Extra-short vs. Non-extra-short Dental Implants Splinted on the Same Prosthesis

Partial-edentulism Clinical Trial

Official title:

Prospective Observational Study on Evolution of Extra-short Implants (<6.5 mm) Compared to Non-extra-short Implants (≥ 6.5 mm) Splinted on the Same Prosthesis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04927819
• Other study ID #: FIBEA_02_EP/20/Extracortos
• Status: Active, not recruiting
• Start date: May 11, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: July 2022
• Source: Fundación Eduardo Anitua
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The main aim of this prospective study is to analyze the survival rate of short-length implants (<6.5 mm) in subjects with partial edentulism. Non-short length implant will be used as control arm. Additionally, others clinical parameters (marginal bone loss and prosthetic associated complications) will be measured.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 102
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18 years
• Have planned a fixed multiple prosthesis supported by implants <6.5 mm in length and implants = 6.5 mm in length within 15 days before the inclusion of the patient in the study.
• Planning of supported prostheses from 2 to 4 implants dental
• Have a previously performed CBCT (Cone Beam Computed Tomography)
• Availability to be observed during the period of tracing
• Signature of the informed consent

Exclusion Criteria:

• Smokers> 10 cigarettes / day
• Complete prostheses
• Unitary prostheses

Related Conditions & MeSH terms

• Partial-edentulism

Intervention

Device:
• BTI Implant
BTI Dental implants are non-active medical device, single use, non resterilizable, biocompatible and sterile devices made of alloplastic materials (Titanium) intended to be surgically implanted into alveolar and/or basal bone of the mandible or maxilla to provide support and a means of retention for a dental prosthesis (e.g. bridge, single-tooth, overdenture).

Locations

Country	Name	City	State
Spain	Clinica Eduardo Anitua	Vitoria

Sponsors (1)

Lead Sponsor	Collaborator
Fundación Eduardo Anitua

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival of dental implants	Survival of dental implants at one year post-implantation	1 year
Secondary	Marginal bone loss	Marginal bone loss at one year post-implantation	1 year
Secondary	Incidence of prosthetic or implant complications		1 year