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OpenTrials
Completed

NCT Number: NCT04929743

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

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.

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Key information

Conditions

Partial-edentulism

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinica Eduardo Anitua

Vitoria-Gasteiz, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BTI Implant

Device

Placement of dental implants of 5.5 vs >6.5 mm length

Primary outcomes

  1. Survival of implants

    Time frame: 1 year

    Survival of implants at one year post-implantation

Secondary outcomes

  1. Marginal bone loss

    Time frame: 1 year

    Marginal bone loss at one year post-implantation

  2. Incidence of bleeding on probing

    Time frame: 1 year

  3. Incidence of prosthetic or implant complications

    Time frame: 1 year

  4. Probing pocket depth

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Fundación Eduardo Anitua

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jun 18, 2021
Registry last updated
Feb 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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