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

Narrow Dental Implants in Multiple Fixed Prosthesis

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Edentulous Alveolar Ridge
• Intervention / Treatment: Device: Narrow dental implants

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Vitoria, Spain
    • Clínica Dental Eduardo Anitua

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Narrow dental implants in multiple fixed prosthesis	Device: Narrow dental implants; Insertion of narrow dental implants in multiple fixed prosthesis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival after 5 years of follow-up	Implant survival after 5 years of follow-up	5 years in comparison with the baseline

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Fundación Eduardo Anitua
• Collaborators: BTI S.L

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2019
• Primary Completion (Anticipated): January 31, 2026
• Study Completion (Anticipated): January 31, 2026

Study Registration Dates

• First Submitted: July 1, 2019
• First Submitted That Met QC Criteria: July 1, 2019
• First Posted (Actual): July 5, 2019

Study Record Updates

• Last Update Posted (Actual): September 16, 2021
• Last Update Submitted That Met QC Criteria: September 14, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: edentulous; narrow alveolar ridges
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Tooth Diseases; Mouth, Edentulous
• Other Study ID Numbers: FIBEA_02_EC_19_Estrechos

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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