Association Between Smoking Habit and Peri-implant Diseases: a Case Control Study
NCT04952428 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 117
Last updated 2022-10-24
Summary
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.
Conditions
- Peri-Implantitis
- Peri-implant Mucositis
- Bone Loss, Alveolar
Interventions
- BEHAVIORAL
-
Re-examination visit ("today visit")
Re-examination visit ("today visit") A guidebook will be prepared to standardize procedures throughout the protocol, step by step, for all questionnaires and evidence collection. The data will be transferred to a computerized database. The clinician will review with the patient the Information and Medication History Forms and record the anthropometric, socio-demographic and clinical information. Candidates will undergo an oral pathology examination and a full-mouth manual probing using a periodontal probe SONDA PA\_ON (Orange Dental®, Aspachstr, Biberach, Germany) to determine their periodontal and peri-implant status. Clinical and radiographic examination will be performed. Moreover, signs as presence of suppuration, bleeding, redness, probing depth must be recorded at 6 sites per implant applying. As well, a specific survey about tobacco habits including modification of Fagestrom \& Richmond test will be conducted.
Sponsors & Collaborators
-
Universitat Internacional de Catalunya
lead OTHER
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2021-02-15
- Primary Completion
- 2021-02-22
- Completion
- 2021-06-30
Countries
- Spain
Study Locations
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