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.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- 1. To assess the Vitamin D levels of young adults seeking orthodontic treatment.
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 25.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
1. To assess the Vitamin D levels of young adults seeking orthodontic treatment.
时间窗: 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.
时间窗: 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
时间窗: 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).
次要结局
- 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.)
研究者
Dr Ayushi Toley
Chhattisgarh dental college and research institute