The Influence of Implant Position on the Occurrence of Biological Complications (NCT05358782) | Clinical Trial Compass
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The Influence of Implant Position on the Occurrence of Biological Complications
Italy130 participantsStarted 2022-04-06
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* subjects aged more than 18 years old, treated with implants with moderately rough surface.
* subjects treated with dental implants at Istituto Ortopedico Galeazzi during the period between January 1st, 2005, and June 30th, 2021
* subjects without any systemic disease that could be an impact on bone metabolism (e.g. diabetes mellitus, osteoporosis, neoplasms)
* single and partial rehabilitations (without cantilever extension): single tooth restorations (one implant between two teeth or one single implant supporting single-tooth prosthesis with one adjacent tooth); multiple tooth restorations (one tooth per implant or bridges, splinted or not).
* complete information about patient status (systemic diseases, smoking status, medications, age, gender)
* complete description of the surgical and prosthetic protocol that was adopted.
* at least one periapical radiograph of good quality taken at the end of the intervention and a sufficient number of follow-up visits (at least one per year); the quality of the images will be assessed by the Guidance Notes for Dental Practitioners on the Safe Use of X-Ray Equipment ((UK) 2018), accepting Grade 1 and Grade 2 images.
* having clinical and / or radiographic records to assess periodontal status at the time of intervention.
Exclusion Criteria:
* Incomplete data (e.g. absence of periapical radiographs).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.