Evaluation of peri-implant mucositis at microgrooved and machined abutments: A two-center study
- Conditions
- K12.3Oral mucositis (ulcerative)
- Registration Number
- DRKS00009394
- Lead Sponsor
- Poliklinik für Zahnärztliche Chirurgie und Aufnahme, Universitätsklinikum Düsseldorf
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 28
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
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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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)<br><br>
- Secondary Outcome Measures
Name Time Method 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):<br><br>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)<br><br>Immunological evaluation: <br>Matrix metalloproteinase 8 (sulcus fluid) (MMP-8)<br><br>Evaluation of any complications and adverse events (i.e. Safety analysis).<br><br>