Comparison and Evaluation of The Rate of Tooth Movement between Vitamin D and Injectable Platelet Rich Fibrin A Randomised Controlled Trial
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Canine retraction in mm
研究概览
简要总结
Aim: To determine and compare the effects of local injection of Calcitriol and injectable platelet-rich fibrin on the rate of Canine retraction.
Objectives:
-
To evaluate the retraction of Canine in mm
-
To evaluate change in Canine rotation in degrees
-
To study the pain experience between the 2 groups
Methods:
Sample Size Calculation was done based on the statistical evaluation of a previous study performed by Erdur et al in 2021(Erdur et al., 2021). The Sample calculation was done using G-power software with a power of 95%. A sample of N=5 quadrants (n=5/group) was obtained, however, based on the advice of the SRB board, keeping attrition and bias due to the small sample size into consideration, a final sample size of 10 was decided upon (n=10/group).
Inclusion Criteria
Patients requiring Mini-implant assisted retraction of the Maxillary Canines using MBT prescription with an 0.022 slot and on a 0.019" x0.025" Stainless Steel Archwire
â—Adults between 18 years and 35 years
â— No systemic illness, or absence of bone metabolic disorders.
â— Periodontally healthy subjects.
â— Good oral hygiene.
Exclusion Criteria
â— Patients unwilling to participate in the study.
â— Patients with a history of anemia, blood loss, or vascular diseases.
â— Patients with a history of smoking
â— Patients on long-term use of steroids, bisphosphonates, and NSAIDs.
A split-mouth randomized clinical trial was planned. Based on the selection criteria, the patients included in this study required extraction of the first maxillary premolars. The extractions were carried out a minimum of a month before the start of this study, to avoid the interference of the regional acceleratory phenomenon (RAP). The patients were undergoing fixed appliance therapy with 0.22 Metal MBT brackets (AO mini master standard edgewise, USA) and were at the end of the Leveling and Aligning stage and canine retraction was carried out on 0.019 x 0.025 Stainless Steel archwire. To ensure absolute anchorage, mini-implants(8mm x 1.5mm, SK Surgical, India) were placed by the same operator (NV) at the junction of the attached gingiva and the movable mucosa, in the region between the second premolar and the first molar in the maxillary arch. An IOPA was taken to confirm the position of the mini-implants to assure stability.
Preparation of I-PRF and Intervention
5-10 ml of venous blood of the patient was collected.The collected blood was then subjected to the double centrifuge technique proposed by Marx et al and Rashid et al (Rashid et al., 2017)(Marx and Garg, 2005; Rashid et al., 2017). 0.2ml of iPRF was injected intraligamentary in the disto-buccal, middle and disto- palatal points of the Maxillary Canine. Immediately post I-PRF injection, the same volume of saline was injected in the control side.
Preparation of Vitamin D
Vitamin D3 (1,25-dihydroxyvitamine D3, the active form of vitamin D3) sachets(Calcitriol, Mibe, Germany) were used to prepare a diluted dose (50 pg) for local injections. Dimethylsulfoxide (0.2 ml) (DMSO, Bisolve B.V., Netherlands) was used for dilution and worked as a vehicle). 0.2ml of the solution was injected intraligamentary in the disto-buccal, middle and disto- palatal surface of the Maxillary Canine, while the contralateral canine received an intraligamentary administration of saline only as a control.
Application of Force and Records Taken
Post-intervention, Canine retraction was initiated using elastomeric e-chains with 150 grams of force on each side from each Canine to the mini-implant. A Lateral Cephalogram was taken and day 0 of the intervention, and subsequently after 90 days of the start of the study. Intra Oral scan was taken using Runye Intraoral Scanner on day 0 of the intervention, and subsequently after 30 days, 60 days, and 90 days.
The scans were superimposed on each other using 3Shape Ortho Analyser software. Superimposition of the T0 scan and the following scans were done to rule out mesial movement(loss of anchorage) of the second premolar. Points were marked from the distal-most point on the canine and mesial-most point of the second premolar. The rate of canine distalization was calculated from the difference in this measurement between the scans at different periods. Degree of rotation was compared using a line drawn from the mesial and distal surface and compared to a line passing through the mid-palatal raphe.
Pain Perception
The pain perception of the patients was evaluated on each side: control and intervention at the time of intervention, after 24 hours of the intervention and after 1 week, using a Visual Analog Scale (VAS).The patients were advised to not use any analgesics during this period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 35.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients requiring Mini-implant assisted retraction of the Maxillary Canines using MBT prescription with an 0.022 slot and on a 0.019" x0.025" Stainless Steel archwire Adults between 18 years and 35 years No systemic illness, absence of bone metabolic disorders.
- •Periodontally healthy subjects.
- •Good oral hygiene.
排除标准
- •Patients unwilling to participate in the study.
- •Patients with a history of anemia, blood loss or vascular diseases.
- •Patients with history of smoking Patients on long term use of steroids, bisphosphonates and NSAIDS.
结局指标
主要结局
Canine retraction in mm
时间窗: Day of the intervention(T0) | 4 weeks from T0 (T1) | 8 weeks from T0 (T2) | 12 weeks from T0 (T3)
次要结局
- Canine rotation in degrees(T0 and T3)
- Pain experience using a Visual Analogue Scale(T0, 24 hours from T0, 1 week from T0)
研究者
Dr Nazleen Valerie Vas
Saveetha Dental College and Hospitals
