Results of a New Fully Tapered Implant at One Year

NCT05187143 | Completed DMC FDA Device

• 1 other identifier: SC_BLX_US19
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Bone level changes

  To assess changes in interproximal bone levels, standardized periapical radiographs were taken of the treated areas.

  One year

Interventions

DENTAL IMPLANT DEVICE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A total of 30 patients (30 implants) were included (19 male and 11 female). All patients completed the follow-up at one year. All patients had periodontal health. Implants were placed in 22 non-smoking patients and 8 light smokers. At the time of surgery, there were no complications in any patient.

You may qualify if:

• 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.

Sponsors & Collaborators

• University of Santiago de Compostela: lead
• Institut Straumann AG: collaborator

Study Sites (1)

Master Periodoncia

Santiago de Compostela, 15782, Spain

Location

MeSH Terms

Interventions

Dental Implants

Intervention Hierarchy (Ancestors)

Dental Materials; Biomedical and Dental Materials; Dental Prosthesis; Prosthodontics; Dentistry; Prostheses and Implants; Equipment and Supplies; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: 1. Periodontology Unit, School of Medicine and Dentistry, University of Santiago de Compostela, Spain.

Study Record Dates

• First Submitted: December 23, 2021
• First Posted: January 11, 2022
• Study Start: June 1, 2019
• Primary Completion: July 31, 2020
• Study Completion: July 31, 2020
• Last Updated: January 11, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)