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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Partial-edentulism
• Intervention / Treatment: Device: BTI Implant

• Study Type: Observational
• Enrollment (Anticipated): 102

Contacts and Locations

Study Locations

• Spain
  • Vitoria, Spain
    • Clinica Eduardo Anitua

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Partial edentulism

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
short-length implant (<6.5 mm)	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).
non-short length implant (≥6.5 mm)	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival of dental implants	Survival of dental implants at one year post-implantation	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Marginal bone loss	Marginal bone loss at one year post-implantation	1 year
Incidence of prosthetic or implant complications		1 year

Collaborators and Investigators

• Sponsor: Fundación Eduardo Anitua
• Investigators: Principal Investigator: Eduardo Anitua, MD, Clinica Eduardo Anitua

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 11, 2021
• Primary Completion (ANTICIPATED): December 31, 2022
• Study Completion (ANTICIPATED): December 31, 2023

Study Registration Dates

• First Submitted: June 9, 2021
• First Submitted That Met QC Criteria: June 9, 2021
• First Posted (ACTUAL): June 16, 2021

Study Record Updates

• Last Update Posted (ACTUAL): July 7, 2022
• Last Update Submitted That Met QC Criteria: July 6, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: FIBEA_02_EP/20/Extracortos

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes