Narrow Dental Implants in Multiple Fixed Prosthesis: A Controlled Clinical Trial

Study Overview
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Brief Summary
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The objective of this study is to evaluate the survival of narrow dental implants (≤ 3,5 mm) in multiple fixed prostheses in comparison with standard diameter dental implants (≥ 3,75 mm) after 5 years of follow-up. The hypothesis of the study is that narrow dental implants under the evaluated conditions, have the same survival rate and clinical performance than the standard diameter implants.

Official Title
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Narrow Dental Implants in Multiple Fixed Prosthesis

Conditions
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Edentulous Alveolar Ridge

Intervention / Treatment
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* Device: Narrow dental implants


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients of legal age (>18 years) of both sexes. Clinical need of multiple fixed alveolar ridge rehabilitations. Clinical suitability to insert, at least, one narrow dental implant splinted to a standard diameter dental implant. Signature of the informed consent Exclusion Criteria: Presence of an active infection Being under active treatment with, or have received in the las 30 days treatment with radiotherapy, chemotherapy, immunosuppressors, systemic corticosteroids and/or anticoagulants. Presence of severe haematologic disorders. Chronic treatment with non steroidal anti-inflammatory drugs (NSAID) or other aniinflammatory drugs. Previous diagnosis of chronic hepatitis or liver cirrhosis. Presence of Diabetes mellitus with improper metabolic control (glycosylated haemoglobine higher that 9%). Patients subjected to dialysis. Presence of malignant tumours, haemangioma or angioma in the surgical area. History of ischaemic cardiopathy in the las year. Pregnancy or plan to getting pregnant during the study. Metabolic bone disease Patientd receiving treatment with oral or intravenous biphosphonates. Any other condition incompatible with the participation in the study,

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Narrow dental implants in multiple fixed prosthesis<br> | Device: Narrow dental implants<br>* Insertion of narrow dental implants in multiple fixed prosthesis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival after 5 years of follow-up | Implant survival after 5 years of follow-up | 5 years in comparison with the baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Marginal Bone Loss | Evolution of the peri-implant bone level along the study follow up | 1, 3 and 5 years in comparison with the baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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edentulous, narrow alveolar ridges