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Clinical evaluation of the performance of a composite material used in the warming technique

Clinical evaluation of the performance of a composite material used in the warming technique - Composite Warming

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
DRKS
Registry ID
DRKS00020546
Enrollment
50
Registered
2020-02-14
Start date
2019-11-26
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

K02.9

Interventions

Group 1: Placement of Class II restoration using cold (room temperature) composite material Group 2: Placement of Class II restoration using the same, but pre-warmed composite material

Sponsors

3M Oral Care
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Subject is between 18 and 75 years of age 2. Subject is in good general health (ASA 1 or 2) 3. Subject does not have known allergies against any study substances 4. Subject has at least two teeth in need of a Class II restoration 5. Existing restorations that only require repair (instead of replacement) will be excluded 6. Both study teeth must have a good prognosis for the next 3 years (no increased tooth mobility, periodontal probing depth is =5 mm, no signs of pulpitis, no pulp exposure during treatment, study teeth are vital, level of oral hygiene is sufficient) 7. Subject does not suffer from bruxism (i.e. wears a mouth guard or should wear a mouth guard) or from traumatic malocclusion 8. Each study restoration has at least one proximal contact and is stress bearing with at least one occlusal antagonistic contact 9. In case study restorations are in antagonistic contact with each other: each study restoration has at least one antagonistic occlusal contact to natural tooth substance 10. Subject does not have excessive dietary or environmental exposure to acids or suffer from eating disorders 11. Subject is not pregnant or breast feeding 12. Subject volunteers to participate in the study and is available for recalls during the 3 years study duration 13. Subject does not participate in any other study

Exclusion criteria

Exclusion criteria: See inclusion criteria

Design outcomes

Primary

MeasureTime frame
Restoration survival based on FDI criteria during 3 years follow-up

Secondary

MeasureTime frame
Restoration quality based on FDI criteria during 3 years follow-up

Countries

Iceland

Contacts

Public ContactVilhelm Grétar Ólafsson

Assistant Professor in Operative Dentistry and CariologySchool of Health SciencesFaculty of OdontologyUniversity of Iceland

vgo@hi.is+354 525 4870

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026