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

Not Applicable

Completed

• Conditions: Partial-edentulism
• Interventions: Device: BTI Implant

• Registration Number: NCT04929743
• Lead Sponsor: Fundación Eduardo Anitua

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-11
• Study First Submitted: 2021-06-09
• Study First Submitted QC: 2021-06-15
• Study First Posted: 2021-06-18
• Primary Completion: 2024-11-27
• Study Completion: 2024-11-27
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-24
• Last Update Posted: 2025-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
5.5 mm implants	BTI Implant	-
>6.5 mm implants	BTI Implant	-

Primary Outcome Measures

Name	Time	Method
Survival of implants	1 year	Survival of implants at one year post-implantation

Secondary Outcome Measures

Name	Time	Method
Incidence of prosthetic or implant complications	1 year
Incidence of bleeding on probing	1 year
Marginal bone loss	1 year	Marginal bone loss at one year post-implantation
Probing pocket depth	1 year

Trial Locations

Locations (1)

Clinica Eduardo Anitua; 🇪🇸 Vitoria, Spain