Evaluation of the effect of vitamin D levels on bone changes in the mouth of young adults undergoing braces treatment

Not Applicable

• Conditions: Health Condition 1: K038- Other specified diseases of hard tissues of teeth

• Registration Number: CTRI/2024/04/065636
• Lead Sponsor: Dr. Ayushi Toley

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Patients with no gross skeletal dysplasia.

2. Patients with Angles Class I malocclusion with bimaxillary protrusion and minimal or no crowding requiring fixed orthodontic treatment indicated for bilateral maxillary first premolar extraction.

3. Fully erupted set of permanent dentition except third molars.

Exclusion Criteria

1. Patients requiring treatment with functional jaw orthopedics or orthognathic surgery.

2. Presence of craniofacial anomalies.

3. presence of any signs and symptoms of gingival and periodontal diseases.

4. Presence of significant medical history and medication known to affect the normal bone remodeling process like chemotherapy, radiation therapy, hormonal replacement therapy or bisphosphonate therapy, skeletal and bone disorders.

5. Patients seeking medication for vitamin D deficiency.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. To assess the Vitamin D levels of young adults seeking orthodontic treatment. <br/ ><br>2. To classify patients according to their Vitamin D status. <br/ ><br>3. To assess, evaluate and compare the concentration of NTx and P1NP biomarkers in gingival crevicular fluid of Vitamin D deficient, Vitamin D insufficient and Vitamin D sufficient patients before and after 21 days of force applicationTimepoint: The concentration of Vitamin D will be assessed in serum at the beginning (T0). The concentration of P1NP and NTx biomarker will be assessed in gingival crevicular fluid at the beginning (T0) and 21 days after force application (T1).

Secondary Outcome Measures

Name	Time	Method
1.Assessment of the baseline concentration of P1NP and NTx biomarkers in gingival crevicular fluid of Vit D Deficient, Vit D Insufficient and Vit D Sufficient subjects. <br/ ><br>2.Assessment of the correlation between P1NP and NTx biomarkers before and after orthodontic force application among Vit D Deficient, Vit D Insufficient and Vit D Sufficient groups. <br/ ><br>3.Determination of prevalence of Vit D Deficiency among the sample population. <br/ ><br>4.Determination of the demographical differences in Vit D status among the sample population.Timepoint: The concentration of Vitamin D will be assessed in serum at the beginning (T0). The concentration of P1NP and NTx biomarker will be assessed in gingival crevicular fluid at the beginning (T0) and 21 days after force application (T1).