Evaluation of the effect of local administration of vitamin D3 on the maxillary canine retraction and the amount of external apical root resorption: A Prospective, Double blind, Split mouth randomized control clinical study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- The predictor variable is the canine retraction technique i.e. canine retraction with and without Vitamin D3 injection. The canine retraction is our primary outcome.
研究概览
简要总结
The study titled Evaluation of the Effect of Local Administration of Vitamin D3 on Maxillary Canine Retraction and External Apical Root Resorption is a prospective, double-blind, split-mouth, randomized controlled clinical trial. The primary objective is to assess the effect of intraligamentary Vitamin D3 injections on the rate of maxillary canine retraction. The trial will include patients undergoing orthodontic treatment that requires the retraction of maxillary canines. Each patient’s maxillary arch will be divided into experimental and control sides. The experimental side will receive Vitamin D3 injections which is diluted in lignocaine, while the control side will receive plain lignocaine. The study aims to determine whether Vitamin D3 can enhance the rate of tooth movement and reduce treatment duration, which is particularly beneficial for adult patients where bone metabolism is slower, leading to prolonged treatment durations. The study design ensures a high level of scientific rigor by using a randomized, double-blind approach, thereby reducing bias. Outcomes will be measured in terms of the rate of canine retraction, with regular follow-ups and measurements taken to ensure accurate results. This research could potentially lead to improved orthodontic treatment protocols, providing faster and more efficient outcomes for patients. The study will be conducted according to the 1975 Helsinki declaration guidelines revised in 2013. Statistical analysis will be done with SPSS version 22.0.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 15.00 Year(s) 至 30.00 Year(s)(—)
- 性别
- All
入选标准
- •Males and females Age range 15-30 years Critical anchorage Class I Bi-maxillary protrusion cases and Class II Div 1 malocclusion cases with ANB less than 5 degrees.
- •Good gingival and periodontal health (probing depth Good gingival and periodontal health (probing depth less than or equal to 3mm, gingival index score less than or equal to 1, plaque index less than or equal to 1) No systemic disease.
- •Patients requiring bilateral extraction of maxillary 1st premolar as part of their comprehensive treatment.
- •No endodontic lesions No dilaceration of canine roots as assessed on pre-treatment OPG No radiographic evidence of bone loss No history of periodontal therapy No current active periodontal disease Full development of teeth except 3rdmolars.
排除标准
- •Subjects with known hepatic or renal disease, Metabolic bone disease, History of allergy or autoimmune disease, Malabsorption, Type 1 diabetes, Hypercortisolism, Malignancy, Immobility for more than 1 week, Pregnancy, lactation, Medications influencing bone metabolism and any chronic consumption of anti inflammatory drug calcium, Vitamin D, calcium, and also fish oil supplement History of sun bathing after starting the orthodontic treatment Whose radiographs lacked visibility of upper incisors, Those with significantly distorted radiographs, crowding of teeth, unclear roots, and those with unilaterally and bilaterally lateral missing teeth in the maxilla.
结局指标
主要结局
The predictor variable is the canine retraction technique i.e. canine retraction with and without Vitamin D3 injection. The canine retraction is our primary outcome.
时间窗: Base time point is TO, then every monthly time point till four months i.e. T1, T2, T3, T4
次要结局
- Canine Rotations, external apical root resorption and molar rotations will be measured at monthly time intervals till 4 months from the base time point.(Base time point is TO, then every monthly time point till four months i.e. T1, T2, T3, T4)
研究者
DEVYANSHU SHARMA
Department of Orthodontics and Dentofacial Orthopedics,Bhojia Dental College and Hospital,Baddi, Dist. Solan, Himachal Pradesh 173205, India
