Dental Implants With a SLActive® vs. SLA® Surface

A Randomized Controlled Study to Assess Intra-patient Clinical Performance of Dental Implants With a SLActive® vs. SLA® Surface

This post-market study is to show that dental implants with a SLActive® surface (SLActive® implants) show non-inferior clinical performance compared to dental implants with a SLA® surface (SLA® implants). The primary hypothesis is that 12 months after implant loading, the bone loss around the SLActive® implants will not be appreciably greater than around the SLA® implants.

The occurrence of adverse events and device deficiencies will also be recorded to confirm once more the safety of the Straumann® Bone Level Tapered (BLT), Roxolid® implant.

Osseointegration and anti-inflammatory potential of SLActive® implants will be evaluated in the study as secondary endpoints.

Study Overview

• Status: Active, not recruiting
• Conditions: Partially Edentulous Patients
• Intervention / Treatment: Device: SLActive® implant; Device: SLA® implant

Detailed Description

This is a prospective, single-blinded, randomized, paired sample, multi-center clinical study. Eight visits per patient are scheduled in this study. The final analysis will be conducted after all patients completed the 12-month visit.

The study devices are CE- (Conformité Européenne, meaning European Conformity) marked products and used within their intended use.

Two centers in Spain will participate.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain
    • Universidad Complutense
  • Santiago De Compostela, Spain
    • Universidad de Santiago de Compostela

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• males and females, at least 18 years old
• partially edentulous patients in need of two or more dental implants (canine to molars) placed in two different quadrants in healed sites (3 months post extraction)
• subject must have voluntarily signed the informed consent, is willing and able to attend scheduled follow-up visits, and agrees that the encoded data will be collected and analyzed

Exclusion Criteria:

• any contraindications for oral surgical procedures
• dental implant placement contraindicated according to Instructions for Use (IFU)
• subjects with inadequate oral hygiene (FMPS ≥ 20%)
• subjects who are currently heavy smokers (defined >10 cigarettes per day or >1 cigar per day) or who use chewing tobacco
• subjects with drug or alcohol abuse
• patients requiring soft tissue and bone grafting procedures
• inadequate bone volume
• severe bruxism or clenching habits
• women who are pregnant or planning to become pregnant at any point during the study duration.
• patients who have systemic factors that could interfere with the healing process of either bone or soft tissue or the osseointegration process (e.g. bone metabolism disturbances, uncontrolled diabetes mellitus, anticoagulation drugs/ hemorrhagic diatheses)
• patients with local factors that could interfere with the healing process, such as untreated periodontal diseases, acute infection of implant site, temporomandibular joint disorders, treatable pathologic diseases of the jaw and changes in the oral mucosa)
• conditions or circumstances, in the opinion of the investigator, which would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance, or unreliability.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SLActive® implant	Device: SLActive® implant; One study test (SLActive® surface) (and simultaneously, in a split-mouth design one study control (SLA® surface) implant (Bone Level Tapered, Roxolid®)) will be placed in two different quadrants of partially edentulous patients. The implants will be placed at premolars, molars and canine positions in the mandible and maxilla (healed extraction sites). Implants will be restored with a single crown or splinted restorations 8 weeks after implant placement.
Active Comparator: SLA® implant	Device: SLA® implant; One study test (SLActive® surface) (and simultaneously, in a split-mouth design one study control (SLA® surface) implant (Bone Level Tapered, Roxolid®)) will be placed in two different quadrants of partially edentulous patients. The implants will be placed at premolars, molars and canine positions in the mandible and maxilla (healed extraction sites). Implants will be restored with a single crown or splinted restorations 8 weeks after implant placement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bone Level Change	Bone level change at 12 months after implant loading	12 months after implant loading
Occurrence of adverse device effects and device deficiencies that could have led to a serious adverse device effect	Occurrence of adverse device effects and device deficiencies that could have led to a serious adverse device effect	12 months after implant loading

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bone Level Change	Bone Level Change between implant placement and loading and between loading and 12 months after implant loading	between implant placement and loading and between loading and 12 months after implant loading
Change in inflammatory and anti-inflammatory biomarkers concentrations	Change in inflammatory and anti-inflammatory biomarkers (IL-10, IL-4, IL-6, IL-1beta, TNF-alpha, IL-2) concentrations in gingival crevicular fluid samples.	30 days after implant placement
Change in osseointegration biomarkers concentrations	Change in osseointegration biomarkers ( VEGF, osteocalcin (OCN), osteopontin (OPN)) concentrations in gingival crevicular fluid samples.	between day 7 and 8 weeks after implant placement
Implant survival	Implant survival at 12 months after implant loading	12 months after implant loading

Collaborators and Investigators

• Sponsor: Institut Straumann AG
• Investigators: Principal Investigator: Mariano Sanz, Prof. Dr., Professor and Chairman of Periodontology; Principal Investigator: Juan Blanco-Carrión, Prof. Dr., Professor in Periodontology

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2019
• Primary Completion (Actual): March 9, 2023
• Study Completion (Anticipated): June 23, 2023

Study Registration Dates

• First Submitted: October 25, 2018
• First Submitted That Met QC Criteria: November 8, 2018
• First Posted (Actual): November 9, 2018

Study Record Updates

• Last Update Posted (Actual): March 31, 2023
• Last Update Submitted That Met QC Criteria: March 29, 2023
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: biomarkers; dental implants; SLActive® surface; BLT implant
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Tooth Diseases; Mouth, Edentulous
• Other Study ID Numbers: CR 2017-05

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No