NCT04929743

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

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
9 days until next milestone

First Posted

Study publicly available on registry

June 18, 2021

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 27, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 27, 2024

Completed
Last Updated

February 25, 2025

Status Verified

February 1, 2025

Enrollment Period

3.6 years

First QC Date

June 9, 2021

Last Update Submit

February 24, 2025

Conditions

Partial-edentulism

Outcome Measures

Primary Outcomes (1)

  • Survival of implants

    Survival of implants at one year post-implantation

    1 year

Secondary Outcomes (4)

  • Marginal bone loss

    1 year

  • Incidence of bleeding on probing

    1 year

  • Incidence of prosthetic or implant complications

    1 year

  • Probing pocket depth

    1 year

Study Arms (2)

5.5 mm implants

EXPERIMENTAL
Device: BTI Implant

>6.5 mm implants

ACTIVE COMPARATOR
Device: BTI Implant

Interventions

BTI ImplantDEVICE

Placement of dental implants of 5.5 vs \>6.5 mm length

5.5 mm implants>6.5 mm implants

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinica Eduardo Anitua

Vitoria-Gasteiz, Spain

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2021

First Posted

June 18, 2021

Study Start

May 11, 2021

Primary Completion

November 27, 2024

Study Completion

November 27, 2024

Last Updated

February 25, 2025

Record last verified: 2025-02

Locations

ES(1)