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

Sponsor
Fundación Eduardo Anitua (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04927819
Collaborator
(none)
102
Enrollment
1
Location
31.7
Anticipated Duration (Months)
3.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: BTI Implant

Study Design

Study Type:
Observational
Anticipated Enrollment :
102 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
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
Actual Study Start Date :
May 11, 2021
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm 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).

Outcome Measures

Primary Outcome Measures

  1. Survival of dental implants [1 year]

    Survival of dental implants at one year post-implantation

Secondary Outcome Measures

  1. Marginal bone loss [1 year]

    Marginal bone loss at one year post-implantation

  2. Incidence of prosthetic or implant complications [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Clinica Eduardo Anitua Vitoria Spain

Sponsors and Collaborators

  • Fundación Eduardo Anitua

Investigators

  • Principal Investigator: Eduardo Anitua, MD, Clinica Eduardo Anitua

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Fundación Eduardo Anitua
ClinicalTrials.gov Identifier:
NCT04927819
Other Study ID Numbers:
  • FIBEA_02_EP/20/Extracortos
First Posted:
Jun 16, 2021
Last Update Posted:
Jul 7, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes

Study Results

No Results Posted as of Jul 7, 2022