Trial Outcomes & Findings for Clinical Evaluation of a New Flowable and a New Sculptable Universal Bulk-fill Composite for Direct Restorative Treatment (NCT NCT06369779)

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

65 participants

Primary outcome timeframe

1 month

Results posted on

2025-10-23

Participant Flow

Unit of analysis: Restorations

Participant milestones

Participant milestones
Measure	Test group (TM Fill in combination with TM Flow) TM Fill an TM Flow are used for restoration of class I and class II cavities TM Fill in combination with TM Flow: The newly developed resin composites (TM Flow in combination with TM Fill) will be used for the restoration of class I and II cavities (3 seconds light-curing mode, 3000 milliwatt per square centimeter).
Overall Study STARTED	65 65
Overall Study COMPLETED	64 64
Overall Study NOT COMPLETED	1 1

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 group (TM Fill in combination with TM Flow) n=65 Participants TM Fill an TM Flow are used for restoration of class I and class II cavities TM Fill in combination with TM Flow: The newly developed resin composites (TM Flow in combination with TM Fill) will be used for the restoration of class I and II cavities (3 seconds light-curing mode, 3000 milliwatt per square centimeter).
Age, Categorical <=18 years	0 Participants n=65 Participants
Age, Categorical Between 18 and 65 years	65 Participants n=65 Participants
Age, Categorical >=65 years	0 Participants n=65 Participants
Sex: Female, Male Female	27 Participants n=65 Participants
Sex: Female, Male Male	38 Participants n=65 Participants

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 group (TM Fill in combination with TM Flow) n=64 Restorations TM Fill an TM Flow are used for restoration of class I and class II cavities TM Fill in combination with TM Flow: The newly developed resin composites (TM Flow in combination with TM Fill) will be used for the restoration of class I and II cavities (3 seconds light-curing mode, 3000 milliwatt per square centimeter).
Postoperative Hypersensitivity FDI Score 1	63 Restorations
Postoperative Hypersensitivity FDI Score 2	0 Restorations
Postoperative Hypersensitivity FDI Score 3	1 Restorations
Postoperative Hypersensitivity FDI Score 4-5	0 Restorations

SECONDARY outcome

Timeframe: 5 years

will be assessed according to FDI criteria (grade 1-5)

Outcome measures

Outcome data not reported

Adverse Events

Test group (TM Fill in combination with TM Flow)

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