NCT04927819

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
102

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 11, 2021

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

June 9, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 16, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 12, 2022

Completed
3.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2025

Completed
Last Updated

April 17, 2025

Status Verified

April 1, 2025

Enrollment Period

1 year

First QC Date

June 9, 2021

Last Update Submit

April 16, 2025

Conditions

Partial-edentulism

Outcome Measures

Primary Outcomes (1)

  • Survival of dental implants

    Survival of dental implants at one year post-implantation

    1 year

Secondary Outcomes (2)

  • Marginal bone loss

    1 year

  • Incidence of prosthetic or implant complications

    1 year

Study Arms (2)

short-length implant (<6.5 mm)

Device: BTI Implant

non-short length implant (≥6.5 mm)

Device: BTI Implant

Interventions

BTI ImplantDEVICE

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)short-length implant (<6.5 mm)

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Partial edentulism

You may qualify if:

  • Age ≥ 18 years
  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinica Eduardo Anitua

Vitoria-Gasteiz, Spain

RECRUITING

Study Officials

  • Eduardo Anitua, MD

    Clinica Eduardo Anitua

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mikel Allende, PhD

CONTACT

+34945160653mikel.allende@bti-implant.es

Mikel Allende

CONTACT

+34945160653mikel.allende@bti-implant.es

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2021

First Posted

June 16, 2021

Study Start

May 11, 2021

Primary Completion

May 12, 2022

Study Completion

July 31, 2025

Last Updated

April 17, 2025

Record last verified: 2025-04

Locations

ES(1)