Missing (pre-) molars in the lateral part of the maxilla or mandible and a compromised oral function as a consequence.
Conditions
Interventions
mplant placement
Implant treatment consists of the placement of a single implant (Conelog Progressive-Line, Promote Plus 4.3mm with a minimal length of 11mm, Camlog Biotechnologies GmbH, Basel, Switze
Sponsors
Oral Recontruction Foundation
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion criteria - Patients older the 18 years old, in good physical, mental and periodontal health; - A diastema in the premolar of molar area of the maxilla or mandible between 10-16 mm wide (2 premolars); - Ample bone volume and height to place a single implant of at least 4.1 mm in diameter and 8 mm in length at the posterior end of the diastema; - Natural teeth as antagonist.
Exclusion criteria
Exclusion criteria: Exclusion criteria - Radiotherapy involving the implant area; - Current smoking habit that exceeds 5 cigarettes a day; - Evidence of bruxism or other parafunctional habits.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome parameter The primary outcome variable is the mean marginal bone loss, for which the Marginal Bone Levels (MBL) between placement of the restoration (T0) and after 3 years (T3) are determined from standardized, long cone intraoral radiographs, by measuring from the edge of the implant to the bone-to-implant contact, both mesially and distally. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome parameters - Survival of the implant (Isur) defined as the presence of the implant at any moment of observation is noted and presented according to Kaplan Meier; - Survival (Rsur) and success (Rsuc) of the restoration defined as the presence of the restoration at any moment of observation (Rsur), without any complications or interventions (Rsuc). - Patient reported outcome: This is determined by means of a validated questionnaire that measures people's perceptions of their quality of life related to their oral health (OHIP-NL 49)(7) and a Visual Analogue Scale (VAS) on general satisfaction with the function of their cantilever bridge (range 0-100); - Clinical parameters indicative for peri-implant soft tissue health include Probing Pocket Depth (PPD), recession (REC), Gingival Index (GI), Plaque Index (PI) and Bleeding On Probing (BOP) is assessed at 4 sites per implant (8,9); - All subjects are continuously monitored during the course of the trial for adverse events. These will be recorded, as well as detailed post-insertion maintenance and restorative complications | — |
Contacts
Public ContactCharlotte Jensen-Louwerse
University Medical Center Groningen
Outcome results
None listed