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Randomized clinical trial on the performance of direct and indirect composite restorations in patients with severe tooth wear

Randomized clinical trial on the performance of direct and indirect composite restorations in patients with severe tooth wear - Treatment of severe tooth wear

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON34996
Enrollment
150
Registered
2010-08-17
Start date
2011-02-14
Completion date
Unknown
Last updated
2024-07-22

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

Conditions

Tandheelkundige aandoeningen Dental tooth wear loss of vertical dimension of occlusion

Interventions

Patients will be randomized (block-randomization) divided over two treatment protocols (indirect and direct) and over the use of a temporary appliance (with or without).

Sponsors

Universitair Medisch Centrum Sint Radboud
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Generalized tooth wear - Clear demand for treatment - Necessary increase of vertical dimension of occlusion >=3 mm - Continious dental arches with a minimum of three posterior teeth (premolars and molars) per quadrant - A maximum of one edentulous space in need for treatment - This space has a maximum span of one tooth-width

Exclusion criteria

Exclusion criteria: - ASA 4 - Necessary increase of vertical dimension of occlusion

Design outcomes

Primary

MeasureTime frame
- The percentage of failed restorations - Number of interventions needed after bite raise to make patients accept bite-raise within 6 months

Secondary

MeasureTime frame
Secondary outcome parameters regarding the necessity of the appliance on the short-term (until six months after treatment): - Time to clinical acceptance of bite raise - Restoration of chewing function - Adjustment to increased occlusal height - Patient satisfaction, pain and comfort - 'Quality of Life' related to Oral Health Secondary outcome parameters for the comparison between the two restoration techniques on the long-term, after 1 - 5 years: - Restoration performance - Patient satisfaction - Association between clinical performance and wear etiology - Maintenance costs - Tooth and restoration material loss - 'Quality of Life' related to Oral Health

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)