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临床试验/NCT04952428
NCT04952428已完成不适用

Association Between Smoking Habit and Peri-implant Diseases: a Case Control Study

Universitat Internacional de Catalunya1 个研究点 分布在 1 个国家目标入组 117 人开始时间: 2021年2月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
117
试验地点
1
主要终点
Predictive value of smoking habit on peri-implant diseases

研究概览

简要总结

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.

详细描述

  1. Introduction Nowadays, dental implants are a good restorative option for those patients who have lost one or more teeth in order to re-establish function and aesthetics. Nevertheless, dental implants are not free of suffering complications and disease. Peri-implant diseases are inflammatory conditions affecting the tissues surrounding the bone anchored implants, triggered by the presence of peri-implant biofilms in susceptible individuals (Rinke et al., 2011; Roos-Jansåker, Lindahl, et al., 2006; Roos-Jansåker, Renvert, et al., 2006; Schwarz et al., 2017)(Roos-Jansåker, Lindahl, et al., 2006; Roos-Jansåker, Renvert, et al., 2006; Schwarz et al., 2017)(Merli et al., 2014). At the New World Workshop in Periodontology (2017) these terms were revised and it was concluded that peri-implant mucositis is the presence of reversible inflammatory changes in the mucosa around an implant with no signs of loss of supporting bone, while peri-implantitis is the condition of inflammation of the peri-implant tissues involving loss of supporting bone (Renvert et al., 2018).

Peri-implant diseases are prevalent, and its presence has increased over time. As it is reported in the Swedish population, peri-implant mucositis appears in 32% of the patients, whereas peri-implantitis was observed in 45% of the patients (Derks et al., 2016). In addition, a cross-sectional study Spain revealed the presence of peri-implant mucositis in the 24% of patients, while peri-implantitis was found in the 18% (Rodrigo et al., 2018). For that high percentage of peri-implantitis, it seems reasonable to do a patient-specific risk assessment for implant therapy, and there is a clear need to identify an effective method to prevent peri-implant infections. According to the New World Workshop on Periodontology there is strong evidence that history of periodontitis, poor plaque control and lack of regular maintenance is a risk factor for peri-implantitis (Renvert et al., 2018).

Regarding tobacco, there is scientific evidence that affirms it is a risk factor for the periodontal disease progression and its effect on biofilm (Winkelhoff et al., 2001), host response (Palmer et al., 2005), wound healing and periodontal treatment success (Bunæs et al., 2015; Fisher et al., 2008; Kotsakis et al., 2015). It has been reported more presence of some periodontopathogens in smokers in comparison to non-smokers such as B forsythia, P micros, F nucleatum and C rectus; an effect on neutrophil's function, lymphocytes and on the vasculature of the periodontal tissues (Palmer et al., 2005) being more predisposed to periodontal breakdown and recurrence (Bunæs et al., 2015; Fisher et al., 2008; Kotsakis et al., 2015).

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. Studies by Schwarz, Roos-Jansaker or Rinke concluded that smoking habit has 2.7 to 31 times more probability to cause peri-implantitis with Odds Ratio (OR) ranging from 2.7 to 31.6 respectively (Rinke et al., 2011; Roos-Jansåker, Lindahl, et al., 2006; Roos-Jansåker, Renvert, et al., 2006; Schwarz et al., 2017)Furthermore, it has been reported by Karoussis and coworkers an incidence of peri-implant diseases of 6% in non-smokers vs 17,9% in smokers. The biologic processes involved in osseointegration and maintenance of peri-implant bone levels could be likely affected by tobacco smoking(Karoussis et al., 2003). However, most of the literature shows (Aguirre-Zorzano et al., 2015; ALHarthi et al., 2018; Canullo et al., 2016; Casado et al., 2013; Dalago et al., 2017; Daubert et al., 2015; de Araújo Nobre et al., 2015; Dvorak et al., 2011; Koldsland et al., 2010, 2011; Marrone et al., 2013; Máximo et al., 2008; Rokn et al., 2017) that there is no association between tobacco smoking and peri-implant diseases . Stacchi and coworkers concluded that there were no sufficient data to assess the role of smoking as a risk factor for implant loss and peri-implantitis. Both implant and patient-based meta-analyses revealed a significantly higher risk of developing peri-implantitis in patients with a history of periodontitis compared with periodontally healthy subjects, but not a statistically significant increased risk for implant loss (Stacchi et al., 2016).

Tobacco contains thousands of different substances and most of them represent harmful effects resulted from the systemic exposure following lung absorption. It also has effects on the oral microbiota, the gingival tissues, the inflammatory and immune response, and the healing capacity of the periodontium (Palmer et al., 2005).

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • men and women over 18 years old,
  • partially or totally edentulous patients with at least one implant placed at the university and loaded 7-19 years before,
  • cemented, screwed or mechanically retained prosthesis,
  • single, partial prostheses, and complete (fixed and removable),
  • patients diagnose of peri-implant health and peri-implantitis and
  • ability to understand study procedures.

排除标准

  • Some patient that does not follow the inclusion criteria

结局指标

主要结局

Predictive value of smoking habit on peri-implant diseases

时间窗: 1 day

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.

次要结局

  • Association between tobacco and peri-implant disease(1 day)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Josep Martínez

JMartinez

Universitat Internacional de Catalunya

研究点 (1)

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