---
title: Clinical Evaluation of a New Flowable and a New Sculptable Universal Bulk-fill Composite for Direct Restorative Treatment
nct_id: NCT06369779
overall_status: ACTIVE_NOT_RECRUITING
phase: NA
sponsor: Ivoclar Vivadent AG
study_type: INTERVENTIONAL
primary_condition: Insufficient Dental Filling or Primary Caries (Class I or II Cavities in Premolars or Molars)
countries: Liechtenstein
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06369779.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06369779"
ct_last_update_post_date: 2025-10-23
last_seen_at: "2026-05-12T06:13:05.285Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Clinical Evaluation of a New Flowable and a New Sculptable Universal Bulk-fill Composite for Direct Restorative Treatment

**Official Title:** Clinical Evaluation of Class I and II Cavities Restored With the Combination of a New Flowable and a New Sculptable Universal Bulk-fill Composite: A Prospective Single Arm Study

**NCT ID:** [NCT06369779](https://clinicaltrials.gov/study/NCT06369779)

## Key Facts

- **Status:** ACTIVE_NOT_RECRUITING
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 65
- **Lead Sponsor:** Ivoclar Vivadent AG
- **Conditions:** Insufficient Dental Filling or Primary Caries (Class I or II Cavities in Premolars or Molars)
- **Start Date:** 2024-05-13
- **Completion Date:** 2030-12
- **CT.gov Last Update:** 2025-10-23

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 65 Years
- **Sex:** ALL
- **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
```

## Arms

- **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

## 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).

## Primary Outcomes

- **Postoperative Hypersensitivity** _(time frame: 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 Outcomes

- **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** _(time frame: 5 years)_

## Locations (1)

- Ivoclar Vivadent AG, Schaan, Liechtenstein, Liechtenstein

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.ivoclar vivadent ag|schaan|liechtenstein|liechtenstein` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT06369779.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT06369779*  
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