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The Influence of Implant Position on the Occurrence of Biological Complications

NCT05358782 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 130

Last updated 2022-05-09

No results posted yet for this study

Summary

The primary objective of this study will be to study the correlation between implant position (malposition), evaluated through periapical radiographs of peri-implantitis vs healthy implants, and the occurrence of peri-implant biological complications such as peri-implantitis, as evaluated after at least 6 months from the placement of the prosthesis. The clinical records of all subjects treated with implants during the period between January 1st, 2005, and June 30th, 2021 (last follow-up included: 6 month visit on December 2021) in the Dental Clinic of the IRCCS Istituto Ortopedico Galeazzi (Milan, Italy) will be screened for inclusion.

Will be included 45 implants with peri-implantitis and 135 healthy implants regardless of the corresponding number of patients . Descriptive statistics will be provided by means of mean values and standard deviations. Correlation between baseline parameters and outcomes will be measured through regression analysis, being the independent variable the occurrence of peri-implantitis. Multilevel analysis will be performed.

For all the analysis, the level of significance was set at p\<0.05.

For sample size calculation the investigators have considered alpha = .05, power = 80% and a proportion between controls and cases of 3:1. The investigators hypothesized a detection of an effect of malposition with a proportion of 0.25 of exposes in control group and 0.5 in test group. the investigators decided to include 45 implants with peri-implantitis and 135 healthy implants, after augmenting the numbers hypothesizing a maximum of 10% dropouts. The proportion of exposed are estimated on the basis of the study published by Yi et al. in 2020 .

The calculation was performed using the method proposed by Schoenfeld.

Conditions

  • Peri-Implantitis

Interventions

DEVICE

Dental implant positioning

observational study of the effect of implant malposition

Sponsors & Collaborators

  • I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-06
Primary Completion
2022-10-06
Completion
2023-02-06

Countries

  • Italy

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 NCT05358782 on ClinicalTrials.gov