Extra-short vs. Non-extra-short Dental Implants Splinted... | NCT04927819

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

NCT04927819

Sponsor

Fundación Eduardo Anitua

Status

Recruiting

Last Update Posted

Apr 17, 2025Actual

Enrollment

102Estimated

Phase

Not provided

Conditions

Partial-edentulism

Interventions

BTI Implant

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 11, 2021Actual

Primary Completion Date

May 12, 2022Actual

Completion Date

Jul 31, 2025Estimated

First Submitted Date

Jun 9, 2021

First Submission Date that Met QC Criteria

Jun 9, 2021

First Posted Date

Jun 16, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 16, 2025

Last Update Posted Date

Apr 17, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

102Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
short-length implant (<6.5 mm)			Device: BTI Implant
non-short length implant (≥6.5 mm)			Device: BTI Implant

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BTI Implant	Device	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).

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Marginal bone loss	Marginal bone loss at one year post-implantation	1 year
Incidence of prosthetic or implant complications		1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Partial edentulism

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mikel Allende, PhD	Contact	+34945160653	257	mikel.allende@bti-implant.es
Mikel Allende	Contact	+34945160653	257	mikel.allende@bti-implant.es

Overall Officials

Name	Affiliation	Role
Eduardo Anitua, MD	Clinica Eduardo Anitua	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clinica Eduardo Anitua	Recruiting	Vitoria-Gasteiz			Spain

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided