Trial Outcomes & Findings for Clinical Investigation of the F-Composite 2 System in Direct Filling Therapy (NCT NCT03221660)

NCT ID: NCT03221660

Last Updated: 2025-04-13

Results Overview

The postoperative sensitivity is assessed by tests with thermal stimuli and occlusal forces (during biting) determined by VAS (Visual Analog Scale, from 0 "no pain" to 10 "maximum pain") following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable". A maximum of 10% postoperative hypersensitivities are defined as acceptable after one month.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 50 participants
• Primary outcome timeframe: 1 month
• Results posted on: 2025-04-13

Participant Flow

Unit of analysis: teeth

Participant milestones

Measure	F-Composite 2 System 75 teeth affected by dental caries or with an existing defective filling were restored using the F-Composite 2 system. 25 participants received two fillings and 25 received only one filling. F-Composite 2 system: Procedures was done using local anesthesia (if the patients wants that). The cavity was prepared according to the principles of the adhesive technique. First the adhesive was applied and polymerized, afterwards the flowable resin-based restorative material was applied and polymerized. Then the sculptable resin-based restorative material was applied and polymerized. All materials were light-cured within short time with an experimental curing light.
Overall Study STARTED	50 75
Overall Study COMPLETED	42 60
Overall Study NOT COMPLETED	8 15

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Investigation of the F-Composite 2 System in Direct Filling Therapy

Baseline characteristics by cohort

Measure	F-Composite 2 System n=75 Teeth 75 teeth affected by dental caries or with an existing defective filling were restored using the F-Composite 2 system. 25 participants received two fillings and 25 received only one filling. F-Composite 2 system: Procedures was done using local anesthesia (if the patients wants that). The cavity was prepared according to the principles of the adhesive technique. First the adhesive was applied and polymerized, afterwards the flowable resin-based restorative material was applied and polymerized. Then the sculptable resin-based restorative material was applied and polymerized. All materials were light-cured within short time with an experimental curing light.
Age, Categorical <=18 years	0 Participants n=50 Participants
Age, Categorical Between 18 and 65 years	50 Participants n=50 Participants
Age, Categorical >=65 years	0 Participants n=50 Participants
Sex: Female, Male Female	18 Participants n=50 Participants
Sex: Female, Male Male	32 Participants n=50 Participants
Region of Enrollment Liechtenstein	75 Teeth n=75 Teeth

PRIMARY outcome

Timeframe: 1 month

The postoperative sensitivity is assessed by tests with thermal stimuli and occlusal forces (during biting) determined by VAS (Visual Analog Scale, from 0 "no pain" to 10 "maximum pain") following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable".

A maximum of 10% postoperative hypersensitivities are defined as acceptable after one month.

Outcome measures

Measure

F-Composite 2 System n=75 Teeth 75 teeth affected by dental caries or with an existing defective filling were restored using the F-Composite 2 system. 25 participants received two fillings and 25 received only one filling. F-Composite 2 system: Procedures was done using local anesthesia (if the patients wants that). The cavity was prepared according to the principles of the adhesive technique. First the adhesive was applied and polymerized, afterwards the flowable resin-based restorative material was applied and polymerized. Then the sculptable resin-based restorative material was applied and polymerized. All materials were light-cured within short time with an experimental curing light.

Percentage of Restored Teeth With Postoperative Sensitivity

7 percentage restored hypersensitive teeth

SECONDARY outcome

Timeframe: 12 months

Population: The participants analyzed and number of teeth (units) analyzed differs from the number of participants and units assigned to the arm as 1 participant with 2 fillings did not attend the 12-month recall.

The loss of vitality of restored teeth is assessed by a cold stimuli test (cotton pellet and refrigerating spray) following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable".

A maximum of 1 tooth with loss of vitality within 12 months is determined to be acceptable.

Outcome measures

Measure

F-Composite 2 System n=73 Teeth 75 teeth affected by dental caries or with an existing defective filling were restored using the F-Composite 2 system. 25 participants received two fillings and 25 received only one filling. F-Composite 2 system: Procedures was done using local anesthesia (if the patients wants that). The cavity was prepared according to the principles of the adhesive technique. First the adhesive was applied and polymerized, afterwards the flowable resin-based restorative material was applied and polymerized. Then the sculptable resin-based restorative material was applied and polymerized. All materials were light-cured within short time with an experimental curing light.

Number of Restored Teeth With Loss of Vitality

0 teeth

SECONDARY outcome

Timeframe: 2 years

maximum of 3 fillings which have to be replaced due to a lack of quality after 2 years

Outcome measures

Measure

F-Composite 2 System n=73 Teeth 75 teeth affected by dental caries or with an existing defective filling were restored using the F-Composite 2 system. 25 participants received two fillings and 25 received only one filling. F-Composite 2 system: Procedures was done using local anesthesia (if the patients wants that). The cavity was prepared according to the principles of the adhesive technique. First the adhesive was applied and polymerized, afterwards the flowable resin-based restorative material was applied and polymerized. Then the sculptable resin-based restorative material was applied and polymerized. All materials were light-cured within short time with an experimental curing light.

Replacement of Filling

0 replaced fillings due to quality

OTHER_PRE_SPECIFIED outcome

Timeframe: 60 months

Population: 7 patients with 12 restorations were not able to attend final recall after 5 years. 3 restorations were replaced because patient suffered from hypersensitivoity on bitting/chewing. 60 from the initial 75 restoratons were analyzed

assessed on patient teeth (comparing surface of filling with enamel) following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"

Outcome measures

Measure	F-Composite 2 System n=60 teeth 75 teeth affected by dental caries or with an existing defective filling were restored using the F-Composite 2 system. 25 participants received two fillings and 25 received only one filling. F-Composite 2 system: Procedures was done using local anesthesia (if the patients wants that). The cavity was prepared according to the principles of the adhesive technique. First the adhesive was applied and polymerized, afterwards the flowable resin-based restorative material was applied and polymerized. Then the sculptable resin-based restorative material was applied and polymerized. All materials were light-cured within short time with an experimental curing light.
FDI 1 Surface Luster, FDI Score 1-5 FDI 1 Surface Luster, FDI Score 4-5	0 Teeth
FDI 1 Surface Luster, FDI Score 1-5 FDI 1 Surface Luster, FDI Score 1	6 Teeth
FDI 1 Surface Luster, FDI Score 1-5 FDI 1 Surface Luster, FDI Score 2	45 Teeth
FDI 1 Surface Luster, FDI Score 1-5 FDI 1 Surface Luster, FDI Score 3	9 Teeth

OTHER_PRE_SPECIFIED outcome

Timeframe: 60 month

Population: 7 patients with 12 restorations were not able to attend final recall after 5 years. 3 restorations were replaced because patient suffered from hypersensitivoity on bitting/chewing. 60 from the initial 75 restoratons were analyzed

assessed on patient teeth by checking surface staining of restoration following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"

Outcome measures

Measure	F-Composite 2 System n=60 Teeth 75 teeth affected by dental caries or with an existing defective filling were restored using the F-Composite 2 system. 25 participants received two fillings and 25 received only one filling. F-Composite 2 system: Procedures was done using local anesthesia (if the patients wants that). The cavity was prepared according to the principles of the adhesive technique. First the adhesive was applied and polymerized, afterwards the flowable resin-based restorative material was applied and polymerized. Then the sculptable resin-based restorative material was applied and polymerized. All materials were light-cured within short time with an experimental curing light.
FDI 2 Surface Staining, FDI Score 1-5 FDI 2 Surface Staining, FDI Score 1	42 teeth
FDI 2 Surface Staining, FDI Score 1-5 FDI 2 Surface Staining, FDI Score 2	17 teeth
FDI 2 Surface Staining, FDI Score 1-5 FDI 2 Surface Staining, FDI Score 3	1 teeth
FDI 2 Surface Staining, FDI Score 1-5 FDI 2 Surface Staining, FDI Score 4-5	0 teeth

OTHER_PRE_SPECIFIED outcome

Timeframe: 60 month

Population: 7 patients with 12 restorations were not able to attend final recall after 5 years. 3 restorations were replaced because patient suffered from hypersensitivoity on bitting/chewing. 60 from the initial 75 restoratons were analyzed

assessed on patient teeth by checking differences in shade and translucency following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"

Outcome measures

Measure	F-Composite 2 System n=60 Teeth 75 teeth affected by dental caries or with an existing defective filling were restored using the F-Composite 2 system. 25 participants received two fillings and 25 received only one filling. F-Composite 2 system: Procedures was done using local anesthesia (if the patients wants that). The cavity was prepared according to the principles of the adhesive technique. First the adhesive was applied and polymerized, afterwards the flowable resin-based restorative material was applied and polymerized. Then the sculptable resin-based restorative material was applied and polymerized. All materials were light-cured within short time with an experimental curing light.
FDI 3 Translucency, FDI Score 1-5 FDI 3 Translucency, FDI Score 1	43 Teeth
FDI 3 Translucency, FDI Score 1-5 FDI 3 Translucency, FDI Score 2	17 Teeth
FDI 3 Translucency, FDI Score 1-5 FDI 3 Translucency, FDI Score 3-5	0 Teeth

OTHER_PRE_SPECIFIED outcome

Timeframe: 60 month

Population: 7 patients with 12 restorations were not able to attend final recall after 5 years. 3 restorations were replaced because patient suffered from hypersensitivoity on bitting/chewing. 60 from the initial 75 restoratons were analyzed

assessed on patient teeth (checking irestorations for fractures, cracks, small hairline cracks, chip fractures, material damage) following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"

Outcome measures

Measure	F-Composite 2 System n=60 Teeth 75 teeth affected by dental caries or with an existing defective filling were restored using the F-Composite 2 system. 25 participants received two fillings and 25 received only one filling. F-Composite 2 system: Procedures was done using local anesthesia (if the patients wants that). The cavity was prepared according to the principles of the adhesive technique. First the adhesive was applied and polymerized, afterwards the flowable resin-based restorative material was applied and polymerized. Then the sculptable resin-based restorative material was applied and polymerized. All materials were light-cured within short time with an experimental curing light.
FDI 5 Retention/Fracture of Restorations, FDI Score 1-5 FDI 5 Fracture of material and retention, FDI Score 1	51 Teeth
FDI 5 Retention/Fracture of Restorations, FDI Score 1-5 FDI 5 Fracture of material and retention, FDI Score 2	4 Teeth
FDI 5 Retention/Fracture of Restorations, FDI Score 1-5 FDI 5 Fracture of material and retention, FDI Score 3	5 Teeth
FDI 5 Retention/Fracture of Restorations, FDI Score 1-5 FDI 5 Fracture of material and retention, FDI Score 4-5	0 Teeth

OTHER_PRE_SPECIFIED outcome

Timeframe: 60 month

Population: 7 patients with 12 restorations were not able to attend final recall after 5 years. 3 restorations were replaced because patient suffered from hypersensitivoity on bitting/chewing. 60 from the initial 75 restoratons were analyzed

assessed on patient teeth (checking for hamonious outline, gaps and white/discolored lines)) following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"

Outcome measures

Measure	F-Composite 2 System n=60 Teeth 75 teeth affected by dental caries or with an existing defective filling were restored using the F-Composite 2 system. 25 participants received two fillings and 25 received only one filling. F-Composite 2 system: Procedures was done using local anesthesia (if the patients wants that). The cavity was prepared according to the principles of the adhesive technique. First the adhesive was applied and polymerized, afterwards the flowable resin-based restorative material was applied and polymerized. Then the sculptable resin-based restorative material was applied and polymerized. All materials were light-cured within short time with an experimental curing light.
FDI 6 Marginal Adaption, FDI Score 1-5 FDI 6 Marginal Gap, FDI Score 1	49 Teeth
FDI 6 Marginal Adaption, FDI Score 1-5 FDI 6 Marginal Gap, FDI Score 2	9 Teeth
FDI 6 Marginal Adaption, FDI Score 1-5 FDI 6 Marginal Gap, FDI Score 3	2 Teeth
FDI 6 Marginal Adaption, FDI Score 1-5 FDI 6 Marginal Gap, FDI Score 4-5	0 Teeth

OTHER_PRE_SPECIFIED outcome

Timeframe: 60 month

Population: 7 patients with 12 restorations were not able to attend final recall after 5 years. 3 restorations were replaced because patient suffered from hypersensitivoity on bitting/chewing. 60 from the initial 75 restoratons were analyzed

assessed by discussion with the patient (satisfied with esthetics and function) following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"

Outcome measures

Measure	F-Composite 2 System n=60 Teeth 75 teeth affected by dental caries or with an existing defective filling were restored using the F-Composite 2 system. 25 participants received two fillings and 25 received only one filling. F-Composite 2 system: Procedures was done using local anesthesia (if the patients wants that). The cavity was prepared according to the principles of the adhesive technique. First the adhesive was applied and polymerized, afterwards the flowable resin-based restorative material was applied and polymerized. Then the sculptable resin-based restorative material was applied and polymerized. All materials were light-cured within short time with an experimental curing light.
FDI 10 Patient's View, FDI Scire 1-5 FDI 10 Patient's View, FDI Score 1	60 Teeth
FDI 10 Patient's View, FDI Scire 1-5 FDI 10 Patient's View, FDI Score 2-5	0 Teeth

OTHER_PRE_SPECIFIED outcome

Timeframe: 60 month

Population: 7 patients with 12 restorations were not able to attend final recall after 5 years. 3 restorations were replaced because patient suffered from hypersensitivoity on bitting/chewing. 60 from the initial 75 restoratons were analyzed

Hypersensitivity was assessed by tests with thermal stimuli and occlusal forces (during biting) determined by VAS (Visual Analog Scale) following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable".

Tooth vtality assessed by a cold stimuli test on the patient teeth (cotton pellet and refrigerating spray) following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"

Outcome measures

Measure	F-Composite 2 System n=60 Teeth 75 teeth affected by dental caries or with an existing defective filling were restored using the F-Composite 2 system. 25 participants received two fillings and 25 received only one filling. F-Composite 2 system: Procedures was done using local anesthesia (if the patients wants that). The cavity was prepared according to the principles of the adhesive technique. First the adhesive was applied and polymerized, afterwards the flowable resin-based restorative material was applied and polymerized. Then the sculptable resin-based restorative material was applied and polymerized. All materials were light-cured within short time with an experimental curing light.
FDI 11 Postoperative Hypersensitivity and Tooth Vitality, FDI Scores 1-5 FDI 11 Postoperative hypersensitivity and tooth vitality, FDI Score 1	60 Teeth
FDI 11 Postoperative Hypersensitivity and Tooth Vitality, FDI Scores 1-5 FDI 11 Postoperative hypersensitivity and tooth vitality, FDI Score 2-5	0 Teeth

OTHER_PRE_SPECIFIED outcome

Timeframe: 60 month

Population: 7 patients with 12 restorations were not able to attend final recall after 5 years. 3 restorations were replaced because patient suffered from hypersensitivoity on bitting/chewing. 60 from the initial 75 restoratons were analyzed

assessed on patient teeth (primary caries, areas of demineralization erosion or abfraction)) following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"

Outcome measures

Measure	F-Composite 2 System n=60 Teeth 75 teeth affected by dental caries or with an existing defective filling were restored using the F-Composite 2 system. 25 participants received two fillings and 25 received only one filling. F-Composite 2 system: Procedures was done using local anesthesia (if the patients wants that). The cavity was prepared according to the principles of the adhesive technique. First the adhesive was applied and polymerized, afterwards the flowable resin-based restorative material was applied and polymerized. Then the sculptable resin-based restorative material was applied and polymerized. All materials were light-cured within short time with an experimental curing light.
FDI 12 Recurrence of Caries (CAR), Erosion, Abfraction, FDI Scores 1-5 FDI 12 Recurrence of Caries (CAR), erosion, abfraction, FDI Score 1	59 Teeth
FDI 12 Recurrence of Caries (CAR), Erosion, Abfraction, FDI Scores 1-5 FDI 12 Recurrence of Caries (CAR), erosion, abfraction, FDI Score 2	1 Teeth
FDI 12 Recurrence of Caries (CAR), Erosion, Abfraction, FDI Scores 1-5 FDI 12 Recurrence of Caries (CAR), erosion, abfraction, FDI Score 3-5	0 Teeth

OTHER_PRE_SPECIFIED outcome

Timeframe: 60 month

Population: 7 patients with 12 restorations were not able to attend final recall after 5 years. 3 restorations were replaced because patient suffered from hypersensitivoity on bitting/chewing. 60 from the initial 75 restoratons were analyzed

assessed on patient teeth by checking tooth integrity (looking for enamel cracks, tooth fractures) following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"

Outcome measures

Measure	F-Composite 2 System n=60 Teeth 75 teeth affected by dental caries or with an existing defective filling were restored using the F-Composite 2 system. 25 participants received two fillings and 25 received only one filling. F-Composite 2 system: Procedures was done using local anesthesia (if the patients wants that). The cavity was prepared according to the principles of the adhesive technique. First the adhesive was applied and polymerized, afterwards the flowable resin-based restorative material was applied and polymerized. Then the sculptable resin-based restorative material was applied and polymerized. All materials were light-cured within short time with an experimental curing light.
FDI 13 Tooth Integrity, FDI Scores 1-5 FDI 13 Tooth integrity, FDI Score 5	1 Teeth
FDI 13 Tooth Integrity, FDI Scores 1-5 FDI 13 Tooth integrity, FDI Score 1	58 Teeth
FDI 13 Tooth Integrity, FDI Scores 1-5 FDI 13 Tooth integrity, FDI Score 2-3	0 Teeth
FDI 13 Tooth Integrity, FDI Scores 1-5 FDI 13 Tooth integrity, FDI Score 4	1 Teeth

Adverse Events

F-Composite 2 System

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	F-Composite 2 System n=50 participants at risk Tooth (teeth) affected by dental caries or with an existing defective filling will be restored using the F-Composite 2 system. F-Composite 2 system: Procedures will be done using local anesthesia (if the patients wants that). The cavity is prepared according to the principles of the adhesive technique. First the adhesive will be applied and polymerized, afterwards the flowable resin-based restorative material will be applied and polymerized and then the sculptable resin-based restorative material will be applied and polymerized; all materials will be light-cured within short time with an experimental curing light.
General disorders Long-term hypersensitivity	6.0% 3/50 • Number of events 3 • 12 months
General disorders Unrelated: Fracture of disto-lingual cusp next to study tooth	2.0% 1/50 • Number of events 1 • 12 months

Additional Information

Dr. med. dent. Lukas Enggist, Dentist internal clinic (Principal Investigator)

Ivoclar Vivadent AG

Phone: +423 235 34 46

Email: lukas.enggist@ivoclarvivadent.com

Results disclosure agreements

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