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Dental Implants With a SLActive® vs. SLA® Surface

Primary Purpose

Partially Edentulous Patients

Status

Active

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

SLActive® implant

SLA® implant

About this trial

This is an interventional treatment trial for Partially Edentulous Patients focused on measuring dental implants, SLActive® surface, biomarkers, BLT implant

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Universidad Complutense
Universidad de Santiago de Compostela

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SLActive® implant

SLA® implant

Arm Description

Outcomes

Primary Outcome Measures

Bone Level Change

Bone level change at 12 months after implant loading

Occurrence of adverse device effects and device deficiencies that could have led to a serious adverse device effect

Secondary Outcome Measures

Bone Level Change

Bone Level Change 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.

Change in osseointegration biomarkers concentrations

Change in osseointegration biomarkers ( VEGF, osteocalcin (OCN), osteopontin (OPN)) concentrations in gingival crevicular fluid samples.

Implant survival

Implant survival at 12 months after implant loading

Full Information

NCT ID

NCT03737357

First Posted

October 25, 2018

Last Updated

March 29, 2023

Sponsor

Institut Straumann AG

1. Study Identification

Unique Protocol Identification Number

NCT03737357

Brief Title

Dental Implants With a SLActive® vs. SLA® Surface

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

October 9, 2019 (Actual)

Primary Completion Date

March 9, 2023 (Actual)

Study Completion Date

June 23, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Institut Straumann AG

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Partially Edentulous Patients

Keywords

dental implants, SLActive® surface, biomarkers, BLT implant

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

SLActive® implant

Arm Type

Experimental

Arm Title

SLA® implant

Arm Type

Active Comparator

Intervention Type

Device

Intervention Name(s)

SLActive® implant

Intervention Description

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

Intervention Name(s)

SLA® implant

Intervention Description

Primary Outcome Measure Information:

Title

Bone Level Change

Description

Bone level change at 12 months after implant loading

Time Frame

12 months after implant loading

Title

Occurrence of adverse device effects and device deficiencies that could have led to a serious adverse device effect

Description

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

Secondary Outcome Measure Information:

Title

Bone Level Change

Description

Bone Level Change between implant placement and loading and between loading and 12 months after implant loading

Time Frame

between implant placement and loading and between loading and 12 months after implant loading

Title

Change in inflammatory and anti-inflammatory biomarkers concentrations

Description

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.

Time Frame

30 days after implant placement

Title

Change in osseointegration biomarkers concentrations

Description

Change in osseointegration biomarkers ( VEGF, osteocalcin (OCN), osteopontin (OPN)) concentrations in gingival crevicular fluid samples.

Time Frame

between day 7 and 8 weeks after implant placement

Title

Implant survival

Description

Implant survival at 12 months after implant loading

Time Frame

12 months after implant loading

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mariano Sanz, Prof. Dr.

Organizational Affiliation

Professor and Chairman of Periodontology

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Juan Blanco-Carrión, Prof. Dr.

Organizational Affiliation

Professor in Periodontology

Official's Role

Principal Investigator

Facility Information:

Facility Name

Universidad Complutense

City

Madrid

Country

Spain

Facility Name

Universidad de Santiago de Compostela

City

Santiago De Compostela

Country

Spain

12. IPD Sharing Statement

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Dental Implants With a SLActive® vs. SLA® Surface

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