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| Name | Class |
|---|---|
| University of Kiel | OTHER |
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There is a significant difference between CM LOC and ball attachment, when considering the peri-implant soft tissue health and marginal bone loss. The primary and secondary objectives are to determine if CM LOC attachment improves the peri-implant soft tissue response and decreases the marginal bone loss around implant when compared to conventional ball attachment
Ball attachments are very commonly used because they are solitary, simple, easier to use and less technique sensitive if compared to bar attachments. However, ball attachment require a prosthetic space of 12 mm and could show tremendous wear if implants were mal-aligned. CM LOC attachment is newly introduced into market with very good expectations regarding its properties and effect on the periimplant soft tissue. CM LOC attachment, which combes titanium patrix and resin matrix made from polyetherketoneketone (PEKK), is a very promising material regarding the wear and the prosthesis retention it provides, even with mal-aligned implants. However, the clinical performance of this attachment was not tested yet. Therefore, in this randomized controlled trial it was decided to compare between CM LOC and the commonly used ball attachment regarding the soft tissue health and marginal bone loss.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ball attachment | Active Comparator | completely edentulous patients having single median mandibular implant to retain mandibular overdenture.the attachment used is the conventional ball attachment |
|
| CM LOC attachment | Experimental | completely edentulous patients having single median mandibular implant to retain mandibular overdenture.the attachment used is the cm loc attachment |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ball attachment | Device | it is attachment part that connects the overdenture to the implant |
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| Measure | Description | Time Frame |
|---|---|---|
| Soft tissue reaction :Presence of mucositis | it is a binary outcome that is measured by either its presence or absence | [from baseline up to 1 year] |
| Measure | Description | Time Frame |
|---|---|---|
| Modified gingival Index | 0 = absence of inflammation
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ahmed sherif, Msc | Contact | 00201002130130 | ahmed.sherif@dentistry.cu.edu.eg | |
| Hassan ahmed | Contact | 0020105009014 | Hassan.ahmed@dentistry.cu.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| nouran abdelnaby, phd | prosthodontic department-faculty of dentistry-cairo university | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Outpatient Clinic-Prosthodontic Department-Faculty of Dentistry-Cairo University | Recruiting | Giza | Egypt |
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| cm loc attachment | Device | It is a new attachment made of peek material |
|
| from baseline up to 1 year. score measurement from 0-4 where 0 is no inflammation and 4 is severe inflammation |
| Modified Plaque Index | Modified Plaque Index (mPI) is a dental plaque scale done by Mombelli etal.[13] as follows: 0 = No plaque
| from baseline upto 1 year. score measurement from 0-3 where 0 denotes no plaque present and 3 denotes abundant plaque |
| Modified Bleeding Index | Periodontal probe will be passed all around implant cervical margin and bleeding will be scored as follows: Score 0: No bleeding when a periodontal probe is passed along the gingival margin adjacent to the implant. Score 1: Isolated bleeding spots visible. Score 2: Blood forms a confluent red line on margin. Score 3: Heavy or profuse bleeding. | from baseline upto 1 year. score from 0-3 where 0 denotes no bleeding and 3 denotes profound bleeding |
| marginal bone loss | Standardized periapical long cone paralleling technique will be necessary so radiographic template customized for each patient with a holder. Then two reference points will be marked on the implant platform surface and will be joined with a line representing the height zero. then two vertical lines mesial and distal will be drawn to the first bone contact point. | from baseline up to 1 year |