NCT04073654

SA Versus SOI Surfaces for Single Implant-supported Crown

Clinical Evaluation and Primary Stability of Early Loaded Implants With Sandblasted and Acid-etched Surface Versus Implants With SA Surface Modified With pH Buffering Agent: a Multicenter Randomized Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Osstem AIC · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this randomized controlled trial is to compare clinical data and implant stability of immediately loaded TSIII Osstem implants with Sandblasted and Acid-etched (SA) surface versus implants with SA surface modified with pH buffering agent for the rehabilitation of single implant-supported crown.

Detailed description

This study aimed to evaluate if there are some benefits using novel implant surface. This surface should improve the secondary implant stability, reducing the overall time needed for the osseointegration. main benefits in clinical practice should be reduced treatment time.

Conditions

• Dental Implant Failed
• Bone Resorption

Interventions

Type	Name	Description
PROCEDURE	Placement of dental implants (surgical procedure)	The two study implants have to be placed in the same surgical session according to similar procedures. Implants will be placed in the planned anatomic sites by using a flapless or a miniflap approach. Implants sites will be prepared based on the bone density, and according to the manufacturers's instruction by using the 122 Taper kit (Osstem Implant).

Timeline

• Start date: 2019-09-26
• Primary completion: 2020-09-30
• Completion: 2021-10-15
• First posted: 2019-08-29
• Last updated: 2019-10-01

Locations

10 sites across 8 countries: Albania, Bulgaria, Italy, Poland, Portugal, Romania, South Africa, Switzerland