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

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

Study Overview

• Status: Completed
• Conditions: Implant Site Reaction
• Intervention / Treatment: Device: DENTAL IMPLANT

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• Spain
  • Santiago De Compostela, Spain, 15782
    • Master Periodoncia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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 exclusion criteria, patients with systemic diseases that could interfere with dental implant therapy, smokers of more than 10 cigarettes per day, alcoholism or drug abuse, physical or mental disabilities, pregnant or lactating women and/or conditions or circumstances, in the opinion of the investigator, that could prevent the completion of the participation in the study or interfering with the analysis of study results (non-compliance).

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bone level changes	To assess changes in interproximal bone levels, standardized periapical radiographs were taken of the treated areas.	One year

Collaborators and Investigators

• Sponsor: University of Santiago de Compostela
• Collaborators: Institut Straumann AG

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2019
• Primary Completion (Actual): July 31, 2020
• Study Completion (Actual): July 31, 2020

Study Registration Dates

• First Submitted: December 23, 2021
• First Submitted That Met QC Criteria: January 10, 2022
• First Posted (Actual): January 11, 2022

Study Record Updates

• Last Update Posted (Actual): January 11, 2022
• Last Update Submitted That Met QC Criteria: January 10, 2022
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Fully tapered implants, platform switching, one-time one-abutment, crestal bone loss.
• Other Study ID Numbers: SC_BLX_US19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No