Correlation Between Peri-implantitis and Assumptions of Medications

NCT04783974 | Completed

• 1 other identifier: SC-AA-2
• Study Type: observational
• Target: 270
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Peri-Implantitis

Outcome Measures

Primary Outcomes (1)

• Risk of peri-implantitis

  Hazard risk of incurring in peri-implantitis in subjects assuming systemic medications (SSRIs, PPIs, anti-inflammatory drugs, and anti-hypertensive drugs)

  0 to 15 years

Secondary Outcomes (3)

• Influence of drugs on implant survival curves and peri-implantitis

  0 to 15 years

• Dosage and peri-implantitis

  0 to 15 years

• Dosage and implant failure

  0 to 15 years

Study Arms (5)

Patients assuming SSRI

Patients treated with dental implants and assuming selective serotonin reuptake inhibitors

Device: Dental implants

Patients assuming PPI

Patients treated with dental implants and assuming proton pump blockers

Device: Dental implants

Patients assuming Anti-inflammatory drugs

Patients treated with dental implants and assuming anti-inflammatory drugs

Device: Dental implants

Patients assuming Anti-hypertensive drugs

Patients treated with dental implants and assuming anti-hypertensive drugs

Device: Dental implants

Control group - Patients not assuming the studied drugs

Patients treated with dental implants and not assuming any of the following drugs: selective serotonin reuptake inhibitors, proton pump blockers, anti-inflammatory drugs, anti-hypertensive drugs

Device: Dental implants

Interventions

Dental implants DEVICE

Treatment of total or partial edentulism through the placement of osseointegrated dental implants

Control group - Patients not assuming the studied drugs; Patients assuming Anti-hypertensive drugs; Patients assuming Anti-inflammatory drugs; Patients assuming PPI; Patients assuming SSRI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The clinical records of all subjects treated with implants during the period between January 1st, 2005, and June 30th, 2020 in the Dental Clinic of the IRCCS Istituto Ortopedico Galeazzi (Milan, Italy) will be screened for inclusion

You may qualify if:

• subjects who were 18 years old or older at the time of intervention
• subjects who provided their informed consent for the intervention
• patients with total or partial edentulism treated with dental implants
• patients with at least 6 months follow-up, beginning from the date of placement of the prosthesis.

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

IRCCS Istituto Ortopedico Galeazzi

Milan, Italy

Location

Related Publications (18)

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MeSH Terms

Conditions

Peri-Implantitis

Interventions

Dental Implants

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental Materials; Biomedical and Dental Materials; Dental Prosthesis; Prosthodontics; Dentistry; Prostheses and Implants; Equipment and Supplies; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

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

Study Record Dates

• First Submitted: March 2, 2021
• First Posted: March 5, 2021
• Study Start: February 15, 2021
• Primary Completion: June 20, 2021
• Study Completion: June 20, 2021
• Last Updated: May 17, 2022

Record last verified: 2021-07

Locations

IT (1)