Z96.5
Conditions
Interventions
Group 1: This is a monocentric, practice-based observational study in the dental practices of Dr Albarazi (Herrenstraße 1 in 3240 Mank and Gersthofer Straße 63 in 1180 Vienna, Austria) with an interve
ON1TM abutments, without the XealTM surface) will be placed. Patients with posterior maxillary or mandibular interocclusal or free-end gaps will be included. Randomisation and blinding are not planned
Sponsors
Dr. Mohammad Albarazi MSc Zahnordinationen
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Inclusion criteria - Mentally healthy adults, i.e. patients capable of giving informed 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. as far as possible no remaining periodontal infection. - 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 augmentation 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 (NobelParallelTM Conical Connection, TiUltraTM surface). - Edentulous areas must be suitable for the intended 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: Exclusion criteria - Minors - Pregnant and breastfeeding patients - Taking antiresorptives - Patients with a known titanium allergy - Patients with temporomandibular joint dysfunction (TMD, TMJD)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective is to determine peri-implant marginal bone level changes of functionally loaded implants at patient level (?PMKPatient) after an examination period of three years. Point in time: Patient treatment Before enrolment in the clinical trial - Pre-selection of patients - 3D X-ray images - Patient information - Written declaration of consent to participate - Clinical examination - Treatment planning - implant planning - Supportive therapy UT (if necessary) Inclusion in the observational study - Implantation - Digital X-ray - Transgingival healing Generally twice a year UT. + 8 weeks - Start of the prosthetic restoration in a digital workflow - Implant loss (early loss) + 1-2 week - Insertion of the prosthetic restoration - Digital X-ray image (RöBL) + 2 weeks - Checking the static and dynamic occlusion - Recording (photo) of the static (blue occlusion paper) and dynamic dynamic (red occlusion paper) occlusion + 3 months after insertion of the prosthetic restoration Clinical examination (implants only) - Implant loss (late loss) - Biological complications - Technical complications - Loss of the prosthetic restoration + 1, 2, 3 years after insertion of the prosthetic restoration Clinical examination (teeth and implants) - Implant loss (later loss) - Biological complications - Technical complications - Loss of the prosthetic restoration - Digital X-ray (X-ray years) The minimum total study duration for the individual patient is therefore approx. 3 years and 2 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| The most important secondary target parameter is the determination of the cumulative implant loss rate at patient level (KVPatient) after three years. Other secondary study parameters are the determination of peri-implant marginal bone level changes at implant level (?PMKImplant), the determination of the cumulative implant loss rate at implant level (KVImplant), cumulative rates of biological complications at implant and patient level (i. e. mucositis (KMRIimplant, KMRPatient), peri-implantitis (KPIimplant, KPRPatient)), cumulative technical complication rates (KTKRIimplant or prosthetic restoration, KTKRPatient) and cumulative loss rates of the prosthetic restoration (KVR prosthetic implant, KVR prosthetic patient), plaque index (PI), gingival index (on teeth GI, on implants mGI), width of keratinised mucosa on implants (BKG) and bleeding index (BI), which are recorded in all routine examinations over a period of three years. | — |
Countries
Austria
Contacts
Public ContactMohammad Albarazi
Dr. Mohammad Albarazi MSc Zahnordinationen
Outcome results
None listed