Partially Edentulous PatientsNCT03737357

Dental Implants With a SLActive® vs. SLA® Surface

A study testing SLActive® implant and SLA® implant in people with Partially Edentulous Patients, run by Institut Straumann AG at 2 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Partially Edentulous Patients
What is being tested?: SLActive® implant and SLA® implant
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 70 participants
Where: 2 sitesSpain
Study dates: 9 Oct 2019to 23 Jun 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 12Show fewer

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.

Trial locations and contacts

2 sites in 1 country.

Spain2 sites

Universidad Complutense
Madrid
Universidad de Santiago de Compostela
Santiago de Compostela

Other trials in Spain

About this study

Official title: 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.

Read the 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
Being tested: SLActive® implant, SLA® implant
Keywords: dental implants, SLActive® surface, biomarkers, BLT implant

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SLActive® implantDevice
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® implantDevice
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.

Study groups in NCT03737357
Study group	Role	What they receive
SLActive® implant	Experimental	Not described Receives: Device: SLActive® implant
SLA® implant	Active comparator	Not described Receives: Device: SLA® implant

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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
Measured: 12 months after implant loading

Secondary outcomes (3)

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.
Measured: At implant placement, 1 and 4 weeks after implant placement
Change in Osseointegration Biomarkers Concentrations
Change in osseointegration biomarkers ( VEGF, osteocalcin (OCN), osteopontin (OPN)) concentrations in gingival crevicular fluid samples.
Measured: 1, 2, 4 and 8 weeks after implant placement
Implant Survival
Implant survival at 12 months after implant loading
Measured: 12 months after implant loading

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Oct 201923 Jun 2023

First posted9 Nov 2018
Study start9 Oct 2019
Primary completion9 Mar 2023
Study completion23 Jun 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Partially Edentulous PatientsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 70 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03737357
Sponsor's protocol ID: CR 2017-05
Status last verified: Feb 2025
First submitted: 25 Oct 2018
Last updated: 12 Jun 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Non-Guided vs. Guided Surgery to Immediately Loaded PrimeTaper Implants in Partially Edentulous Patients
Partially Edentulous Maxilla or Mandible
Not yet recruiting
Evaluation of Occlusal Contact Distribution in Digitally Fabricated Implant-Retained Fixed Partial Dentures in Mandibular Kennedy Class II Patients Following Artificial Intelligence Bite Optimization: A Quasi-Experimental Study
Partially Edentulous Mandible
Active, not recruitingObservational study
Masticatory Efficiency, Bite Force, and Patient-Reported Outcomes in Patients Rehabilitated With Complete and Partial Dentures Supported by Teeth, Mini-Implants, or Conventional Implants
Edentulism, Edentulism Complete
Recruiting
Clinical Safety and Effectiveness of the Straumann Dynamic Navigation System Falcon
Partially Edentulous Jaw, Tooth Loss
Active, not recruiting
Esthetic and Radiographic Outcomes Following Immediate Implant Placement With Thin or Dehiscence Buccal Bone Wall
Jaw, Edentulous, Partially, Acquired Absence of Single Tooth

All Partially Edentulous Patients trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Controlled Study to Assess Intra-patient Clinical Performance of Dental Implants With a SLActive® vs. SLA® Surface
ClinicalTrials.gov ID: NCT03737357
Acronym / sponsor ID: CR 2017-05
Conditions: Partially Edentulous Patients
Keywords: dental implants, SLActive® surface, biomarkers, BLT implant
Study type: Interventional
Recruitment status: Completed
Enrolment: 70 participants (actual)
Lead sponsor: Institut Straumann AGIndustry (pharma, biotech, devices)
Study start: 9 Oct 2019 (actual)
Primary completion: 9 Mar 2023 (actual)
Study completion: 23 Jun 2023 (actual)
First posted: 9 Nov 2018 (actual)
Results: Posted 12 Jun 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
SLActive® implant	Experimental	Device: SLActive® implant
SLA® implant	Active comparator	Device: SLA® implant

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (12 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SLActive® implantOne 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.	Device	SLActive® implant
SLA® implantOne 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.	Device	SLA® implant

Primary outcome

Bone Level Change 12 Months After Implant Loading
Time frame: 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).
Occurrence of Adverse Device Effects and Device Deficiencies That Could Have Led to a Serious Adverse Device Effect
Time frame: 12 months after implant loading
Occurrence of adverse device effects and device deficiencies that could have led to a serious adverse device effect

3 secondary outcomes

Change in Inflammatory and Anti-inflammatory Biomarkers Concentrations
Time frame: At implant placement, 1 and 4 weeks after implant placement
Change in Osseointegration Biomarkers Concentrations
Time frame: 1, 2, 4 and 8 weeks after implant placement
Implant Survival
Time frame: 12 months after implant loading

Results and safety

Results posted to the registry on 12 Jun 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
SLActive® Implant	68	61
SLA® Implant	68	61

Primary outcome: Bone Level Change 12 Months After Implant Loading

Time frame: 12 months after implant loading. Mean (Standard Deviation). Unit: mm

Measure	SLActive® Implant n = 55	SLA® Implant n = 55
Value	0.214 (0.391)	0.056 (0.093)

SLActive® Implant vs SLA® Implant: paired difference: 0.01, p = 0.074, t-test, 1 sided

Population analysed: Per protocol Population: defined as each eligible study subject with one study control and one study test implant and who performed all follow-up visits.

Primary outcome: Occurrence of Adverse Device Effects and Device Deficiencies That Could Have Led to a Serious Adverse Device Effect

Time frame: 12 months after implant loading. Number. Unit: events

Measure	SLActive® Implant n = 68	SLA® Implant n = 68
Number of ADE	14	20
Number of DD	0	0

Population analysed: The SAF populations defined as all patients who were enrolled in the study and who received a study device

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 12 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
SLActive® Implant	2 of 68 (2.9%)	26 of 68 (38.2%)	0 of 68
SLA® Implant	2 of 68 (2.9%)	26 of 68 (38.2%)	0 of 68

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Partially Edentulous Patients

Active, not recruiting
Non-Guided vs. Guided Surgery to Immediately Loaded PrimeTaper Implants in Partially Edentulous Patients
Partially Edentulous Maxilla or Mandible
Not yet recruiting
Evaluation of Occlusal Contact Distribution in Digitally Fabricated Implant-Retained Fixed Partial Dentures in Mandibular Kennedy Class II Patients Following Artificial Intelligence Bite Optimization: A Quasi-Experimental Study
Partially Edentulous Mandible
Active, not recruitingObservational study
Masticatory Efficiency, Bite Force, and Patient-Reported Outcomes in Patients Rehabilitated With Complete and Partial Dentures Supported by Teeth, Mini-Implants, or Conventional Implants
Edentulism, Edentulism Complete
Recruiting
Clinical Safety and Effectiveness of the Straumann Dynamic Navigation System Falcon
Partially Edentulous Jaw, Tooth Loss
Active, not recruiting
Esthetic and Radiographic Outcomes Following Immediate Implant Placement With Thin or Dehiscence Buccal Bone Wall
Jaw, Edentulous, Partially, Acquired Absence of Single Tooth

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mariano Sanz, Prof. Dr. principal investigator

Professor and Chairman of Periodontology

Juan Blanco-Carrión, Prof. Dr. principal investigator

Professor in Periodontology

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing SLActive® implant and SLA® implant in people with Partially Edentulous Patients, run by Institut Straumann AG at 2 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Bone Level Change 12 Months After Implant Loading (time frame: 12 months after implant loading). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03737357.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2025.