Results of a New Fully Tapered Implant at One Year

NCT ID: NCT05187143

Last Updated: 2022-01-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-06-01
• Study Completion Date: 2020-07-31

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

Conditions

Implant Site Reaction

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

The presence of one of the following circumstances was considered a local exclusion criterion: patients with inadequate oral hygiene (plaque control > 25%) (Mombelli et al., 1987), untreated endodontic lesions, any bone augmentation procedure before or during the implant placement, local inflammation (including untreated periodontitis), mucosal diseases such as erosive lichen planus, history of local irradiation therapy in the head-neck area and/or extraction sockets with less than 12 weeks of healing.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Institut Straumann AG

INDUSTRY

Sponsor Role: collaborator

University of Santiago de Compostela

OTHER

Sponsor Role: lead

Responsible Party

Juan Blanco Carrión

1. Periodontology Unit, School of Medicine and Dentistry, University of Santiago de Compostela, Spain.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Master Periodoncia

Santiago de Compostela, , Spain

Countries

Spain

Other Identifiers

SC_BLX_US19

Identifier Type: -

Identifier Source: org_study_id