Clinical Evaluation of a New Flowable and a New Sculptable Universal Bulk-fill Composite for Direct Restorative Treatment

Ivoclar Vivadent

Status

Active, not recruiting

Conditions

Insufficient Dental Filling or Primary Caries (Class I or II Cavities in Premolars or Molars)

Treatments

Device: TM Fill in combination with TM Flow

Study type

Interventional

Funder types

Industry

Identifiers

NCT06369779

OTCS 36406866

Details and patient eligibility

About

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.

Enrollment

65 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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