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RCT based PREMs/PROMs and long-term clinical performance of three different types of implant single crowns immediately placed on dynamically navigated N1 implants

RCT based PREMs/PROMs and long-term clinical performance of three different types of implant single crowns immediately placed on dynamically navigated N1 implants

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00035961
Enrollment
180
Registered
2025-09-01
Start date
2025-09-15
Completion date
Unknown
Last updated
2025-10-06

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

Conditions

Tooth gap: Single crown replacement required in the posterior region

Interventions

Group 1: All ceramic screwed Procera crown. Group 2: All ceramic screwed Nobel Procera ASC crown. Group 3: All ceramic cemented Procera crown.

Sponsors

Goethe-Universität Frankfurt Zentrum der Zahn-, Mund- und Kieferheilkunde Abteilung für Postgraduale Ausbildung
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: General Inclusion criteria: - Age of study participants: 18-80 years at inclusion - Signed informed consent - Patient in good medical and psychological health with availability for follow-up. - Adequate oral hygiene And the following local Inclusion Criteria: - Patient with single-tooth implant indication: missing a single mandibular or maxillary tooth. And in need of implant-supported, single restoration. - Sufficient bone and keratinized soft tissue availability for implant placement without regenerative therapy: Presence of adequate of vertical and horizontal native bone in the recipient sites to allow implant placement without the need for bone regeneration techniques: healed sites with vertically and horizontally at least 1 mm of bone around the implant and thus no need for augmentation; minimum bone height: = 7 mm and minimum bone width: = 5.0 mm. It is also required to present sufficient keratinized gingival tissue (at least 2 mm) and to meet appropriate standards of oral hygiene (plaque and gingival indices <15%), since the study aims to evaluate healthy peri-implant mucosa, and no signs of peri-implant tissue disease are therefore allowable. - Presence of both adjacent teeth. - antagonistic jaw with antagonistic natural dentition or tooth/implant borne rehabilitation which can be used to create a stable occlusal fit with the new restoration.

Exclusion criteria

Exclusion criteria: Exclusion criteria: Any of the following is regarded as a criterion for exclusion from the study: 1. Unlikely to be able to comply with study procedures according to Investigators judgement. 2. Heavy smoking >10 cigarettes per day 3. Present alcohol or drug abuse 4. History of radiation therapy in head and neck region for Tumor therapy 5. History of chemotherapy within 5 years prior to surgery 6. Condition that would compromise post-operative tissue healing or osseointegration 7. High biphosphonate titer: Bisphosphonates or any other medication that would compromise post-operative healing or osseointegration. 8. Known pregnancy at time of inclusion 9. Current or former participation in a clinical study that may interfere with the present study 10. Involvement in the planning and conduct of the study 11. History of bone augmentation in the maxilla within 6 months prior to surgery 12. Uncontrolled pathologic processes in the oral cavity

Design outcomes

Primary

MeasureTime frame
- Recorded clinical and technical workflow times - Patient-Reported Outcome Measures (PROMs) - Patient-Reported Experience Measures (PREMs) - WES: Esthetic Score - FIPS: Functional Implant Prosthodontic Score - PES: Pink Esthetic Score:

Secondary

MeasureTime frame
Secondary endpoint: - Crestal bone behavior - Incidence of mucositis

Countries

Germany

Contacts

Public ContactPaul Weigl

Goethe-Universität Frankfurt Zentrum der Zahn-, Mund- und Kieferheilkunde Abteilung für Postgraduale Ausbildung

weigl@em.uni-frankfurt.de+49 69 6301 4731

Outcome results

None listed

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