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

NCT04006782 | Active Not Recruiting

• 1 other identifier: FIBEA_02_EC_19_Estrechos
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Edentulous Alveolar Ridge

Keywords

edentulous; narrow alveolar ridges

Outcome Measures

Primary Outcomes (1)

• Survival after 5 years of follow-up

  Implant survival after 5 years of follow-up

  5 years in comparison with the baseline

Secondary Outcomes (1)

• Marginal Bone Loss

  1, 3 and 5 years in comparison with the baseline

Study Arms (1)

Narrow dental implants in multiple fixed prosthesis

OTHER

Device: Narrow dental implants

Interventions

Narrow dental implants DEVICE

Insertion of narrow dental implants in multiple fixed prosthesis

Narrow dental implants in multiple fixed prosthesis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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,

Sponsors & Collaborators

• Fundación Eduardo Anitua: lead

Study Sites (1)

Clínica Dental Eduardo Anitua

Vitoria-Gasteiz, Spain

Location

MeSH Terms

Conditions

Mouth, Edentulous

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Tooth Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2019
• First Posted: July 5, 2019
• Study Start: August 1, 2019
• Primary Completion: January 31, 2026
• Study Completion: January 31, 2026
• Last Updated: February 27, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)