Dental Implants With a SLActive® vs. SLA® Surface

NCT ID: NCT03737357

Last Updated: 2025-06-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-09
• Study Completion Date: 2023-06-23

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.

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.

Conditions

Partially Edentulous Patients

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

SLActive® implant

Group Type: EXPERIMENTAL

SLActive® implant

Intervention Type: 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

Group Type: ACTIVE_COMPARATOR

SLA® implant

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut Straumann AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mariano Sanz, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Professor and Chairman of Periodontology

Juan Blanco-Carrión, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Professor in Periodontology

Locations

Universidad Complutense

Madrid, , Spain

Universidad de Santiago de Compostela

Santiago de Compostela, , Spain

Countries

Spain

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CR 2017-05

Identifier Type: -

Identifier Source: org_study_id