Peri-implantitis
Conditions
Interventions
Each patient will receive two types of implants with different surface roughness from the Southern Implants system. The implants are to replace single partially edentulous spaces in the mandibular pre
Sponsors
ACTA Dental Research B.V., Gustav Mahlerlaan 3004, 1081 LA, Amsterdam, The Netherlands
Eligibility
Inclusion criteria
Inclusion criteria: - Age at least 18 years - Provision of written informed consent - Agree to return for follow-up visits after 1, 2 and 3 years - Periodontally compromised patients having a history of proximal attachment loss of > 5mm in > 30% of teeth present and enrolled in a supportive periodontal therapy (SPT) program after active periodontal treatment - Requirement of two single-unit fixed partial dentures (FPDs supported by two implants in mandibular premolar and/or molar region - Adjacent natural tooth/teeth - In antagonistic jaw natural teeth, partial prosthesis, or implant supported (partial) prosthesis in contact with planned FPD - History of edentulism in planned implant area > 4 months - At planned implant area, a minimum of 12 mm bone in vertical dimension and minimum of 6 mm in horizontal dimension available - Acquiring a primary stable implant situation assumed by investigator
Exclusion criteria
Exclusion criteria: - History of local radiotherapy to the head and neck region - History of chemotherapy 10 cigarettes a day - Uncontrolled diabetes mellitus - Known or suspected current malignancy - Pregnancy at time of inclusion - Alcohol or drug abuse - Any systemic or local disease that would compromise postoperative healing and/or osseointegration - Need for systemic bisphosphonates, corticosteroids or any other medication that would compromise postoperative healing and/or osseointegration - History of systemic bisphosphonates - Presence of active clinical periodontal disease expressed by probing pocket depths > 5 mm and bleeding on probing - History of necrotic or rapid progressive periodontitis - Untreated caries and/or endodontic disease - Previous implant loss - Previous bone augmentation in planned implant area - Severe grinding/clenching habits - Incapability of performing oral hygiene as a result of physical or mental disorders - During any period of the study, if any mandatory procedures and measurements are missing by the investigator, the dataset of that subject will be removed from the final results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure is the radiographical change in implant mean marginal bone level (MBL) on the mesial and the distal site 36 months after delivery of the fixed partial dentures (FPDs). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes are implant survival, implant stability, marginal peri-implant soft tissue conditions (amount of plaque, bleeding on probing and pocket probing depths) and peri-implant microbiological composition. | — |
Contacts
Public ContactAnton Dank
Vrije Universiteit Amsterdam
Outcome results
None listed