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临床试验/NCT07424300
NCT07424300已完成不适用

Bidirectional Relationship Between Oral Malodor And Olfactory Function In Generalized Periodontitis: A Prospective Cohort Study Evaluating Changes After Nonsurgical Periodontal Therapy

Batman University1 个研究点 分布在 1 个国家目标入组 101 人开始时间: 2024年12月3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
101
试验地点
1
主要终点
Change in Total TDI Score

研究概览

简要总结

This prospective cohort study investigated the relationship between oral malodor and olfactory function in adults with generalized periodontitis. A total of 101 patients were evaluated before and after routine nonsurgical periodontal therapy. Volatile sulfur compound (VSC) levels and psychophysical olfactory performance using the Sniffin' Sticks test (TDI score) were measured at baseline and one week after completion of three sessions of scaling and root planing (SRP). The study aimed to determine whether reduction of oral inflammation and halitosis is associated with improvement in olfactory performance.

详细描述

Generalized periodontitis is a chronic inflammatory disease associated with increased production of volatile sulfur compounds (VSCs), contributing to halitosis. Elevated intraoral malodor may interfere with olfactory perception through masking effects and inflammatory mechanisms.

Participants diagnosed with generalized periodontitis and complaining of halitosis underwent routine nonsurgical periodontal therapy consisting of three sessions of scaling and root planing performed at one-week intervals. Olfactory function (threshold, discrimination, identification; total TDI score) and total VSC concentrations were assessed at baseline (prior to first session) and one week after completion of the third session.

The study evaluated changes in chemosensory function and halitosis parameters following periodontal therapy and analyzed correlations between baseline VSC levels and olfactory performance.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Inclusion Criteria:
  • Adults aged 18-55 years
  • Diagnosis of generalized periodontitis
  • Complaint of halitosis
  • At least 15 natural teeth

排除标准

  • Self-reported smell loss or change within 2 weeks prior to baseline
  • Antibiotic or anti-inflammatory drug use for more than 7 days within the previous 6 weeks
  • Presence of upper respiratory tract infection
  • Unrestored advanced dental caries
  • History of COVID-19 infection
  • Pregnancy
  • Smoking was not an exclusion criterion.

研究组 & 干预措施

Generalized Periodontitis Patients With Halitosis

Adults aged 18-55 years diagnosed with generalized periodontitis and presenting with halitosis. Participants received routine nonsurgical periodontal therapy and were evaluated for olfactory function and volatile sulfur compound levels at baseline and after completion of therapy.

结局指标

主要结局

Change in Total TDI Score

时间窗: Baseline to 1 week after completion of third SRP session (approximately 4 weeks total)

Change in psychophysical olfactory performance measured by the Sniffin' Sticks Test (Threshold-Discrimination-Identification composite score). The Sniffin' Sticks Test total TDI score ranges from 1 to 48, calculated as the sum of: * Odor Threshold (1-16). * Odor Discrimination (0-16). * Odor Identification (0-16). Higher scores indicate better olfactory function.

Change in Total Volatile Sulfur Compound (tVSC) Levels

时间窗: Baseline to 1 week after completion of third SRP session

Change in total volatile sulfur compound (tVSC) concentration measured using the OralChroma portable gas chromatograph device. tVSC levels are reported in parts per billion (ppb). Higher values indicate greater halitosis severity (worse outcome).

次要结局

未报告次要终点

研究者

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

Mustafa Baran

Assistant Professor

Batman University

研究点 (1)

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