K12.3
Conditions
Interventions
Group 1: Dental implant with healing abutment with microgrooved surface
After a 12 weeks healing period, oral hygiene practices in the implant area will be refrained for 3 weeks (exposition phase). Th
Sponsors
Poliklinik für Zahnärztliche Chirurgie und Aufnahme, Universitätsklinikum Düsseldorf
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Subjects must have voluntarily signed the informed consent form before any study related action 2. Males and females between 18 and 65 years of age 3. Non-smokers 4. Edentulous or partially edentulous in posterior maxilla or mandible (#4-#7 FDI) with 1 implant planned (maximum 2 non adjacent implants). 5. Full mouth plaque (FMPS) must be = 15% at time of surgery 6. Full mouth bleeding score (FMBS) must be = 15% at time of surgery 7. Adequate bone quality and quantity at the implant site to permit the insertion of a titanium implants of >4.0 mm diameter 8. Vertical Soft tissue Dimenson =2 mm around the implant position 9. Width of keratinised tissue = 2mm around experimental implants
Exclusion criteria
Exclusion criteria: Pre-surgical exclusion criteria 1. Systemic disease that would interfere with dental implant therapy (e.g. uncontrolled diabetes) 2. Any contraindications for oral surgical procedures 3. Mucosal diseases (e.g. erosive lichen planus) 4. History of local irradiation therapy 5. Current untreated periodontitis or gingivitis 6. Any untreated endodontic lesion 7. PPD of = 4 mm on one of the teeth immediately adjacent to the dental implant site 8. Keratinized gingiva < 2 mm or thin biotype 9. Severe bruxing or clenching habits 10. Patients with inadequate oral hygiene or unmotivated for adequate home care 11. Patients who smoke or chew tobacco 12. Subjects who have undergone administration of any investigational device within 30 days of enrolment in the study 13. Conditions or circumstances, in the opinion of the investigator, which would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance or unreliability 14. Use of systemic antibiotics in the past 3 months 15. Use of systemic antibiotics for endocarditis prophylaxis 16. Physical or mental handicaps that would interfere with the ability to perform adequate oral hygiene 17. Pregnant or breastfeeding women Secondary Exclusion Criteria at Implant Surgery 1. Lack of primary stability of the implant 2. Simultaneous augmentation procedures Secondary Exclusion Criteria at end of healing phase 1. Full mouth plaque score must be = 15% at the end of healing phase 2. Full mouth bleeding score must be = 15% at the end of healing phase 3. Mobility or infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical changes during the exposition and resolution period with regard to the following parameter at days 0, 7, 14 and 21 (exposition period), as well as at 2, 4, and 16 weeks (resolution period): Bleeding on Probing (BOP) | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical and immunological changes during the exposition and resolution period with regard to the following parameters at days 0, 7, 14 and 21 (exposition period), as well as at 2, 4, and 16 weeks (resolution period): Clinical evaluation (measured at six aspects): Plaque Index (PI), Modified gingival index (MGI), Probing Pocket depths (PPD), Mucosal Recession (MR), Clinical Attachment Level (CAL), Width of the keratinized mucosa (KM) Immunological evaluation: Matrix metalloproteinase 8 (sulcus fluid) (MMP-8) Evaluation of any complications and adverse events (i.e. Safety analysis). | — |
Countries
Germany
Contacts
Public ContactFrank Schwarz
Poliklinik für Zahnärztliche Chirurgie und Aufnahme, Universitätsklinikum Düsseldorf
Outcome results
None listed