跳至主要内容
临床试验/NCT06063460
NCT06063460Enrolling By Invitation不适用

Investigation of Halitosis, Taste and Smell in Terms of Periodontal Condition Stated by Patients and Periodontal Diagnosis by Dentists, and Then Evaluation of Change Before and After Treatment

Necmettin Erbakan University1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2023年10月10日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
180
试验地点
1
主要终点
Comparison of halitosis taste and smell perception measured by VAS scale in gingivitis and periodontitis groups, at baseline and 1 month after initial treatment

研究概览

简要总结

The goal of this observational study is to evaluate the effect of non-surgical periodontal treatment on patient halitosis, smell, and taste perception in gingivitis and periodontitis patients. The main questions it aims to answer are:

  • Do gingivitis, periodontitis, and gingival health affect the patient's halitosis, taste, and smell perception?
  • Does non-surgical treatment affect the patient's bad breath, perception of taste and smell? Participants will be informed about the study. No additional intervention will be performed for the study, and patients will continue their routine periodontal treatments.

详细描述

This research will involve 180 individuals aged 18 to 65 who applied to the Department of Periodontology at the Faculty of Dentistry at Necmettin Erbakan University for various reasons. The investigation is scheduled for September to December of 2023. After clinical and radiological evaluation, each patient diagnosed with periodontal disease in the Department of Periodontics receives initial phase-1 treatment.

Individual preference If patients who seek periodontal treatment at the Periodontology Clinic Secretariat meet the study's inclusion criteria, they will be included in the study if they agree to fill out sociodemographic information such as age, gender, education level, a visual analog scale, and a self-reported periodontal status survey prior to treatment and sign the consent form. In the investigation, participants will be diagnosed with periodontium that is clinically healthy, gingivitis, and periodontitis.

Our research is a prospective survey investigation. In the study, researchers will ask patients undergoing routine periodontal examinations in the clinic and for whom treatment is planned to complete questionnaires beforehand. Tracking of survey responses will continue until the total number of respondents has been reached. Patients will resume their routine phase 1 treatment after completing the questionnaires.

Periodontal Examination Routine In routine periodontal examination, measurements of plaque score, gingival score, pocket depths, and attachment loss will be utilized. Plaque accumulation; According to the PI defined by Silness and Löe, 0: no plaque; 1: plaque at the end of the probe; 2: plaque visible to the naked eye; 3: will be evaluated as excessive plaque accumulation. Gingival index: According to Loe and Silness, 0 indicates healthy gingiva; 1 indicates mild inflammation and discoloration, with no bleeding on probing; 2 indicates moderate inflammation, hyperemia, and bleeding on probing; and 3 indicates severe inflammation, hyperemia, ulceration, edema, and spontaneous bleeding.

Patients will be treated in accordance with the 2017 World Workshop on Classification of Periodontal and Peri-Implant Diseases and Conditions. Clinical gingival health will be defined as a probing depth of less than 3 mm and a bleeding area of less than 10%. Periodontitis will be diagnosed if interdental clinical attachment loss (CAL) is detected in 2 nonadjacent teeth or if more than 3 mm of buccal or oral CAL is detected in 2 teeth with a probing depth of 3 mm. The severity of periodontitis will be determined using a system of stages and grades. The interdental CAL at the site of the greatest loss will be used to define the four stages. Stage is used to categorize the severity and complexity of periodontitis (Stage I-II-III-IV), while grade is used to estimate the likelihood of case progression (Grades A and B).

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 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Volunteers between the ages of 18-65
  • Healthy periodontium, getting diagnosed with gingivitis or periodontitis

排除标准

  • Not agreeing to participate in the study
  • Having a psychiatric, mental or physical disability
  • Having received periodontal treatment in the last 6 months
  • Being pregnant and lactating
  • Any antibiotics that may affect periodontal tissues for any reason in the last 6 months
  • Having used an anti-inflammatory or other medication

结局指标

主要结局

Comparison of halitosis taste and smell perception measured by VAS scale in gingivitis and periodontitis groups, at baseline and 1 month after initial treatment

时间窗: 1st month

At the 1st month after the initial treatment, the halitosis, taste and smell perceptions of the participants in all groups will be measured with the VAS scale. The initial and 1st month results of the groups will be compared with each other. The senses of taste and smell were collected using a visual analogue scale (VAS), where the participants were asked to rate their ability to taste or smell. The value zero represented "no taste" or "no smell," and 100 described "excellent taste" or "excellent smell" . Halitosis was considered the mediator and was measured using a VAS, where the participants were asked to rate their breath odor. The scale went from a value of zero, corresponding to "no bad breath," to 100, corresponding to "extremely bad breath".

Comparison of halitosis taste and smell perception measured by VAS scale in gingivitis and periodontitis groups, at baseline and 3 month after initial treatment

时间窗: 3rd month

At the 3rd month after the initial treatment, the halitosis, taste and smell perceptions of the participants in all groups will be measured with the VAS scale. The initial and 1st month results of the groups will be compared with each other. The senses of taste and smell were collected using a visual analogue scale (VAS), where the participants were asked to rate their ability to taste or smell. The value zero represented "no taste" or "no smell," and 100 described "excellent taste" or "excellent smell" . Halitosis was considered the mediator and was measured using a VAS, where the participants were asked to rate their breath odor. The scale went from a value of zero, corresponding to "no bad breath," to 100, corresponding to "extremely bad breath".

Difference between halitosis, smell and taste perception measured by VAS scale in gingival health, gingivitis and periodontitis groups at baseline

时间窗: Baseline

The senses of taste and smell were collected using a visual analogue scale (VAS), where the participants were asked to rate their ability to taste or smell. The value zero represented "no taste" or "no smell," and 100 described "excellent taste" or "excellent smell" . Halitosis was considered the mediator and was measured using a VAS, where the participants were asked to rate their breath odor. The scale went from a value of zero, corresponding to "no bad breath," to 100, corresponding to "extremely bad breath". 3 groups will be compared to each other.

次要结局

未报告次要终点

研究者

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

Zeynep Tastan Eroglu

Assistant professor

Necmettin Erbakan University

研究点 (1)

Loading locations...

相似试验