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

Not Applicable

Active, not recruiting

• Conditions: Edentulous Alveolar Ridge
• Interventions: Device: Narrow dental implants

• Registration Number: NCT04006782
• Lead Sponsor: Fundación Eduardo Anitua

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-07-01
• Study First Submitted QC: 2019-07-01
• Study First Posted: 2019-07-05
• Study Start: 2019-08-01
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-25
• Last Update Posted: 2025-02-27
• Primary Completion: 2026-01-31
• Study Completion: 2026-01-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 48

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,

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Narrow dental implants in multiple fixed prosthesis	Narrow dental implants	-

Primary Outcome Measures

Name	Time	Method
Survival after 5 years of follow-up	5 years in comparison with the baseline	Implant survival after 5 years of follow-up

Secondary Outcome Measures

Name	Time	Method
Marginal Bone Loss	1, 3 and 5 years in comparison with the baseline	Evolution of the peri-implant bone level along the study follow up

Trial Locations

Locations (1)

Clínica Dental Eduardo Anitua; 🇪🇸 Vitoria, Spain