SA Versus SOI Surfaces for Single Implant-supported Crown

Osstem AIC

Status: Unknown

Conditions: Dental Implant Failed; Bone Resorption

Treatments: Procedure: Placement of dental implants (surgical procedure)

Study type: Interventional

Funder types: Other

Identifiers

NCT04073654

SOI_1_RCT_MT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Any partially edentulous subject requiring at least two single (preferable non-adjacent) implant-supported crowns, being at least 18 year old and able to sign an informed consent will be screened for eligibility. Bone volumes should allow the placement of two implants at least 8.5 mm (maximum 10 mm) long and 4.5 mm (minimum 3.5 mm) wide, with a minimal insertion torque of 30 Ncm. Implants can be placed in previous post-extractive socket or in augmented bone, if at least 4 to 6 months have passed from the extraction or from augmentation procedures.

Exclusion criteria

• Patients unable to commit to 5 years follow-up.
• General contraindications to implant surgery.
• Less then 4 mm of keratinised gingiva crestally (at the implant sites).
• Immune-suppressed/compromised patients.
• Patients irradiated in the head and/or neck.
• Uncontrolled diabetes.
• Pregnancy or lactation.
• Untreated periodontal disease.
• Poor oral hygiene and motivation (full mouth bleeding and full mouth plaque index higher than 25%).
• Addiction to alcohol or drugs.
• Psychiatric problems and/or unrealistic expectations.
• Patients with an acute infection or suppuration in the site intended for implant placement.
• Patients needing any form of tissue augmentation at implant placement.
• Immediate post-extractive implants (implants can be placed after a 3-month healing period).
• Patients treated or under treatment with intravenous amino-bisphosphonates.
• Patients referred only for implant placement if the follow-up cannot be done at the treatment center.
• Patients participating in other studies, if the present protocol could not be fully adhered to.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

100 participants in 2 patient groups

SA Implants

Active Comparator group

Description:

Dental implant with sandblasted and Acid-etched (SA) surface

Treatment:

Procedure: Placement of dental implants (surgical procedure)

SOI Implants

Experimental group

Description:

Same dental implant with sandblasted and Acid-etched surface modified with pH buffering agent

Treatment:

Procedure: Placement of dental implants (surgical procedure)