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NCT04783974
Correlation Between Peri-implantitis and Assumptions of Medications
trial testing Dental implants in Peri-Implantitis in 270 participants. Completed in 20 June 2021.
20 June 2021
Quick facts
| Lead sponsor | I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 270 |
| Start date | 15 February 2021 |
| Primary completion | 20 June 2021 |
| Estimated completion | 20 June 2021 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- Dental implants
Conditions studied
- Peri-Implantitis — all drugs for Peri-Implantitis →
Sponsor
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio — full company profile →
Who can join
18 and older, any sex, with Peri-Implantitis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The aim of the study is to investigate the correlation between the assumption of systemic medications (such as SSRI, PPI, anti-inflammatory drugs and anti-hypertensive drugs) and the failure of dental implant therapy in terms of occurrence peri-implantitis and/or implant failure. The clinical records of all subjects treated with dental implants during the period between January 1st, 2005, and December 31st, 2020 in the Dental Clinic of the IRCCS Istituto Ortopedico Galeazzi (Milan, Italy) will be screened for inclusion. Inclusion criteria: i) subjects who were 18 years old or older at the time of intervention; ii) subjects who provided their informed consent for the intervention iii) patients with total or partial edentulism treated with dental implants; iv) patients with at least 6 months follow-up, beginning from the date of placement of the prosthesis. Exclusion criteria: i) incomplete data (e.g. absence of periapical radiographs) Descriptive statistics will be provided by means of mean values and standard deviations. Correlation between baseline parameters and outcomes will be provided through logistic regression. Survival tables and Kaplan-Meier analysis will be elaborated for survival analysis, considering the occurrence of implant failure and the diagnosis of peri-implantitis as events. Cox regression analysis will be used in order to evaluate the influence of the use of each drug on survival curves. The level of significance was set at p\<0.05. The sample size was calculated in order to evaluate the hazard risk of patients exposed to each specific drug (SSRI, PPI, Anti-inflammatory drugs or anti-hypertensive) compared to non-exposed patients. The ratio of exposed/non-exposed patients is expected to be 1:4 in the cohort. On the basis of a hypothesized 5-year incidence of peri-implantitis of 0.16, HR = 2, and a 10% dropout rate, the sample should be made of 358 subjects (72 exposed + 286 not exposed).
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04783974
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- ASCO Meeting Library
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Related trials
Other trials of Dental implants
Trials testing the same drug.
- NCT04960605 — Prognosis of Dental Implants in Patients With Primary Sjögren's Syndrome · NA · completed
- NCT06623968 — A 39-year Follow-up Study on the World´s First Single Dental Implants · completed
Other recruiting trials for Peri-Implantitis
Currently open trials in the same condition.
- NCT07012915 — Immunological-Clinical Evaluation of the Etiopathogenesis of Peri-Implantitis · NA · recruiting
- NCT06679283 — Surgical Treatment of Peri-implantitis With Adjunctive Application of Platelet Rich Fibrin (PRF) · NA · recruiting
- NCT06017817 — Antibacterial Photodynamic Therapy in the Management of Peri-implantitis · NA · recruiting
- NCT06364982 — Distance Between Dental Implants as a Risk Indicator for Peri-implant Disease. · recruiting
- NCT06288919 — Erythritol vs Ultrasonic Scaler Prophylaxis Systems on Dental Implants With Crowns Made by Different Materials · NA · active not recruiting
Other I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio trials
Trials by the same sponsor.
- NCT07386405 — Validation and Cultural Adaptation of the KOOS-ACL Scale for the Italian Population · not yet recruiting
- NCT07352111 — High-risk Coronary Atherosclerosis in Subjects With Family History of Myocardial Infarction · NA · recruiting
- NCT07304323 — Prepare II - Predictive Model Training and External Validation · recruiting
- NCT07337499 — Comparison of Maglumi X3 SNIBE With Other Analytical Methods in Laboratory Medicine for 25-(OH)D Quantification · recruiting
- NCT06940245 — Use of Virtual Reality for the Assessment of Attentional and Reaction Abilities for Fall Risk Evaluation · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04783974 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- Last refreshed: 17 May 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04783974.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing