 month

Results posted on

2025-10-23

Participant Flow

Unit of analysis: Restorations

Participant milestones

Participant milestones
Measure	New dual-cure adhesive The newly developed dual-cure adhesive will be used for the placement of indirect restorations. Placement of indirect dental restoration: The newly developed dual-cure adhesive will be used for the placement of indirect restorations.
Overall Study STARTED	45 48
Overall Study COMPLETED	45 47
Overall Study NOT COMPLETED	0 1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Evaluation of a New Dual-cure Universal Adhesive

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	New dual-cure adhesive n=47 Restorations The newly developed dual-cure adhesive will be used for the placement of indirect restorations. Placement of indirect dental restoration: The newly developed dual-cure adhesive will be used for the placement of indirect restorations.
Age, Categorical <=18 years	0 Participants n=45 Participants
Age, Categorical Between 18 and 65 years	45 Participants n=45 Participants
Age, Categorical >=65 years	0 Participants n=45 Participants
Sex: Female, Male Female	15 Participants n=45 Participants
Sex: Female, Male Male	30 Participants n=45 Participants

PRIMARY outcome

Timeframe: 1 month

Population: One patient was not able to visit 1-month recall (no-show)

will be assessed according to FDI criteria (grade 1-5, lower scores mean a better outcome)

Outcome measures

Outcome measures
Measure	New dual-cure adhesive n=46 Restorations The newly developed dual-cure adhesive will be used for the placement of indirect restorations. Placement of indirect dental restoration: The newly developed dual-cure adhesive will be used for the placement of indirect restorations.
Postoperative Hypersensitivity FDI Score 1	46 Restorations
Postoperative Hypersensitivity FDI Score 2-5	0 Restorations

SECONDARY outcome

Timeframe: 5 years

will be assessed according to FDI criteria (grade 1-5, lower scores mean a better outcome)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5 years

will be assessed according to FDI criteria (grade 1-5, lower scores mean a better outcome)

Outcome measures

Outcome data not reported

Adverse Events

New dual-cure adhesive

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	New dual-cure adhesive n=45 participants at risk The newly developed dual-cure adhesive will be used for the placement of indirect restorations. Placement of indirect dental restoration: The newly developed dual-cure adhesive will be used for the placement of indirect restorations.
General disorders Unrealated: Cementation Mistake	4.4% 2/45 • 1-Month

Additional Information

Head of Department Study Management

Ivoclar Vivadent AG

Phone: +4232353780

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place