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临床试验/NCT07326319
NCT07326319已完成不适用

The Effect of Periodontal Treatment on Tongue Coating and Olfactory Functions in Patients With Periodontitis

Batman University2 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2024年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
108
试验地点
2
主要终点
Change in Olfactory Function (TDI Score) Following Periodontal Treatmen

研究概览

简要总结

This study aims to investigate the effect of periodontal treatment on olfactory function in patients with periodontitis by comparing pre- and post-treatment periodontal indices, Winkel tongue coating scores, and Sniffin' Sticks TDI components.

详细描述

Periodontitis is a multifactorial chronic inflammatory disease caused by dental plaque, characterized by connective tissue destruction, periodontal pocket formation, and alveolar bone loss. Pathogenic bacteria associated with periodontitis and the host inflammatory response contribute not only to periodontal tissue breakdown but also to oral malodor (halitosis) and disruption of the oral microbiota. Progressive periodontal inflammation promotes the formation of a dense biofilm on the dorsum of the tongue, containing bacterial products, keratinized epithelium, and protein residues. This leads to increased tongue coating, which serves as a primary source of volatile sulfur compounds (VSCs) strongly associated with halitosis.

The Winkel Tongue Coating Index (WTCI) is commonly used to assess tongue coating and is an important clinical indicator for both halitosis and periodontal status. The bacterial load on the tongue also acts as a reservoir, contributing to dysbiosis of the oral microbiota in periodontitis patients.

Recent studies have also highlighted a potential relationship between periodontitis and olfactory function. Proinflammatory cytokines released during periodontal inflammation, such as IL-1β, TNF-α, and IL-6, may negatively affect the olfactory epithelium, leading to impaired odor threshold, discrimination, and identification abilities. Olfactory function is commonly evaluated using the Sniffin' Sticks test, which includes three subtests: odor threshold, odor discrimination, and odor identification. The sum of these tests, known as the TDI score, reflects overall olfactory capacity.

Previous studies have shown that periodontal treatment can improve tongue coating and halitosis. However, studies simultaneously evaluating pre- and post-treatment tongue coating indices, periodontal indices, and olfactory function (TDI scores) are limited. The aim of this study is to compare these parameters before and after periodontal treatment in patients with periodontitis and to investigate the effect of periodontal therapy on olfactory function.

This study was approved by the Batman University Interventional Clinical Research Ethics Committee (Approval No: 2024/08-04). All procedures and data collection were conducted in accordance with the Declaration of Helsinki, and all participants provided written informed consent.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

盲法说明

No parties are masked in this study; it is an open-label trial.

入排标准

性别
All
接受健康志愿者

入选标准

  • Adults with a clinical diagnosis of periodontitis
  • At least two teeth with probing pocket depth (PPD) ≥ 5 mm
  • Alveolar bone loss visible on full-mouth radiographs
  • Non-smokers
  • Ability to provide written informed consent

排除标准

  • Current smokers
  • Periodontal treatment within the past 6 months
  • Pregnancy or breastfeeding
  • Antibiotic use within the past 3 months
  • Systemic diseases or conditions known to affect olfactory function

结局指标

主要结局

Change in Olfactory Function (TDI Score) Following Periodontal Treatmen

时间窗: Time Frame: Baseline (before periodontal treatment) and 3 days after the final treatment session

The primary outcome of this study is the change in olfactory function following non-surgical periodontal treatment. Olfactory function is assessed using the Sniffin' Sticks Test Battery, which consists of three subtests: odor threshold, odor discrimination, and odor identification. The sum of these three subtests yields the TDI score, with a total score ranging from 1 to 48. Higher TDI scores indicate better olfactory function. Measurements are performed at baseline, prior to periodontal treatment, and three days after completion of the final treatment session in order to evaluate short-term changes in olfactory function attributable to periodontal therapy. This pre-post comparison allows each participant to serve as their own control.

次要结局

  • Change in Tongue Coating Index Score(Baseline (pre-treatment) and 8 weeks after completion of periodontal treatment)

研究者

发起方
Batman University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gulucag Giray Tekin

Assistant professor

Batman University

研究点 (2)

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