Comparison Between Ultra-narrow Diameter Implants (2,75 mm) Without Bone Regeneration Versus Standard Diameter Implants (4,3 mm) in Combination With Bone Regeneration

Dental Implant Clinical Trial

Official title:

Éxito a Corto Plazo de Los Implantes Ultra-estrechos (2,75 mm) en comparación Con Implantes de Plataforma Regular (4,3 mm) Que Requieren regeneración ósea Vestibular simultánea. Ensayo clínico Aleatorizado

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03225495
• Other study ID #: 39/2016
• Status: Recruiting
• Phase: N/A
• First received: July 18, 2017
• Last updated: January 15, 2018
• Start date: July 1, 2017
• Est. completion date: July 1, 2019

Study information

• Verified date: January 2018
• Source: University of Barcelona
• Contact: Rui Figueiredo, PhD
• Phone: 00 34 93 402 42 74
• Email: ruipbfigueiredo[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main target of the study is to compare ultra-narrow diameter implants (2.75 mm) without bone regeneration versus standard diameter implants (4.3 mm) in combination with bone regeneration. To do so, patients with missing upper central incisors, canines, first or second premolars with alveolar ridges of 6 - 8 mm of thickness will be restored with dental implants. Cone beam computed tomographic examination and clinical values will be registered before and after the surgical procedure at 6 and 12 months.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: July 1, 2019
• Est. primary completion date: July 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• One missing teeth in position: upper central incisor, canine or premolar

• alveolar ridge thickness of 6 - 8 mm

• alveolar ridge height of = 10 mm

Exclusion Criteria:

• Missing data

• ASA = III

Related Conditions & MeSH terms

• Dental Implant
• Guided Bone Regeneration
• Implant Fracture
• Narrow Implant

Intervention

Procedure:
• Standard implant
Arm - Standard Implant: implant placement in combination with guided bone regeneration;
• Ultra-narrow implant
Arm - Ultra-narrow implant: implant placement without guided bone regeneration

Locations

Country	Name	City	State
Spain	Hospital Odontològic - Universitat de Barcelona	L'Hospitalet de Llobregat

Sponsors (3)

Lead Sponsor	Collaborator
University of Barcelona	Adin Implants, Geistlich Pharma AG

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success	According to criteria described by Albrektsson et al. 1986	12 months