Dental Caries, Unsatisfactory or Defective Restoration of Tooth
Conditions
Keywords
filling material, polymerization
Brief summary
The objective of this study is to evaluate the clinical performance of F-Composite 2 system in Class I and Class II cavities in permanent teeth. The materials of the system can be polymerized in short time with a curing light which is part of the system. The study will be carried out as a prospective study, with evaluation of the restorations after 7-10 days (baseline), at 6 months, at 12 months, at 24 months and 60 months according to defined criteria.
Interventions
DEVICEF-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.
Sponsors
Ivoclar Vivadent AG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Indication for direct filling of Class I or II with permanent premolars or permanent molars * replacement of insufficient fillings (e.g., due to edge caries, filling fracture, Lack of quality of the surface, lack of aesthetics, undesirable filling material, leaky edge, edge gap, etc.) * extensive primary caries * Vital tooth (cold test) * One-, two- or three-surface fillings in the lateral tooth area, with a maximum of 25% single-faced (Class I) with antagonists. * The occlusal area of the filling must be at least 1/3 of the total area of the filling tooth. This criterion is estimated. * Patient wishes to receive care within the framework of the study (written consent after detailed elucidation and study of patient information). * Maximum of 2 restorations per patient. * Preoperative complaints on the tooth to be restored (maximum 3 on visual Analog scale (0 = complaint-free, 10 = maximum possible pain) to temperature or bite sensitivity * Sufficient language skills
Exclusion criteria
* Unfinished hygiene phase or poor oral hygiene * Sufficient draining of the operating field is not possible * Patients with proven allergy to one of the ingredients of the materials used * Patient has allergies to local anesthetic agents Ultracain DS (active substance: articaine; Vasoconstrictor), if anesthesia is desired * Patients with severe systemic diseases * Devital or pulpitic teeth * Periodontal insufficiency * Supplements with cusp attachments * open side bite * missing antagonist * Indication for direct capping * Pregnancy (women of childbearing age receive a free pregnancy test for self application, the negative result of which is shown with her confirmed consent).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Restored Teeth With Postoperative Sensitivity | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Restored Teeth With Loss of Vitality | 12 months | 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. |
| Replacement of Filling | 2 years | maximum of 3 fillings which have to be replaced due to a lack of quality after 2 years |
Other
| Measure | Time frame | Description |
|---|---|---|
| FDI 5 Retention/Fracture of Restorations, FDI Score 1-5 | 60 month | 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 |
| FDI 6 Marginal Adaption, FDI Score 1-5 | 60 month | 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 |
| FDI 10 Patient's View, FDI Scire 1-5 | 60 month | 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 |
| FDI 1 Surface Luster, FDI Score 1-5 | 60 months | assessed on patient teeth (comparing surface of filling with enamel) following the FDI criteria on a scale from 1 very good to 5 unacceptable |
| FDI 12 Recurrence of Caries (CAR), Erosion, Abfraction, FDI Scores 1-5 | 60 month | 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 |
| FDI 13 Tooth Integrity, FDI Scores 1-5 | 60 month | 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 |
| FDI 11 Postoperative Hypersensitivity and Tooth Vitality, FDI Scores 1-5 | 60 month | 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 |
| FDI 2 Surface Staining, FDI Score 1-5 | 60 month | assessed on patient teeth by checking surface staining of restoration following the FDI criteria on a scale from 1 very good to 5 unacceptable |
| FDI 3 Translucency, FDI Score 1-5 | 60 month | 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 |
Countries
Liechtenstein
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 50 |
| 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. | 75 |
| Total | 125 |
Baseline characteristics
| Characteristic | F-Composite 2 System |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 50 Participants |
| Region of Enrollment Liechtenstein | 75 Teeth |
| Sex: Female, Male Female | 18 Participants |
| Sex: Female, Male Male | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 50 |
| other Total, other adverse events | 4 / 50 |
| serious Total, serious adverse events | 0 / 50 |
Outcome results
Primary
Percentage of Restored Teeth With Postoperative Sensitivity
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.
Time frame: 1 month
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| F-Composite 2 System | Percentage of Restored Teeth With Postoperative Sensitivity | 7 percentage restored hypersensitive teeth |
Secondary
Number of Restored Teeth With Loss of Vitality
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| F-Composite 2 System | Number of Restored Teeth With Loss of Vitality | 0 teeth |
Secondary
Replacement of Filling
maximum of 3 fillings which have to be replaced due to a lack of quality after 2 years
Time frame: 2 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| F-Composite 2 System | Replacement of Filling | 0 replaced fillings due to quality |
Other Pre-specified
FDI 10 Patient's View, FDI Scire 1-5
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
Time frame: 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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| F-Composite 2 System | FDI 10 Patient's View, FDI Scire 1-5 | FDI 10 Patient's View, FDI Score 1 | 60 Teeth |
| F-Composite 2 System | FDI 10 Patient's View, FDI Scire 1-5 | FDI 10 Patient's View, FDI Score 2-5 | 0 Teeth |
Other Pre-specified
FDI 11 Postoperative Hypersensitivity and Tooth Vitality, FDI Scores 1-5
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
Time frame: 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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| F-Composite 2 System | FDI 11 Postoperative Hypersensitivity and Tooth Vitality, FDI Scores 1-5 | FDI 11 Postoperative hypersensitivity and tooth vitality, FDI Score 1 | 60 Teeth |
| F-Composite 2 System | 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
FDI 12 Recurrence of Caries (CAR), Erosion, Abfraction, FDI Scores 1-5
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
Time frame: 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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| F-Composite 2 System | 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 |
| F-Composite 2 System | 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 |
| F-Composite 2 System | 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
FDI 13 Tooth Integrity, FDI Scores 1-5
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
Time frame: 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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| F-Composite 2 System | FDI 13 Tooth Integrity, FDI Scores 1-5 | FDI 13 Tooth integrity, FDI Score 1 | 58 Teeth |
| F-Composite 2 System | FDI 13 Tooth Integrity, FDI Scores 1-5 | FDI 13 Tooth integrity, FDI Score 2-3 | 0 Teeth |
| F-Composite 2 System | FDI 13 Tooth Integrity, FDI Scores 1-5 | FDI 13 Tooth integrity, FDI Score 4 | 1 Teeth |
| F-Composite 2 System | FDI 13 Tooth Integrity, FDI Scores 1-5 | FDI 13 Tooth integrity, FDI Score 5 | 1 Teeth |
Other Pre-specified
FDI 1 Surface Luster, FDI Score 1-5
assessed on patient teeth (comparing surface of filling with enamel) following the FDI criteria on a scale from 1 very good to 5 unacceptable
Time frame: 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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| F-Composite 2 System | FDI 1 Surface Luster, FDI Score 1-5 | FDI 1 Surface Luster, FDI Score 1 | 6 Teeth |
| F-Composite 2 System | FDI 1 Surface Luster, FDI Score 1-5 | FDI 1 Surface Luster, FDI Score 2 | 45 Teeth |
| F-Composite 2 System | FDI 1 Surface Luster, FDI Score 1-5 | FDI 1 Surface Luster, FDI Score 3 | 9 Teeth |
| F-Composite 2 System | FDI 1 Surface Luster, FDI Score 1-5 | FDI 1 Surface Luster, FDI Score 4-5 | 0 Teeth |
Other Pre-specified
FDI 2 Surface Staining, FDI Score 1-5
assessed on patient teeth by checking surface staining of restoration following the FDI criteria on a scale from 1 very good to 5 unacceptable
Time frame: 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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| F-Composite 2 System | FDI 2 Surface Staining, FDI Score 1-5 | FDI 2 Surface Staining, FDI Score 1 | 42 teeth |
| F-Composite 2 System | FDI 2 Surface Staining, FDI Score 1-5 | FDI 2 Surface Staining, FDI Score 2 | 17 teeth |
| F-Composite 2 System | FDI 2 Surface Staining, FDI Score 1-5 | FDI 2 Surface Staining, FDI Score 3 | 1 teeth |
| F-Composite 2 System | FDI 2 Surface Staining, FDI Score 1-5 | FDI 2 Surface Staining, FDI Score 4-5 | 0 teeth |
Other Pre-specified
FDI 3 Translucency, FDI Score 1-5
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
Time frame: 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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| F-Composite 2 System | FDI 3 Translucency, FDI Score 1-5 | FDI 3 Translucency, FDI Score 1 | 43 Teeth |
| F-Composite 2 System | FDI 3 Translucency, FDI Score 1-5 | FDI 3 Translucency, FDI Score 2 | 17 Teeth |
| F-Composite 2 System | FDI 3 Translucency, FDI Score 1-5 | FDI 3 Translucency, FDI Score 3-5 | 0 Teeth |
Other Pre-specified
FDI 5 Retention/Fracture of Restorations, FDI Score 1-5
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
Time frame: 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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| F-Composite 2 System | FDI 5 Retention/Fracture of Restorations, FDI Score 1-5 | FDI 5 Fracture of material and retention, FDI Score 1 | 51 Teeth |
| F-Composite 2 System | FDI 5 Retention/Fracture of Restorations, FDI Score 1-5 | FDI 5 Fracture of material and retention, FDI Score 2 | 4 Teeth |
| F-Composite 2 System | FDI 5 Retention/Fracture of Restorations, FDI Score 1-5 | FDI 5 Fracture of material and retention, FDI Score 3 | 5 Teeth |
| F-Composite 2 System | 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
FDI 6 Marginal Adaption, FDI Score 1-5
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
Time frame: 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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| F-Composite 2 System | FDI 6 Marginal Adaption, FDI Score 1-5 | FDI 6 Marginal Gap, FDI Score 1 | 49 Teeth |
| F-Composite 2 System | FDI 6 Marginal Adaption, FDI Score 1-5 | FDI 6 Marginal Gap, FDI Score 2 | 9 Teeth |
| F-Composite 2 System | FDI 6 Marginal Adaption, FDI Score 1-5 | FDI 6 Marginal Gap, FDI Score 3 | 2 Teeth |
| F-Composite 2 System | FDI 6 Marginal Adaption, FDI Score 1-5 | FDI 6 Marginal Gap, FDI Score 4-5 | 0 Teeth |