Randomized Clinical Trial to Evaluate the Predictability of 5.5 mm Dental Implants

February 24, 2025 updated by: Fundación Eduardo Anitua

Randomized Clinical Trial to Evaluate the Predictability and Evolution of Extra-short 5.5 mm Dental Implants Splinted in Partial or Complete Prostheses

The main aim of this clinical trial is to analyze the survival rate of short-length implants (<4.5 mm) in partial edentulism subjects. 6.5 mm length implants will be used as control arm. Additionally, others clinical parameters (marginal bone loss and prosthetic associated complications) will be measured.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Vitoria, Spain
        • Clinica Eduardo Anitua

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥ 18 years
  • Clinical indication to place a prosthetic bridge supported by a maximum of 4 implants in the posterior sectors
  • Bone height in the area of interest sufficient to place implants 6.5mm length dental implants
  • Availability to be observed during the follow-up period
  • Signature of the informed consent

Exclusion Criteria:

  • Need to perform bone augmentation surgery prior to implant placement surgery
  • Smokers (> 10 cigarettes per day)
  • Patients with poorly controlled diabetes
  • Patients on chronic treatment with non-steroidal anti-inflammatory drugs
  • Patients receiving oral or intravenous bisphosphonates
  • Patients under chemotherapy or radiotherapy treatment
  • Patients receiving systemic corticosteroids

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 5.5 mm implants
Device: BTI Implant
Placement of dental implants of 5.5 vs >6.5 mm length
Active Comparator: >6.5 mm implants
Device: BTI Implant
Placement of dental implants of 5.5 vs >6.5 mm length

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Marginal bone loss
Time Frame: 1 year
Marginal bone loss at one year post-implantation
1 year
Incidence of prosthetic or implant complications
Time Frame: 1 year
1 year
Incidence of bleeding on probing
Time Frame: 1 year
1 year
Probing pocket depth
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación Eduardo Anitua

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 11, 2021

Primary Completion (Actual)

November 27, 2024

Study Completion (Actual)

November 27, 2024

Study Registration Dates

First Submitted

June 9, 2021

First Submitted That Met QC Criteria

June 15, 2021

First Posted (Actual)

June 18, 2021

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 24, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • BTI_02_EC/20/4.5

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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