A comparative evaluation of effect of vitamin D status on orthodontic bone remodelling using biomarkers in gingival crevicular fluid among young adults seeking orthodontic treatment- an in-vivo study.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- 1. To assess the Vitamin D levels of young adults seeking orthodontic treatment.
Study Overview
Brief Summary
45 patients fulfilling inclusion and exclusion criteria will be recruited for this study and Vitamin D level will be assessed in the serum before the start of maxillary canine retraction (T0). The patients will be classified into 3 groups- Vitamin D sufficient, insufficient, and deficient. Gingival crevicular fluid will be also collected from maxillary canines just before the start of maxillary canine retraction (T0). The retraction of the maxillary canine will be done using closed NiTi coil springs using 150 gms force and Gingival crevicular fluid will be collected again after 21 days of force application (T1). Gingival crevicular fluid samples will be analyzed for biomarkers NTx and P1NP levels responsible for bone remodeling using ELISA kits and compared among the three groups.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18.00 Year(s) to 25.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients with no gross skeletal dysplasia.
- •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.
- •Fully erupted set of permanent dentition except third molars.
Exclusion Criteria
- •Patients requiring treatment with functional jaw orthopedics or orthognathic surgery.
- •Presence of craniofacial anomalies.
- •presence of any signs and symptoms of gingival and periodontal diseases.
- •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.
- •Patients seeking medication for vitamin D deficiency.
Outcomes
Primary Outcomes
1. To assess the Vitamin D levels of young adults seeking orthodontic treatment.
Time Frame: 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).
2. To classify patients according to their Vitamin D status.
Time Frame: 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).
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 application
Time Frame: 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 Outcomes
- 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.(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.)
Investigators
Dr Ayushi Toley
Chhattisgarh dental college and research institute