N/A
Completed N=53
Bone Level Tapered Multi-Center Study
Source: ClinicalTrials.gov NCT02569671 ↗Enrolled (actual)
53
Serious AEs
11.3%
Results posted
Jul 2025
Primary outcomePrimary: Mean Crestal Bone Level Change — 0.5; 0.5 Change in Mean crestal bone levels (mm) — p=.950
Summary
The aim of this randomized, controlled, multi-center study is to assess the clinical and radiographic outcomes of using a Straumann® Bone Level Tapered implant for immediate implantation following extraction of a tooth in the pre-molar and anterior region of the maxilla and mandible (test) compared to the outcomes of placing this implant in healed sites (control).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Crestal Bone Level Change |
0.5; 0.5 | .950 |
| SECONDARY Implant Success and Survival |
1; 2; 23; 23 | — |
| SECONDARY Buccal Bone Dimensional Changes |
2.1; 2.0; 2.1; 1.8 | 0.022 sig |
| SECONDARY Implant Measure as Measured by ISQ at Implant Surgery |
9; 0; 2; 2; 14; 23 | — |
| SECONDARY Implant Stability as Measured by ISQ at Implant Loading |
0; 1; 4; 3; 19; 20 | — |
| SECONDARY Implant Stability as Measured by ISQ at Final Restoration |
1; 1; 3; 1; 19; 22 | — |
| SECONDARY Change in Soft Tissue Measurements |
-0.3; 0.1; -0.2; 0.1; -0.4; -0.1 | — |
| SECONDARY Subject Satisfaction |
5.9; 14.7; 97.9; 97.8; 96.5; 96.3 | — |
| SECONDARY Number of Participants With Adverse Events and Adverse Device Effects Over 12 Months |
6; 12; 2; 4; 1; 2 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects must have voluntarily signed the informed consent form before any study related procedures
- Subjects must be males or females who are a minimum of 18 years of age
- Subjects who are in need of a single tooth extraction in the pre-molar or anterior region of the maxilla or mandible (ADA tooth positions 4-13 and 20-29) and replacement with a dental implant.
- Implants must be placed either immediately in an extraction socket or placed in a healed site (greater than 4 months healing) which has not been previously grafted.
- Planned site for implant must have a natural tooth both mesially and distally in the adjacent tooth positions
- Subjects must have opposing dentition (natural teeth, fixed or removable restorations)
- There must be sufficient bone at the implant site to achieve primary stability
- Subjects must be committed to the study and the required follow-up visits
- Subjects must be in good general health as assessed by the Investigator
Exclusion Criteria
- Subjects with a systemic disease that would preclude dental implant surgery
- Subjects with any contraindications for oral surgical procedures
- Subjects with mucosal diseases (e.g., erosive lichen planus) in the localized area around the study implant site
- Subjects with a history of local irradiation therapy in the head/neck area
- Subjects with any untreated endodontic lesions or untreated periodontal disease adjacent to the implant site
- Subjects receiving, or having a history of receiving, intravenous or subcutaneous antiresorptive agents, such as bisphosphonates
- Subjects with severe bruxing, parafunctional habits, or temporomandibular joint dysfunction
- Any implant sites where there will be a buccal dehiscence greater than 3 mm or there will be a fenestration of the implant
- Subjects with inadequate oral hygiene or who are unmotivated for adequate home care
- Subjects who have physical or mental handicaps that would interfere with the ability to perform adequate oral hygiene
- Subjects who are pregnant or intending to become pregnant during the duration of the study
- Subjects who are heavy smokers (defined as >10 cigarettes per day or >1 cigar per day) or chew tobacco
- Subjects who abuse alcohol or drugs
- Subjects who have undergone administration of any investigational device within 30 days of enrollment in the study
- Subjects with 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
Data sourced from ClinicalTrials.gov (NCT02569671). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.