Dental Implants With a SLActive® vs. SLA® Surface

NCT03737357 | Completed Results

• 1 other identifier: CR 2017-05
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Partially Edentulous Patients

Keywords

dental implants; SLActive® surface; biomarkers; BLT implant

Outcome Measures

Primary Outcomes (2)

• Bone Level Change 12 Months After Implant Loading

  The primary efficacy objective of this study was to confirm the performance of the SLActive® implants by means of bone level change 12 months after implant loading, as described in the CIP (CR2017-05, v03).

  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 Outcomes (3)

• Change in Inflammatory and Anti-inflammatory Biomarkers Concentrations

  At implant placement, 1 and 4 weeks after implant placement

• Change in Osseointegration Biomarkers Concentrations

  1, 2, 4 and 8 weeks after implant placement

• Implant Survival

  12 months after implant loading

Study Arms (2)

SLActive® implant

EXPERIMENTAL

Device: SLActive® implant

SLA® implant

ACTIVE COMPARATOR

Device: SLA® implant

Interventions

SLActive® implant DEVICE

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.

SLActive® implant

SLA® implant DEVICE

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.

SLA® implant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut Straumann AG: lead

Study Sites (2)

Universidad Complutense

Madrid, Spain

Location

Universidad de Santiago de Compostela

Santiago de Compostela, Spain

Location

Results Point of Contact

• Title: Anaïs Robert, Clinical Trial Leader
• Organization: Institut Straumann

anais.robert@straumann.com

+41799258750

Study Officials

• Mariano Sanz, Prof. Dr.

  Professor and Chairman of Periodontology

  PRINCIPAL INVESTIGATOR

• Juan Blanco-Carrión, Prof. Dr.

  Professor in Periodontology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2018
• First Posted: November 9, 2018
• Study Start: October 9, 2019
• Primary Completion: March 9, 2023
• Study Completion: June 23, 2023
• Last Updated: June 12, 2025
• Results First Posted: June 12, 2025

Record last verified: 2025-02

Locations

ES (2)