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Clinical Trials/NCT04006782
NCT04006782
Active, Not Recruiting
N/A

Narrow Dental Implants in Multiple Fixed Prosthesis

Fundación Eduardo Anitua1 site in 1 country48 target enrollmentAugust 1, 2019

Overview

Phase
N/A
Intervention
Not specified
Conditions
Edentulous Alveolar Ridge
Sponsor
Fundación Eduardo Anitua
Enrollment
48
Locations
1
Primary Endpoint
Survival after 5 years of follow-up
Status
Active, Not Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 1, 2019
End Date
January 31, 2026
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Fundación Eduardo Anitua
Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

Survival after 5 years of follow-up

Time Frame: 5 years in comparison with the baseline

Implant survival after 5 years of follow-up

Secondary Outcomes

  • Marginal Bone Loss(1, 3 and 5 years in comparison with the baseline)

Study Sites (1)

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