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

NCT ID: NCT04006782

Last Updated: 2025-02-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-01

Study Completion Date

2026-01-31

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.

Detailed Description

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Conditions

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Edentulous Alveolar Ridge

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Narrow dental implants in multiple fixed prosthesis

Group Type OTHER

Narrow dental implants

Intervention Type DEVICE

Insertion of narrow dental implants in multiple fixed prosthesis

Interventions

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Narrow dental implants

Insertion of narrow dental implants in multiple fixed prosthesis

Intervention Type DEVICE

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,
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fundación Eduardo Anitua

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Clínica Dental Eduardo Anitua

Vitoria-Gasteiz, , Spain

Site Status

Countries

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Spain

Other Identifiers

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FIBEA_02_EC_19_Estrechos

Identifier Type: -

Identifier Source: org_study_id

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