Results of a New Fully Tapered Implant at One Year

Completed

• Conditions: Implant Site Reaction

• Registration Number: NCT05187143
• Lead Sponsor: University of Santiago de Compostela

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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-06-01
• Primary Completion: 2020-07-31
• Study Completion: 2020-07-31
• Status Verified: 2021-12
• Study First Submitted: 2021-12-23
• Study First Submitted QC: 2022-01-10
• Last Update Submitted: 2022-01-10
• Study First Posted: 2022-01-11
• Last Update Posted: 2022-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Bone level changes	One year	To assess changes in interproximal bone levels, standardized periapical radiographs were taken of the treated areas.

Trial Locations

Locations (1)

Master Periodoncia; 🇪🇸 Santiago De Compostela, Spain