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

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: Active, not recruiting
• Conditions: Partial-edentulism
• Intervention / Treatment: Device: BTI Implant

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Vitoria, Spain
    • Clinica Eduardo Anitua

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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

How is the study designed?

Design Details

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

Number of Arms

2

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	Survival of implants at one year post-implantation	1 year

Secondary Outcome Measures

Outcome Measure	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
Incidence of bleeding on probing		1 year
Probing pocket depth		1 year

Collaborators and Investigators

• Sponsor: Fundación Eduardo Anitua

Study record dates

Study Major Dates

• Study Start (Actual): May 11, 2021
• Primary Completion (Anticipated): July 1, 2023
• Study Completion (Anticipated): July 31, 2023

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): July 8, 2022
• Last Update Submitted That Met QC Criteria: July 6, 2022
• Last Verified: July 1, 2022

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