To compare the effectiveness of subjective pain questionnaire v/s objective salivary pain biomarkers when pain experienced during fixed orthodontic treatment - An upcoming study.
- Registration Number
- CTRI/2018/12/016571
- Lead Sponsor
- Dr Sagar S Bhat
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1. Healthy pain â?? free subjects in the age group of 6 â?? 40 years.
2.Subjects should have good general health and also should be free of fever / cold and maintain exceptional oral hygiene on the day of collection.
1. Subjects having systemic disease affecting growth, for example disorders of vitamin D, parathyroid, growth and thyroid hormone, renal impairment, diabetes mellitus, bleeding disorders etc.
2.Subjects with any current pain, diagnosed systemic muscular or joint diseases such as fibromyalgia, clinical signs of temporomandibular disorders (TMD), rheumatoid arthritis, whiplash-associated disorder, neurological disorders, pregnancy or lactation, high blood pressure, tobacco usage, regular use of medications including oral contraceptives, use of antidepressants or analgesics during the last week, and oral complaints, such as oral dryness or mucosal lesions will be excluded.
3.Subjects with dental examination revealing less than 22 teeth, insufficient oral hygiene, hyposalivation, oral diseases, mucosal lesions or extensive tooth wear will be excluded from the study.
4.Subjects reporting elevated perceived levels of psychological distress will also excluded.
5.Subjects under any medications that could affect bone metabolism during the previous six months, for example: vitamin preparations, calcium supplements etc.
6.Subjects with a history of xerostomia.
7.Subjects who are on occupation during night time will be exempted from this study to avoid bias due to occupational influence of changes in concentration of salivary biomarkers and also diurnal variations of biomarkers in saliva.
8.Subjects with some other systemic and other localized pain due to any reason will be excluded.
9.Patients who are under analgesics medication will be excluded.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method