Complications: Inflammatory Reactions, Mechanical Complications Clinical Trial
Official title:
Implant Supported Single Crowns With Different Retention Modes - Effects on Peri-implant Tissue: A Prospective Randomized Controlled Clinical Trial
This study aims to examine the inflammatory response mediated by MMP-8 (Matrix metalloproteinase-8 ) level in peri-implant sulcus fluid adjacent to screw-retained, cemented or using the Acuris-system fixed single implant crowns as well as changing of the marginal bone level within the first year after implant restoration. Furthermore periodontal parameters, patient satisfaction and possible occurring biological or technical complications will be evaluated.
| Status | Recruiting |
| Enrollment | 39 |
| Est. completion date | November 2024 |
| Est. primary completion date | November 2024 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 99 Years |
| Eligibility | Inclusion Criteria: - capability of giving an informed consent - good health as defined by the subjects medical history (no contraindications as described in the exclusion criteria below) - age 18 to 99 years - Good periodontal status: BOP < 20%, PI < 30%, no PD > 4mm - No heavy smokers (< 10 cigarettes/day) - at least 1 missing tooth in the premolar and molar region (with at least a mesial neighboring tooth/implant showing adequate hard- and soft tissue situation without the need of crestal hard- or soft tissue augmentation) either in the maxilla or in the mandible requiring implant therapy for reconstruction, requiring sinus floor augmentation or not. Exclusion Criteria - Insufficient bone volume for implant placement requiring GBR (guided bone regeneration) procedure in crestal area. - Heavy Smokers (>10 cigarettes/day) - Medication with a contraindication for implant therapy (especially antiresorptive therapy, ongoing or recently completed local radiotherapy, systematic diseases, ongoing immunosuppressive therapy, functional disorders like Bruxism). - Skeletal immaturity. - Any active malignancy or ongoing treatment for malignancy. - An active infection (e.g. caries, gingivitis, periodontitis) at or in the neighboring area of the operative site. - Pregnancy - unable or unwilling to return for follow-up visits for a period of at least 16 months |
| Country | Name | City | State |
|---|---|---|---|
| Austria | Medical University of Graz, Department of Dental Medicine and Oral Health, Division of Oral Surgery and Orthodontics | Graz |
| Lead Sponsor | Collaborator |
|---|---|
| Medical University of Graz |
Austria,
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* Note: There are 15 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change of marginal bone level | assessed by single tooth x-ray; in mm | at baseline, 4 months after implant placement and 3, 6 and 12 months after restoration | |
| Primary | Change of matrix metalloproteinase 8 level | biomarker for Inflammation of peri-implant disease; in ng/ml | 4 months after implant placement, 3, 6 and 12 months after integration of the implant crown | |
| Secondary | Change of probing depth (PD) | using a periodontal probe; in mm | at baseline, 4, 7, 10, 16 months after implantation | |
| Secondary | Number of occurrences of chipping | visual check | measured after integration of implant crown 3, 6 and 12 months after restoration | |
| Secondary | soft tissue maintenance | Papilla Index (Jemt T, 1997), the index ranges from 0 to 4, while 2 and 3 indicate physiological outcome | measured 4 months after implant placement and 3, 6 and 12 months after restoration | |
| Secondary | technician satisfaction | evaluated using an individual questionnaire | measured 12 months after restoration | |
| Secondary | dentist satisfaction | evaluated using an individual questionnaire | measured 12 months after restoration | |
| Secondary | patient satisfaction | evaluated using OHIP-G 14 questionnaire. The following dimensions are captured by the OHIP-G 14: functional Limitation (e.g., "pronouncing any words because of problems with your teeth, mouth, dentures, or jaw?") and physical Pain (e.g., "Have you had painful aching in your mouth"). 14 questions are raised, which are answered using a rating scale from 0 (never) to 4 (very often). | measured at baseline, 3 and 12 months after restoration | |
| Secondary | Plaque Index (PI) | in percent | at baseline, 4, 7, 10 and 16 months after implantation | |
| Secondary | Bleeding on Probing (BOP) | in percent | at baseline, 4, 7, 10 and 16 months after implantation | |
| Secondary | Patient satisfaction concerning the implant crown | evaluated using an individual questionnaire | measured 12 months after restoration | |
| Secondary | Number of occurrences of fractures | visual check | measured after integration of implant crown 3, 6 and 12 months after restoration | |
| Secondary | Number of occurrences of screw loosening | visual check | measured after integration of implant crown 3, 6 and 12 months after restoration | |
| Secondary | Number of occurrences of crown loosening | visual check | measured after integration of implant crown 3, 6 and 12 months after restoration |