NCT05358782

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
130

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 6, 2022

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

April 28, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 3, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 6, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 6, 2023

Completed
Last Updated

May 9, 2022

Status Verified

May 1, 2022

Enrollment Period

6 months

First QC Date

April 28, 2022

Last Update Submit

May 3, 2022

Conditions

Peri-Implantitis

Keywords

peri-implant lossdental radiographyimplant malposition

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (4)

  • occurence of peri-implantitis independently from smoking/periodontitis

    198 months

  • operator's experience

    198 months

  • implant-tooth and implant-implant distance

    198 months

  • characteristics of the prosthesis

    198 months

Study Arms (2)

Implant with peri-implantitis

Implant with progressive marginal bone loss

Device: Dental implant positioning

Healthy implant

Implant without any sign of marginal bone loss

Device: Dental implant positioning

Interventions

Dental implant positioningDEVICE

observational study of the effect of implant malposition

Healthy implantImplant with peri-implantitis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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.

You may qualify if:

  • 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.

You may not qualify if:

  • Incomplete data (e.g. absence of periapical radiographs).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Istituto Ortopedico Galeazzi

Milan, Italy

RECRUITING

Related Publications (11)

  • Quality assessment of radiographs. 2018. London: FGDP(UK); [accessed]. https://www.fgdp.org.uk/SiD/a2-quality-assessment-radiographs.

    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.

    PMID: 31107993BACKGROUND

  • 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.

    PMID: 29926491BACKGROUND

  • 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.

    PMID: 15635945BACKGROUND

  • 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.

    PMID: 26584716BACKGROUND

  • 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.

    PMID: 30391683BACKGROUND

  • 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.

    PMID: 30702771BACKGROUND

  • 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.

    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.

    PMID: 26701350BACKGROUND

  • Schoenfeld DA. Sample-size formula for the proportional-hazards regression model. Biometrics. 1983 Jun;39(2):499-503.

    PMID: 6354290BACKGROUND

  • 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.

    PMID: 31912511BACKGROUND

MeSH Terms

Conditions

Peri-Implantitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Central Study Contacts

Stefano Corbella, PhD, Researcher

CONTACT

3386842640stefano.corbella@gmail.com

benedetta morandi

CONTACT

3331224460benedettamorandi89@gmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2022

First Posted

May 3, 2022

Study Start

April 6, 2022

Primary Completion

October 6, 2022

Study Completion

February 6, 2023

Last Updated

May 9, 2022

Record last verified: 2022-05

Locations

IT(1)