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| ID | Type | Description | Link |
|---|---|---|---|
| CIV-12-10-009101 | Other Identifier | EUDAMED |
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No patients could be recruited
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Immunologically evaluation of myeloperoxidase level as indicator for inflammatory reactions on modified surface abutments compared to machined surface abutments.
One study abutment per patient will be placed. After healing for 6 to 7 weeks, patients will be asked to stop oral hygiene at the study site for 2 weeks.
Sulcus fluid and plaque samples will be taken at the abutment site at several visits before and during abdication of oral hygiene.
The study finishes with biopsy visit. Afterwards a regular abutment will be placed and the patients will be treated according to the standard protocol of the clinic to obtain their final restoration
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ESTA abutment Roxolid | Other | One study abutment per patient will be placed. After healing for 6 to 7 weeks, patients will be asked to stop oral hygiene at the study site for 2 weeks. Sulcus fluid and plaque samples will be taken at the abutment site at several visits before and during abdication of oral hygiene. The study finishes with biopsy visit. Afterwards a regular abutment will be placed and the patients will be treated according to the standard protocol of the clinic to obtain their final restoration. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ESTA abutment Roxolid | Device | Enhanced Soft Tissue Attachment surface on Roxolid or machined surface on Roxolid abutment placement. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of Myeloperoxidase level as indicator for inflammatory reactions on modified surface abutments compared to machined surface abutments. | A biopsy will be taken at study day 70. The study abutment will be removed together with a small slice of the surrounding soft tissue to histologically evaluation. | Inflammation assessment and biopsy at study day 70. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of myeloperoxidase level of modified surface abutments compared to machined surface abutment at visit 2, 3, 4, and 6. | A immunology sample will be taken 2-3 weeks after abutment placement, followed on week 6-7, week 8, week 9, and at week 20-24. | 20-24 weeks |
| evaluation of inflammatory parameters of modified surface abutment compared to machined surface abutments |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anton Sculean, Dr med dent | University Bern, Zahnmedizinische Kliniken Bern | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universität Bern | Bern | Canton of Bern | 3010 | Switzerland |
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| ID | Term |
|---|---|
| D016388 | Tooth Loss |
| D009066 | Mouth, Edentulous |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D014076 | Tooth Diseases |
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A immunology sample will be taken 2-3 weeks after abutment placement, followed on week 6-7, week 8, week 9, and at week 20-24. |
| 20-24 weeks |
| Evaluation of clinical inflammatory parameters of modified surface abutments compared to machined surface abutments based on modified Mombelli plaque index and modified Lobene gingival index. | A immunology sample will be taken 2-3 weeks after abutment placement, followed on week 6-7, week 8, week 9, and at week 20-24. | 20-24 weeks |
| Evaluation of subgingival plaque extension of modified surface abutments compared to machined surface abutments | Patients will be asked to suspend oral hygiene in the area of the abutment. after 42-49 days after abutment placement for 14 days. At study week 8 a histological sample will be taken | 9 weeks after abutment placement |
| Evaluation of soft tissue around the abutment of modified surface abutment compared to machined surface abutments | 8 weeks after abutment placement patients have been asked for 14 days of abdication of oral hygiene. A histological sample will be taken then. | At 8 weeks after abutment placement |
| Evaluation of bacterial community at the abutment site | At study day 42-49, day 49-56, day 56-63, and day 77-105 a microbiological sample will be taken | 28 days |