K08.1 K08.2
Conditions
Interventions
Group 1: Test group A: immediate loading/restoration of the mini-implants
Group 2: Control group B: delayed loading of the mini-implants
Sponsors
3M Deutschland GmbH, 3M ESPE Dental Products
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • Patients with a partial removable dental prosthesis in at least one jaw that show an unfavorable distribution and number of remaining abutment teeth At least one quadrant of the study jaw is either edentulous, shows exclusively anterior teeth, shows one posterior tooth but no caninus; (anterior teeth may be present), or shows two posterior teeth but no caninus and no anterior tooth. • The abutment teeth need to have sound periodontal conditions (pocket dephts = 4 mm, no bleeding on probing, attachment loss < two third of the root length, mobility grade = 2). • Vital or endodontically treated abutment teeth with a sealed root filling to the apical region without apical periodontitis. • No contraindication for implantation and sufficient bone in the study jaw to place an mini- implants without augmentation procedures • Written informed consent
Exclusion criteria
Exclusion criteria: • Contraindication for implantation without augmentation caused by local bone deficits • Patients who are satisfied with their PRDP • Patients who refuse randomizations to one of the study groups • poor general health, e.g. Class III-IV according to the classification der American Society of Anaesthesiology (ASA), severe renal/or liver disease, history of a radiotherapy in the head region, chemotherapy at the time of surgical procedure, non-compensated diabetes mellitus, HIV, • intravenous bisphosphonate therapy • mental disorders • drug abuse • active periodontal disease • poor oral hygiene (API > 25%)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoints: • Periodontal conditions of the abutment teeth (mobility grades 0-3, Periotest values, probing depths) • Oral health related quality of life (measure: short German version of the oral health impact profile (OHIP-G14)2 • Patient`s satisfaction with the PRDP (Likert scale: totally satisfied - not at all satisfied)3 • Food frequency questionnaire 4 will be completed by the patients to evaluate the nutrition of the patients • Chewing efficiency will be quantified with color-mixing ability test using a two colored chewing gum (optoelectronical.evaluation of the ratio of unmixed azure color pixels to the total pixel number in a fixed size template)5, 6 • subjective (Likert scale: totally satisfied to not at all satisfied) 3 and objective denture retention (rating as good: difficult to dislodge, fair: some resistance to dislodgment, or poor: minimal or no resistance to dislodgment); Pre-treatment and follow-up examinations (for all outcomes): prior to implant placement, 14 days, 4 months, 1 year, 2 years and 3 years after implant placement ; | — |
Secondary
| Measure | Time frame |
|---|---|
| • Tooth loss • Implant loss • Implant success rate according to the modified criteria of Albrektsson et al. (1986). • Periodontal and peri-implant conditions (probing depths, bleeding on probing, modified plaque index, modified sulcus bleeding index, tooth mobility and implant mobility measured by Periotest and Osstell) • Caries/endodontic complications at abutment teeth • Prosthetic complications: implant- or tooth fracture, prosthesis fracture, loss of retention, housing detachments, loss of o-rings • Prothetic aftercare: relining, exchange o-rings; Follow-up examinatons after implant placement (for all outcomes): after 14 days, 4 months, 1 year, 2 years and 3 years ; radiographs: on the date of implant placement, 1 year and 3 years after implant placement | — |
Countries
Germany
Contacts
Public ContactTorsten Mundt
Universitätsklinikum GreifswaldPoliklinik für Zahnärztliche Prothetik
Outcome results
None listed