An interventional study of Ceramic Dental Implant and Titanium Dental Implant in Dental Implants, Single-Tooth, sponsored by Institut Straumann AG. Completed at 3 sites in 3 countries. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-23.
Sponsored by Institut Straumann AG · Not applicable, Interventional, and Treatment
A post-market, multi-centre, prospective, open, randomized-controlled, non-inferiority clinical study to compare short-term performance and safety of the Straumann PURE 2-piece Ceramic Implant with Straumann Bone Level Implant using a fully digital workflow.
To compare short-term performance and safety of the Straumann PURE 2-piece Ceramic Implant with Straumann Bone Level Implant using a fully digital workflow. Post-market, multi-centre, prospective, open, randomized-controlled, non-inferiority clinical study investigating patients in need of dental implant therapy for single-tooth gap rehabilitation. The follow up time is1 year after final crown restoration.
Institut Straumann AG is the lead sponsor of 28 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with healed extraction sockets, which means that at implant surgery:
Exclusion Criteria:
Furthermore, patients with uncontrolled periodontitis and less than 3 mm of keratinized mucosa at the day of surgery will be excluded from the study. Controlled periodontitis is defined as treated periodontitis with two or less pockets that are \< 4 mm in depth or the existence of ≤ 20% bleeding on probing.
If the planned implant position is the second premolar, the adjacent molar must be present. Shortened arches with missing molars are not eligible in such a case.
Receive new zirconia implant: Straumann® PURE 2-piece Ceramic Implant (tissue level), ZLA
Device: Ceramic Dental Implant
Receive standard titanium implant: Straumann® Bone Level Implant, Titanium, SLA
Device: Titanium Dental Implant
The ceramic implant will be placed in healed extraction sockets in the premolar-to-premolar area in the mandible and maxilla for single tooth replacement followed by prosthetic loading after 4 months healing time. Type 4 surgery will be performed as defined by the ITI Consensus Statements for Implant Placement in Extraction Sockets: healed sites, typically around 16 weeks after tooth was extracted or after tooth was lost to allow complete healing of the ridge as well as soft- and hard tissue maturation. Both SG and CG receive routine treatment, only the choice of the implant material is defined by the study protocol.
The titanium implant will be placed in healed extraction sockets in the premolar-to-premolar area in the mandible and maxilla for single tooth replacement followed by prosthetic loading after 4 months healing time. Type 4 surgery will be performed as defined by the ITI Consensus Statements for Implant Placement in Extraction Sockets: healed sites, typically around 16 weeks after tooth was extracted or after tooth was lost to allow complete healing of the ridge as well as soft- and hard tissue maturation. Both SG and CG receive routine treatment, only the choice of the implant material is defined by the study protocol.
Bone Level Change
Change in crestal bone level measured by analysis of standardized peri-apical xrays 12 months after loading \[mm\].
Time frame: 12 months after implant loading (final crown restoration)
Implant survival
Implant survival rates 3, 6 months and 1 year after loading: yes/no
Time frame: 12 months after loading.
14 item Oral Health Impact Profile (OHIP-14)
The local language version of the OPHIP-14 is a self-reported questionnaire that measures dysfunction, discomfort and disability attributed to oral conditions. The questionnaire focuses on seven dimensions of impact: Functional limitation; Pain; Psychological discomfort; Physical disability; Psychological disability; Social disability; Handicap. The patients will be asked to respond according to frequency of impact on a 5-point Likert scale coded never (score 0), hardly ever (score 1), occasionally (score 2), fairly often (score 3) and very often (score 4).
Time frame: 12 months after loading.
Adverse Events
Adverse Events will be recorded at every visit.
Time frame: 18 months after inclusion.
Device Deficiencies
Any device complications and deficiencies will be recorded as Device Deficiencies.
Time frame: 18 months after inclusion.
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Institut Straumann AG