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

• Conditions: Z96.5; Presence of tooth-root and mandibular implants

• Registration Number: DRKS00033851
• Lead Sponsor: ZahnMedizinCenter-Anhalt

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-22
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 24

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

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

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.