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

NCT06369779 | Active Not Recruiting Results

• 1 other identifier: OTCS 36406866
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

  1 month

Secondary Outcomes (1)

• 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

Study Arms (1)

Test group (TM Fill in combination with TM Flow)

EXPERIMENTAL

TM Fill an TM Flow are used for restoration of class I and class II cavities

Device: TM Fill in combination with TM Flow

Interventions

TM Fill in combination with TM Flow DEVICE

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).

Test group (TM Fill in combination with TM Flow)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ivoclar Vivadent AG: lead

Study Sites (1)

Ivoclar Vivadent AG

Schaan, Liechtenstein, 9494, Liechtenstein

Location

Results Point of Contact

• Title: Team Leader Study Management
• Organization: Ivoclar Vivadent AG

patrizia.elkuch-hoch@ivoclar.com

+4232353780

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2024
• First Posted: April 17, 2024
• Study Start: May 13, 2024
• Primary Completion: August 12, 2024
• Study Completion (Estimated): December 1, 2030
• Last Updated: October 23, 2025
• Results First Posted: May 31, 2025

Record last verified: 2025-07

Locations

LI (1)