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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.
The primary outcome was the occurrence of peri-implantitis described as:
Implant malposition will be defined on the basis of the following parameters:
The following parameters will be collected from clinical records:
Clinical data will be completely anonymized through the association of each subject to one identification code, and the elimination of the document containing the link between them.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Implant with peri-implantitis | Implant with progressive marginal bone loss |
| |
| Healthy implant | Implant without any sign of marginal bone loss |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dental implant positioning | Device | observational study of the effect of implant malposition |
|
| Measure | Description | Time Frame |
|---|---|---|
| occurence of peri-implantitis | 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 | 198 months |
| Measure | Description | Time Frame |
|---|---|---|
| occurence of peri-implantitis independently from smoking/periodontitis | assess how implant position is related to the occurrence of peri-implantitis, independently from the exposure to smoking or to periodontitis | 198 months |
| operator's experience |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stefano Corbella, PhD, Researcher | Contact | 3386842640 | stefano.corbella@gmail.com | |
| benedetta morandi | Contact | 3331224460 | benedettamorandi89@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Istituto Ortopedico Galeazzi | Recruiting | Milan | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Quality assessment of radiographs. 2018. London: FGDP(UK); [accessed]. https://www.fgdp.org.uk/SiD/a2-quality-assessment-radiographs. | ||
| 31107993 | Background | Arunyanak SP, Sophon N, Tangsathian T, Supanimitkul K, Suwanwichit T, Kungsadalpipob K. The effect of factors related to periodontal status toward peri-implantitis. Clin Oral Implants Res. 2019 Aug;30(8):791-799. doi: 10.1111/clr.13461. Epub 2019 Jun 12. | |
| 29926491 |
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| ID | Term |
|---|---|
| D057873 | Peri-Implantitis |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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the influence of operator's experience on the odds of development of peri-implantitis
| 198 months |
| implant-tooth and implant-implant distance | - the occurrence of peri-implantitis as related to absolute values of implant-tooth and implant-implant distance | 198 months |
| characteristics of the prosthesis | - the occurrence of peri-implantitis as related to characteristics of the prosthesis (emergency profile, cantilevers, imprecise implant-abutment connection) | 198 months |
| Background |
| Berglundh T, Armitage G, Araujo MG, Avila-Ortiz G, Blanco J, Camargo PM, Chen S, Cochran D, Derks J, Figuero E, Hammerle CHF, Heitz-Mayfield LJA, Huynh-Ba G, Iacono V, Koo KT, Lambert F, McCauley L, Quirynen M, Renvert S, Salvi GE, Schwarz F, Tarnow D, Tomasi C, Wang HL, Zitzmann N. Peri-implant diseases and conditions: Consensus report of workgroup 4 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. J Clin Periodontol. 2018 Jun;45 Suppl 20:S286-S291. doi: 10.1111/jcpe.12957. |
| 15635945 | Background | Buser D, Martin W, Belser UC. Optimizing esthetics for implant restorations in the anterior maxilla: anatomic and surgical considerations. Int J Oral Maxillofac Implants. 2004;19 Suppl:43-61. |
| 26584716 | Background | Canullo L, Tallarico M, Radovanovic S, Delibasic B, Covani U, Rakic M. Distinguishing predictive profiles for patient-based risk assessment and diagnostics of plaque induced, surgically and prosthetically triggered peri-implantitis. Clin Oral Implants Res. 2016 Oct;27(10):1243-1250. doi: 10.1111/clr.12738. Epub 2015 Nov 20. |
| 30391683 | Background | Ferreira SD, Martins CC, Amaral SA, Vieira TR, Albuquerque BN, Cota LOM, Esteves Lima RP, Costa FO. Periodontitis as a risk factor for peri-implantitis: Systematic review and meta-analysis of observational studies. J Dent. 2018 Dec;79:1-10. doi: 10.1016/j.jdent.2018.09.010. Epub 2018 Nov 2. |
| 30702771 | Background | Francetti L, Cavalli N, Taschieri S, Corbella S. Ten years follow-up retrospective study on implant survival rates and prevalence of peri-implantitis in implant-supported full-arch rehabilitations. Clin Oral Implants Res. 2019 Mar;30(3):252-260. doi: 10.1111/clr.13411. Epub 2019 Feb 18. |
| Background | Lekholm U, Zarb GA. 1985. Patient selection and preparation. In: Branemark PI, Zarb GA, Albrektsson T, editors. Tissue-integrated prostheses: Osseointegration in clinical dentistry. Chicago: Quintessence. p. 199-209. |
| 26701350 | Background | Monje A, Aranda L, Diaz KT, Alarcon MA, Bagramian RA, Wang HL, Catena A. Impact of Maintenance Therapy for the Prevention of Peri-implant Diseases: A Systematic Review and Meta-analysis. J Dent Res. 2016 Apr;95(4):372-9. doi: 10.1177/0022034515622432. Epub 2015 Dec 23. |
| 6354290 | Background | Schoenfeld DA. Sample-size formula for the proportional-hazards regression model. Biometrics. 1983 Jun;39(2):499-503. |
| 31912511 | Background | Yi Y, Koo KT, Schwarz F, Ben Amara H, Heo SJ. Association of prosthetic features and peri-implantitis: A cross-sectional study. J Clin Periodontol. 2020 Mar;47(3):392-403. doi: 10.1111/jcpe.13251. Epub 2020 Jan 21. |