Trial Outcomes & Findings for Split-mouth Study of a New Flowable Composite in Non-carious Cervical Lesions (NCT NCT06238999)

Results Overview

assessed by tests with thermal stimuli and occlusal forces (during biting) determined by VAS (Visual Analog Scale, 0 "No pain at all" - 10 "The worst pain imaginable") following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable" FDI 1: no complaint FDI 2: minor complaint FDI 3: distinct pain FDI 4: persistent pain for prolonged period of time FDI 5: treatment unavoidable

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

NA

Target enrollment

66 participants

Primary outcome timeframe

1 month

Results posted on

2025-10-23

Participant Flow

Unit of analysis: Teeth

Participant milestones

Participant milestones
Measure	Test goup TM Flow The newly developed flowable composite TM Flow will be used for the restoration of NCCLs in the test group. The treatment workflow is very similar to other flowable composites. Restoration of non-carious cervical lesions: Non-carious cervical lesions will be treated with the experimental TM Flow or the well-established Tetric EvoFlow. The treatment workflow is very similar to other flowable composites.	Control group Tetric EvoFlow The well-established Tetric EvoFlow will be used for the restorations of NCCLs in the control group. Restoration of non-carious cervical lesions: Non-carious cervical lesions will be treated with the experimental TM Flow or the well-established Tetric EvoFlow. The treatment workflow is very similar to other flowable composites.
Overall Study STARTED	66 66	66 66
Overall Study COMPLETED	66 66	66 66
Overall Study NOT COMPLETED	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Test goup TM Flow n=66 Teeth The newly developed flowable composite TM Flow will be used for the restoration of NCCLs in the test group. The treatment workflow is very similar to other flowable composites. Restoration of non-carious cervical lesions: Non-carious cervical lesions will be treated with the experimental TM Flow or the well-established Tetric EvoFlow. The treatment workflow is very similar to other flowable composites.	Control group Tetric EvoFlow n=66 Teeth The well-established Tetric EvoFlow will be used for the restorations of NCCLs in the control group. Restoration of non-carious cervical lesions: Non-carious cervical lesions will be treated with the experimental TM Flow or the well-established Tetric EvoFlow. The treatment workflow is very similar to other flowable composites.	Total n=132 Teeth Total of all reporting groups
Age, Customized <= 18 years	0 Participants n=66 Participants	0 Participants n=66 Participants	0 Participants n=66 Participants
Age, Customized 18 to 65 years	66 Participants n=66 Participants	66 Participants n=66 Participants	66 Participants n=66 Participants
Age, Customized > 65 years	0 Participants n=66 Participants	0 Participants n=66 Participants	0 Participants n=66 Participants
Sex/Gender, Customized Female	15 Participants n=66 Participants	15 Participants n=66 Participants	15 Participants n=66 Participants
Sex/Gender, Customized Male	51 Participants n=66 Participants	51 Participants n=66 Participants	51 Participants n=66 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 1 month

assessed by tests with thermal stimuli and occlusal forces (during biting) determined by VAS (Visual Analog Scale, 0 "No pain at all" - 10 "The worst pain imaginable") following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable" FDI 1: no complaint FDI 2: minor complaint FDI 3: distinct pain FDI 4: persistent pain for prolonged period of time FDI 5: treatment unavoidable

Outcome measures

Outcome measures
Measure	Test goup TM Flow n=66 Teeth The newly developed flowable composite TM Flow will be used for the restoration of NCCLs in the test group. The treatment workflow is very similar to other flowable composites. Restoration of non-carious cervical lesions: Non-carious cervical lesions will be treated with the experimental TM Flow or the well-established Tetric EvoFlow. The treatment workflow is very similar to other flowable composites.	Control group Tetric EvoFlow n=66 Teeth The well-established Tetric EvoFlow will be used for the restorations of NCCLs in the control group. Restoration of non-carious cervical lesions: Non-carious cervical lesions will be treated with the experimental TM Flow or the well-established Tetric EvoFlow. The treatment workflow is very similar to other flowable composites.
Postoperative Hypersensitivity FDI Score 2-5	0 Teeth	0 Teeth
Postoperative Hypersensitivity FDI Score 1	66 Teeth	66 Teeth

SECONDARY outcome

Timeframe: 5 years

will be assessed acooriding to FDI criteria

Outcome measures

Outcome data not reported

Adverse Events

Test goup TM Flow

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control group Tetric EvoFlow

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Team Leader Study Management

Ivoclar Vivadent AG

Phone: +4232353780

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place