Skip to content

To compare the effectiveness of subjective pain questionnaire v/s objective salivary pain biomarkers when pain experienced during fixed orthodontic treatment - An upcoming study.

COMPARISON OF PAIN EXPERIENCED DURING FIXED ORTHODONTIC TREATMENT USING SUBJECTIVE PAIN QUESTIONNAIRES V/S OBJECTIVE SALIVARY PAIN BIOMARKERS â?? A PROSPECTIVE STUDY.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/12/016571
Enrollment
40
Registered
2018-12-10
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Pre-molar extraction with Fixed Orthodontic Treatment.: Patients with Class I malocclusion with crowding will be recruited in the study who will be subjected for pre-molar extraction. P

Sponsors

Dr Sagar S Bhat
Lead Sponsor
Dr Ameet V
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
-To access the concentration of CGRP and BDNF in whole unstimulated saliva its comparison with subjective pain scales VAS, VRS, NRS and MPQ, thus validating/invalidating the same.Timepoint: Samples will be collected under stipulated 5 time periods: immediately after bonding but before wire placement (baseline value), after 24 hours, 48 hours, 72 hours and after 7 days.

Secondary

MeasureTime frame
Not ApplicableTimepoint: Not Applicable

Countries

India

Contacts

Public ContactDr Sagar S Bhat

S D M College of Dental Sciences and Hospital, Sattur, Dharwad - 580009, Karnataka, India

drameetr@gmail.com09449178397

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 10, 2026