Evaluation of Clinical Efficacy of Locally Injected Vitamin D3 (Calcitriol or 1,25 Dihidroxicolecalciferol) in Accelerating Orthodontic Tooth Movement (A Randomized Controlled Trial)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Primary Outcome Measure was the overall time needed to complete leveling and aligning (OLAT) the mandible dental arch
研究概览
简要总结
EVALUATION OF EFFICACY OF LOCALLY INJECTED Vitamin D3 (calcitriol or 1.25 dihidroxicolecalciferol) IN ACCELERATING ORTHODONTIC MOVEMENT Design: A randomized, controlled, crossover, double-blind clinical study including Eighteen adult , aged 15-25 years old.
详细描述
The rate of orthodontic tooth movement depends on two general factors: the forces used in order to cause orthodontic tooth movement and respectively the individual (biological) response of the body to these forces.
There are many methods for accelerating orthodontic tooth movement. but, every method has its disadvantages, such as pain and root absorption. Locally injected of vitamin d3 was proposed to accelerates tooth movement with minimal disadvantages, but there aren't enough clinical studies to prove this claim.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
The participant will be blinded, the drug administrator will be blinded too, and the investigator who will give the treatment and explain the pain scale to the participant and ask him\her to point to the face that fits the degree of his pain that associated with the drug administration will also be blinded.
入排标准
- 年龄范围
- 15 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mild to moderate crowding of mandible teeth. In accordance with LITTLE'S IRREGULARITY INDEX
- •Healthy patient
- •No previous orthodontic treatment
- •Vital teeth with periodental tissue without root absorption,
排除标准
- •Previous history of orthodontic or orthopedic treatment.
- •Presence of craniofacial anomalies.
- •Presence of any signs and symptoms of gingival and periodontal diseases.
- •Presence of significant medical history (including drug allergy).
- •Pregnant and lactating women.
研究组 & 干预措施
Group 1
Six participants were bonded with 0.022 × 0.028 inch slot brackets (Ortho Smile) using pre-adjusted edgewise appliance with 0.022 MBT prescriptions. Local periodontal injection of 1,25 DHC at weekly interval (3 times). The gingival fluid volume will measured befor and after 1-1.5 hours after first injection. the same is done visit at the second and third visits. Pain during injection and treatment will be assessed using the FLACC scale and face scale
干预措施: Dihydroxycholecalciferols (Drug)
Group 2
Six participants were bonded with 0.022 × 0.028 inch slot brackets (Ortho Smile) using pre-adjusted edgewise appliance with 0.022 MBT prescriptions. Local periodontal injection of dimethylsulfoxide at weekly interval (3 times). The gingival fluid volume will measured befor and after 1-1.5 hours after first injection. the same is done visit at the second and third visits. Pain during injection and treatment will be assessed using the FLACC scale and face scale.
干预措施: dimethyl sulfoxide (Other)
Group 3
Six participants were bonded with 0.022 × 0.028 inch slot brackets (Ortho Smile) using pre-adjusted edgewise appliance with 0.022 MBT prescriptions. ocal periodontal injection of serum at weekly interval (3 times). The gingival fluid volume will measured once. Pain during treatment will be assessed using the FLACC scale and face scale.
干预措施: serum (Other)
结局指标
主要结局
Primary Outcome Measure was the overall time needed to complete leveling and aligning (OLAT) the mandible dental arch
时间窗: 6 months
To calculate outcome measures, a mandible alginate impression was taken to make study casts at three time points: before insertion of the first archwire (T0), after 1 month of treatment commencement (T1), and at the end of the leveling and alignment stage (T2), represented by final archwire insertion. LII was used to measure the change in tooth alignment on the casts. It involved measuring the horizontal linear distance among adjacent contact points of the six anterior teeth. The sum of these five measurements gave the value of the index. LII was measured using a digital caliper to the nearest 0.01 mm by the corresponding author. OLAT was calculated by the number of days between T0 and T2.
次要结局
- Second Outcome Measure was leveling and alignment improvement percentage (LAIP) of the Mandible teeth throughout the leveling and alignment stage.(6 months)
- VAS scale(3 weeks)