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Results of a New Fully Tapered Implant at One Year

Clinical and Radiographic Outcomes of a New Fully Tapered Implant With the One-time One-abutment Approach: In-line Clinical Case Series With 1-year Follow-up

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05187143
Enrollment
30
Registered
2022-01-11
Start date
2019-06-01
Completion date
2020-07-31
Last updated
2022-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Implant Site Reaction

Keywords

Fully tapered implants, platform switching, one-time one-abutment, crestal bone loss.

Brief summary

Objective: The aim of this prospective observational clinical study is to evaluate the bone level changes in a new implant design, fully tapered and platform switching with the one-time one-abutment protocol after one year of loading. Material and methods: Thirty patients received 1 or 2 implants (6, 8 and 10 mm in length, 3.5, 3.75 or 4.5 mm diameter and bone level design) to replace a single or multiple gap. Radiographic, clinical, esthetic and survival success rate were evaluated after one year of loading. Results: At 12 months post final loading, there were no peri-implant bone loss in any of the cases. Mean marginal crestal bone loss between surgery and crown placement was 0.19 ± 0.17 (p \<0.0001). Between surgery and 12 months of follow-up, the mean marginal crestal bone loss was 0.25 ± 0.24 (p \<0.0001). There were a SSD between 1 year follow-up and crown placement in PI in the mesial (0.33 ± 0.54 p= 0.003) and distal aspect (0.5 ± 0.73 p= 0.001). The PPD was SSD deeper at 1 year follow-up than at crown placement only in the mesial and distal probing (averaged depth=0.75 and p\<0.0005). No statistically significant differences were found for any of the other clinical and est

Interventions

DEVICEDENTAL IMPLANT

The study implants were 3.5, 3.75 or 4.5 mm implant diameter, Straumann® BLX implant SLActive® Roxolid® (Institut Straumann AG, Basel, Switzerland) and the abutment was a 0 °, 2.5 mm of height Straumann® Screw-retained Abutment. The length of the implants was 6, 8 and 10 mm. The 6 mm implant is only commercially available in 3.75 and 4.5 diameter.

Sponsors

Institut Straumann AG
CollaboratorINDUSTRY
University of Santiago de Compostela
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Males or females with, at least 18 years old. * Single and multiple gaps (premolars & molars) that require single and partial fixed restorations (2 implants, 1 pontic). * Adequate bone quantity at the implant site to allow the placement of diameter 3.5, 3.75 or 4.5 mm and lengths of 6 mm, 8 mm, 10 mm, 12 mm or 14 mm. * Patients had to be informed of the follow up visits and willing to attend to the clinical centre for these appointments.

Exclusion criteria

As systemic

Design outcomes

Primary

MeasureTime frameDescription
Bone level changesOne yearTo assess changes in interproximal bone levels, standardized periapical radiographs were taken of the treated areas.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026