CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 70 enrolled
Drug / intervention
SLActive® implant +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03737357
NCT03737357N/ACompleted
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A Randomized Controlled Study to Assess Intra-patient Clinical Performance of Dental Implants With a SLActive® vs. SLA® Surface

Institut Straumann AG·interventional·Posted Nov 9, 2018·Updated Jun 12, 2025

In Brief

A clinical study evaluating SLActive® implant and SLA® implant for Partially Edentulous Patients. Completed, enrolled 70 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPartially Edentulous Patients
CountriesSpain
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedNov 9, 2018
Enrollment StartOct 9, 2019
Primary CompletionMar 9, 2023
Study CompletionJun 23, 2023
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 7.6 years ago

Interventions

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.