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Results of a New Fully Tapered Implant at One Year

NCT05187143 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2022-01-11

No results posted yet for this study

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

Conditions

  • Implant Site Reaction

Interventions

DEVICE

DENTAL 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 & Collaborators

  • Institut Straumann AG

    collaborator INDUSTRY

  • University of Santiago de Compostela

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-06-01
Primary Completion
2020-07-31
Completion
2020-07-31
FDA Device
Yes

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05187143 on ClinicalTrials.gov