Missing teeth Dental implants, missing teeth
Conditions
Interventions
This study will use the implant components, which are commercially available and used in routine dental implant procedures. A Laser induced surface modification will be used to recreate the multiscale
Experimental Device
Surface modified healing abutment and commercially available healing abutments
Sponsors
Straumann Group
Eligibility
Sex/Gender
All
Age
25 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Have a minimum of 2 missing teeth in maxilla or mandible. 2. Have least one of the six probing sites per tooth having pocket depth of 2-3 mm, and radiographic evidence of alveolar bona volume sufficient to place implants without bone augmentation. 3. Willingness to comply with all study procedures and be available for the duration of the study.
Exclusion criteria
Exclusion criteria: 1. Gross oral pathology, including widespread caries or chronic neglect, extensive restoration, pre-existing gross plaque or calculus, or soft or hard tissue tumour of the oral cavity. 2. Chronic disease with concomitant oral manifestations (e.g., diabetes [irrespective of level of control], human immunodeficiency virus infection or acquired immunodeficiency syndrome). 3. Individuals with history of splenectomy, known immune disorders (e.g., systemic lupus erythematosus, rheumatoid arthritis), or receiving immunosuppressives (e.g., substances or treatments known to diminish the immune response such as radiation therapy, administration of antimetabolites, antilymphocytic sera, systemic corticosteroids). Individuals who have received periodic treatments with immunosuppressives, defined as at least 3 courses of oral corticosteroids each lasting at least 1 week in duration for the year prior to enrolment, are excluded. Participants using topical steroids (i.e., inhaled or nasal) are eligible to participate. 4. Individuals who are immunocompromised or have been diagnosed as having Human Immunodeficiency Virus (HIV) infection. 5. Receipt of inactivated vaccines within 14 days prior to enrolment or receipt of live virus vaccines within 21 days prior to enrolment. 6. Participation in a clinical study testing a drug, biologic, device, or other intervention within the last six months. 7. Concomitant pharmacotherapy with drugs that may affect the outcome of the periodontal treatment. 8. Any medical conditions or significant laboratory abnormalities that the investigator considers significant and that may compromise the individuals safety. 9. Pregnancy or lactation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Microbial response 15 weeks after the intervention Assays,Clinical observation 8,10,11 and 14 weeks Periodontal index | — |
Secondary
| Measure | Time frame |
|---|---|
| Bone response 8,10,11 and 14 weeks Radiographic | — |
Countries
Australia
Contacts
Public ContactStephanie Anderson
Melbourne University Publishing
Outcome results
None listed