Back to resultsNarrow Dental Implants in Multiple Fixed Prosthesis: A Controlled Clinical Trial
Primary Purpose
Edentulous Alveolar Ridge
Status
Active
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Narrow dental implants
Sponsored by
About this trial
This is an interventional treatment trial for Edentulous Alveolar Ridge focused on measuring edentulous, narrow alveolar ridges
Eligibility Criteria
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,
Sites / Locations
- Clínica Dental Eduardo Anitua
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Narrow dental implants in multiple fixed prosthesis
Arm Description
Outcomes
Primary Outcome Measures
Survival after 5 years of follow-up
Implant survival after 5 years of follow-up
Secondary Outcome Measures
Marginal Bone Loss
Evolution of the peri-implant bone level along the study follow up
Full Information
NCT ID
NCT04006782
First Posted
July 1, 2019
Last Updated
September 14, 2021
Sponsor
Fundación Eduardo Anitua
Collaborators
BTI S.L
1. Study Identification
Unique Protocol Identification Number
NCT04006782
Brief Title
Narrow Dental Implants in Multiple Fixed Prosthesis: A Controlled Clinical Trial
Official Title
Narrow Dental Implants in Multiple Fixed Prosthesis
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
January 31, 2026 (Anticipated)
Study Completion Date
January 31, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundación Eduardo Anitua
Collaborators
BTI S.L
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Edentulous Alveolar Ridge
Keywords
edentulous, narrow alveolar ridges
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Narrow dental implants in multiple fixed prosthesis
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
Narrow dental implants
Intervention Description
Insertion of narrow dental implants in multiple fixed prosthesis
Primary Outcome Measure Information:
Title
Survival after 5 years of follow-up
Description
Implant survival after 5 years of follow-up
Time Frame
5 years in comparison with the baseline
Secondary Outcome Measure Information:
Title
Marginal Bone Loss
Description
Evolution of the peri-implant bone level along the study follow up
Time Frame
1, 3 and 5 years in comparison with the baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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,
Facility Information:
Facility Name
Clínica Dental Eduardo Anitua
City
Vitoria
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Narrow Dental Implants in Multiple Fixed Prosthesis: A Controlled Clinical Trial
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