Insufficient Dental Filling or Primary Caries (Class I or II Cavities in Premolars or Molars)
Conditions
Brief summary
The overall objective of this clinical investigation is to evaluate the clinical safety and performance of the new flowable composite TM Flow and the new sculptable composite TM Fill for restoration of class I and class II cavities. The fillings are assessed according to selected FDI (Fédération Dentaire Internationale) criteria at baseline (7-10 days after placement of filling) and after 1, 6, 12, 24, 36 and 60 months.
Interventions
DEVICETM 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).
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
* Informed Consent signed by the subject * Age: 18-65 years * Indication Class I or II direct restorations in premolars or molars (Replacement of insufficient fillings due to secondary caries, fractures, insufficient marginal adaptation, loss of filling or primary caries) * Cavity width must be at least half of the cusp tip distance * Vital teeth, regular sensitivity * Sufficient language skills * No active periodontits * Preoperative VAS (visual analogue scale) values \< 3 regarding tooth sensitivity and biting
Exclusion criteria
* Sufficient isolation of the cavity not possible * Not completed hygiene phase or poor oral hygiene * Missing antagonist, non-occlusion * Missing tooth adjacent to the tooth to be treated * Restorations replacing more than 1 cusp * Caries profunda or very deep cavity * Patients with a proven allergy to ingredients of the used materials (methacrylates) or local anesthetics (Articain, sulfite) * Patients with severe systemic diseases * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Hypersensitivity | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of Functional (e.g. Fracture of the Material and Retention), Biological (e.g. Caries at Restoration Margins) and Aesthetic (e.g. Color Match) Properties of the Restorations | 5 years | will be assessed according to FDI criteria (grade 1-5) |
Countries
Liechtenstein
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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). | 65 |
| Total | 65 |
Baseline characteristics
| Characteristic | Test group (TM Fill in combination with TM Flow) | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 65 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 27 Participants | — |
| Sex: Female, Male Male | 38 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 65 |
| other Total, other adverse events | 0 / 65 |
| serious Total, serious adverse events | 0 / 65 |
Outcome results
Primary
Postoperative Hypersensitivity
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
Time frame: 1 month
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Test group (TM Fill in combination with TM Flow) | Postoperative Hypersensitivity | FDI Score 1 | 63 Restorations |
| Test group (TM Fill in combination with TM Flow) | Postoperative Hypersensitivity | FDI Score 2 | 0 Restorations |
| Test group (TM Fill in combination with TM Flow) | Postoperative Hypersensitivity | FDI Score 3 | 1 Restorations |
| Test group (TM Fill in combination with TM Flow) | Postoperative Hypersensitivity | FDI Score 4-5 | 0 Restorations |
Secondary
Evaluation of Functional (e.g. Fracture of the Material and Retention), Biological (e.g. Caries at Restoration Margins) and Aesthetic (e.g. Color Match) Properties of the Restorations
will be assessed according to FDI criteria (grade 1-5)
Time frame: 5 years