Dental Implants With a SLActive® vs. SLA® Surface

Partially Edentulous Patients Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03737357
• Other study ID #: CR 2017-05
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 9, 2019
• Est. completion date: June 23, 2023

Study information

• Verified date: October 2022
• Source: Institut Straumann AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: June 23, 2023
• Est. primary completion date: March 9, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Mouth, Edentulous
• Partially Edentulous Patients

Intervention

Device:
• 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.
• 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.

Locations

Country	Name	City	State
Spain	Universidad Complutense	Madrid
Spain	Universidad de Santiago de Compostela	Santiago De Compostela

Sponsors (1)

Lead Sponsor	Collaborator
Institut Straumann AG

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone Level Change	Bone level change at 12 months after implant loading	12 months after implant loading
Primary	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	Bone Level Change	Bone Level Change between implant placement and loading and between loading and 12 months after implant loading	between implant placement and loading and between loading and 12 months after implant loading
Secondary	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.	30 days after implant placement
Secondary	Change in osseointegration biomarkers concentrations	Change in osseointegration biomarkers ( VEGF, osteocalcin (OCN), osteopontin (OPN)) concentrations in gingival crevicular fluid samples.	between day 7 and 8 weeks after implant placement
Secondary	Implant survival	Implant survival at 12 months after implant loading	12 months after implant loading