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临床试验/NCT03649789
NCT03649789已完成不适用

Retrospective Study of Periodontal Outcomes After Sanative Therapy in Patients With or Without Salivary Gland Hypofunction

Brock University2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2018年8月1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
120
试验地点
2
主要终点
Probing Depth

研究概览

简要总结

Salivary gland hypofunction, or dry mouth, is a damaging oral condition that affects salivary gland production. Absence of saliva causes bad breath, dental decay, increased plaque accumulation, dry lips, mouth sores, and the inability to retain dentures or removable protheses. This study will determine if patients with dry mouth have different periodontal health than patients without dry mouth. Additionally, this study will examine if patients who have their periodontal maintenance appointments solely at a periodontal speciality clinic have different periodontal health than patients who alternate their appointments between a specialty office and their general dental office.

详细描述

Salivary gland hypofunction, or dry mouth, is a damaging oral condition that affects the function and flow rate of saliva. Low saliva rates can range from mild self-reported symptoms and discomfort to significant oral diseases. Saliva is essential in preventing irritation and friction of mucosal surfaces. Progressively dry mouth can cause oral and bodily conditions that can affect an individuals quality of life and daily tasks, such as eating and avoiding social situations. Specifically, dry mouth is a risk factor for periodontal disease, a chronic oral inflammation of tissues and ligaments that support the tooth's structure and if untreated, will ultimately lead to tooth loss. In Canada, the first line of defense against periodontal disease is non-surgical sanative therapy (ST). Participants in this study have been attending a periodontal specialty clinic for routine periodontal maintenance appointments for at least 1 to 5 years following their initial scaling and root planing. Salivary flow rate will be measured to determine the level of dry mouth. At the regular maintenance appointment, clinical measures will be evaluated (probing depth, bleeding on probing, plaque index, gingival index, thickness of tissues, mobility, and furcations). Patients will also complete a dry mouth questionnaire to determine if dry mouth influences the day to day life of a patient, and the patient's Registered Dental Hygienist will complete a short questionnaire outlining oral symptoms of dry mouth. Additionally, the investigators aim to see if a patient who has periodontal maintenance appointments at a specialty office has different clinical outcomes than a patient who alternates these appointments between a specialty office and a general dental office. Overall, the investigators will determine if thorough periodontal maintenance appointments are efficient in preventing periodontal disease in patients with dry mouth.

研究设计

研究类型
Observational
观察模型
Cohort
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

  • have had sanative therapy at this clinic in the previous 1 to 5 years.

排除标准

  • anyone who is unable to provide informed consent

结局指标

主要结局

Probing Depth

时间窗: At maintenance appointment (1 hour) and retrospectively from the clinical record from time of sanative therapy onwards

Probing depth is a routine clinical measure of periodontal health (measured in mm)

次要结局

  • Frequency of Periodontal Maintenance Appointment only at the Periodontal Clinic(Will be reviewed from patient's clinical record over a time period of 1 to 5 years (this will represent the time period from recruitment and retrospectively until the time at which sanative therapy was performed))
  • Bleeding on Probing(At maintenance appointment (1 hour) and retrospectively from the clinical record from time of sanative therapy onwards)
  • O'Leary Index of Plaque Control(At maintenance appointment (1 hour) and retrospectively from the clinical record from time of sanative therapy onwards)
  • Thickness of Periodontal Tissue(At maintenance appointment (1 hour))
  • Frequency of Periodontal Maintenance Appointment at the Periodontal Clinic and General Dental Clinic(Will be reviewed from patient's clinical record over a time period of 1 to 5 years (this will represent the time period from recruitment and retrospectively until the time at which sanative therapy was performed))
  • Gingival Index (used to assess gingival condition to distinguish between the quality of gingiva and the location of gingival concerns).(At maintenance appointment (1 hour) and retrospectively from the clinical record from time of sanative therapy onwards)
  • Body Mass Index (BMI)(At maintenance appointment (1 hour))
  • Dry Mouth Inventory Questionnaire Completed by the Patient (to assess impact of dry mouth on quality of life)(At maintenance appointment (1 hour))
  • The Hygienist Observational Symptom Questionnaire (to assess whether a patient has dry mouth)(At maintenance appointment (1 hour))

研究者

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

Wendy E. Ward, Ph.D.

Professor and Canada Research Chair

Brock University

研究点 (2)

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