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

Edentulous Alveolar Ridge Clinical Trial

Official title:

Narrow Dental Implants in Multiple Fixed Prosthesis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04006782
• Other study ID #: FIBEA_02_EC_19_Estrechos
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 1, 2019
• Est. completion date: January 31, 2026

Study information

• Verified date: September 2021
• Source: Fundación Eduardo Anitua
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 48
• Est. completion date: January 31, 2026
• Est. primary completion date: January 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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,

Related Conditions & MeSH terms

• Edentulous Alveolar Ridge
• Mouth, Edentulous

Intervention

Device:
• Narrow dental implants
Insertion of narrow dental implants in multiple fixed prosthesis

Locations

Country	Name	City	State
Spain	Clínica Dental Eduardo Anitua	Vitoria

Sponsors (2)

Lead Sponsor	Collaborator
Fundación Eduardo Anitua	BTI S.L

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival after 5 years of follow-up	Implant survival after 5 years of follow-up	5 years in comparison with the baseline
Secondary	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