Prospective Randomized Controlled Double-Blinded Clinical Study of Additively Manufactured Dental Single Crowns in the Posterior Region

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00035714

Enrollment

Registered

2025-03-06

Start date

2025-04-15

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: Additively manufactured single crowns using TSLA in the posterior region Group 2: Subtractively manufactured single crowns in the posterior region

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Age 18 years or older Need for dental single crown(s) (SC) General health condition of the patient allows for dental treatment Written consent has been obtained

Exclusion criteria

Exclusion criteria: Patients who do not meet the above criteria Periodontitis (Periodontal Screening Index > 3 in the relevant sextant) Insufficient oral hygiene Patients for whom participation in the study would pose an undue burden due to their age, degree of disability, or general health condition.

Design outcomes

Primary

Measure	Time frame
The primary objective of the project is to investigate the survival rate and longevity of 3D-printed single-tooth restorations compared to subtractively manufactured single-tooth restorations in the posterior region over a 5-year period.	—

Secondary

Measure	Time frame
The secondary objective of the project is to determine the success rate of 3D-printed single-tooth restorations compared to subtractively manufactured single-tooth restorations with regard to color matching, potential marginal discoloration, presence of secondary caries, anatomical shape, surface texture, plaque accumulation, gingival health, and patient satisfaction/quality of life using USPHS-Criteria (United States Public Health Service) and OHIP-G14 questionnaire after 1, 3 and 5 years.	—

Measure

Time frame

The secondary objective of the project is to determine the success rate of 3D-printed single-tooth restorations compared to subtractively manufactured single-tooth restorations with regard to color matching, potential marginal discoloration, presence of secondary caries, anatomical shape, surface texture, plaque accumulation, gingival health, and patient satisfaction/quality of life using USPHS-Criteria (United States Public Health Service) and OHIP-G14 questionnaire after 1, 3 and 5 years.

—

Countries

Germany

Contacts

Public ContactBenedikt Spies

Universitätsklinikum Freiburg

benedikt.spies@uniklinik-freiburg.de+49 761 270-49060

Outcome results

None listed

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