Peri-Implantitis Clinical Trial
Official title:
Association Between Smoking Habit and Peri-implant Diseases: a Case Control Study
Verified date | October 2022 |
Source | Universitat Internacional de Catalunya |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Although smoking has been proposed as well, as a risk factor/indicator for peri-implantitis, there is currently no conclusive evidence. The current literature confronts the inconclusive evidence of tobacco for a risk factor. Therefore, the aim of the present investigation is to determine the association between tobacco and peri-implantitis in sample of patients who had received therapy implant-supported restorative therapy in a university setting. The present study was designed as a retrospective case control study in a sample of patients with implant-supported restorative therapy 7-19 years after restorative phase. The study was conducted at the Clinica Universitaria d'Odontologia (CUO) in the Universitat Internacional de Catalunya (UIC) for 1 month and was performed following the principles outlined in the Declaration of Helsinki (revised, amended, and clarified in 2013. Prior to enrol the study a written informed consent was signed. Patients provided with implant-supported restorative therapy between 2001-2013 was selected from the UIC database. The sample was divided in three groups: healthy patients, patients with mucositis and patients with peri-implantitis. During the examination, the clinician reviewed with the patient the Information and Medication History Forms and record the anthropometric, socio-demographic and clinical information. An initial questionnaire was conducted to obtain information regarding age, gender, medical history, medication, and health behaviour. Candidates underwent an oral pathology examination and a full-mouth probing using a standardize pressure (20N) probe SONDA PA_ON (Orange Dental®, Aspachstr, Biberach, Germany) to determine their periodontal and peri-implant status. All statistical analyses were performed with the package RStudio (V2.5). Descriptive characteristics regarding all the covariates were summarized. Periimplant bone loss (95% Confidence Interval - 95% CI) were calculated both at implant- and at patient-level. A multilevel regression model will be applied to evaluate the influence of some risk/protective indicators on the risk for peri-implant bone loss. Risk/protective indicators for periimplantitis will be studied using multilevel (mixed-effects) multivariate regression analyses (patient- and implant-level). Each potential indicator was tested individually by adding it to an empty model having as dependent variable the peri-implant status and testing the significance.
Status | Completed |
Enrollment | 117 |
Est. completion date | June 30, 2021 |
Est. primary completion date | February 22, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. men and women over 18 years old, 2. partially or totally edentulous patients with at least one implant placed at the university and loaded 7-19 years before, 3. cemented, screwed or mechanically retained prosthesis, 4. single, partial prostheses, and complete (fixed and removable), 5. patients diagnose of peri-implant health and peri-implantitis and 6. ability to understand study procedures. Exclusion Criteria: Some patient that does not follow the inclusion criteria |
Country | Name | City | State |
---|---|---|---|
Spain | Josep Martínez | Sant Cugat Del Vallès | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Universitat Internacional de Catalunya |
Spain,
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* Note: There are 22 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Predictive value of smoking habit on peri-implant diseases | To determine the predictive value of tobacco and periimplantitis in a group of patients treated with implant therapy from 2001 to 2013 in Clinica Universitària d'Odotntologia de la Universitat Internacional de Catalunya. | 1 day | |
Secondary | Association between tobacco and peri-implant disease | To determine the association between tobacco and peri-implant diseases in patients with implant therapy (2001-2013) | 1 day |
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