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Clinical and radiographic effects of TiUltra after prosthetic restoration - a practice-based observational study

Clinical and radiographic effects of TiUltra after prosthetic restoration - a practice-based observational study - non Xeal_TiUltra

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00033851
Enrollment
24
Registered
2024-03-22
Start date
2024-04-01
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

Z96.5

Interventions

Group 1: In suitable patients (e.g: willingness to participate in the observational study over a period of three years), bridges (configuration: implant_end-to-implant_end bridges, e.g.: Implant-bridg
Nobel Parallel Conical Connection, TiUltra surface
Multi-unit abutments, without Xeal surface) should be placed. Patients with one or more at least three-unit, at least single-span bridges (configuration: implant-bridge pontic implant) in the maxilla

Sponsors

ZahnMedizinCenter-Anhalt
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Mentally healthy adults, i.e. patients capable of giving consent - Good general health (ASA = 2) a. Diabetes mellitus should be well controlled (HbA1c < 7) b. Smoking = 20 cigarettes / day c. No alcohol or drug abuse - No pathology of the bone metabolism - Patients with periodontitis should be successfully treated, i.e. no remaining periodontal infection as far as possible - Good oral hygiene and compliance, i.e. plaque level (full-mouth plaque score, FMPS) < 25% and bleeding level after probing (full-mouth bleeding on probing score, FMBS) < 25% - A 3D radiological bone volume (possibly after augmentative procedures such as sinus lift) must be available for insertion of the planned implants. - Patient and anatomical conditions must correspond to the instructions for use of the implants to be used (Nobel Parallel Conical Connection, TiUltra surface). - Edentulous areas must be suitable for the planned implant-supported restoration. - Sufficiently keratinised peri-implant mucosa. - Tooth removal should generally have taken place three months previously. - Existing opposing dentition - Patients must be prepared to adhere to a prevention concept (supportive therapy, UT). This is a routine protocol. - Written informed consent for participation in this study

Exclusion criteria

Exclusion criteria: - Minors - Pregnant and breastfeeding patients - Taking antiresorptives - Patients with a known titanium allergy - Patients with CMD symptoms

Design outcomes

Primary

MeasureTime frame
The primary aim is to systematically record and evaluate the stability of the peri-implant bone level one, two and three years after prosthetic restoration.

Secondary

MeasureTime frame
Secondary objectives are the systematic recording and evaluation of the implant survival rate, implant survival rate, biological complications (i.e. peri-implant mucositis, peri-implantitis), technical complications (i.e. implant fracture, abutment screw fracture, abutment screw loosening, fracture of the prosthetic restoration, loosening of the prosthetic restoration) and survival rate of the prosthetic restoration one, two and three years after prosthetic restoration.

Countries

Germany

Contacts

Public ContactChristian Halle

ZahnMedizinCenter-Anhalt

ZA.ChristianHalle@t-online.de+49 (0) 3493-81076

Outcome results

None listed

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