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

Partial-edentulism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04929743
• Other study ID #: BTI_02_EC/20/4.5
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 11, 2021
• Est. completion date: July 31, 2023

Study information

• Verified date: July 2022
• Source: Fundación Eduardo Anitua
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 15
• Est. completion date: July 31, 2023
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Partial-edentulism

Intervention

Device:
• BTI Implant
Placement of dental implants of 5.5 vs >6.5 mm length

Locations

Country	Name	City	State
Spain	Clinica Eduardo Anitua	Vitoria

Sponsors (1)

Lead Sponsor	Collaborator
Fundación Eduardo Anitua

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival of implants	Survival of implants at one year post-implantation	1 year
Secondary	Marginal bone loss	Marginal bone loss at one year post-implantation	1 year
Secondary	Incidence of bleeding on probing		1 year
Secondary	Incidence of prosthetic or implant complications		1 year
Secondary	Probing pocket depth		1 year