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临床试验/CTRI/2022/08/044842
CTRI/2022/08/044842尚未招募不适用

To evaluate the effect of vibratory stimulation and low level laser therapy on the levels ofInterlukin-1 Beta, Interlukin-8 and amount of Tooth Movement

Dr Aastha Purohit1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年8月28日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
The efficacy of high frequency vibrations

研究概览

简要总结

Purpose & Background: Orthodontic treatment takes a long time therefore different methods like lasers and vibrations separately were used to increase orthodontic tooth movement thereby reducing treatment time. However, some studies showed a significant increase in tooth movement and some did not. Therefore, the purpose of this study is to compare the orthodontic tooth movement with the use of vibrations and lasers together with only lasers and without lasers or vibrations. If there is an increase in tooth movement the total treatment time will be reduced and therefore will be beneficial to both patient and the clinician.

30 patients coming to the Department of Orthodontics and Dentofacial Orthopaedics, Inderprastha Dental College and Hospital  requiring maxillary first premolar extraction will be considered for the study.

v  After patient selection, the patient will be informed about the study and if he/she agrees with the protocol, the consent form will be signed by the patient.

v All patients will  receive repeated oral hygiene instructions.

v (T0) : After both maxillary first premolar extraction a sample of GCF  will be collected to estimate the levels of IL-1 Beta and IL-8 from the pressure site of the right maxillary canine. Enzyme Linked Immunoassay (ELISA) would be done for this evaluation.

v Patients would be divided into two groups  having 15 patients each.

v Levelling and aligning procedures will be done.

v (D1): Distance between the cusp tip of canine and mesio buccal cusp tip of 1st molar will be measured using calliper.

v This is followed by canine retraction, which will be done by NiTi closed coil spring positioned from the canine bracket to the first molar buccal tube.

v Same material and method will be applied for canine retraction for both the groups.

v GROUP 1: No additional stimuli will be given.

v GROUP 2 : Patients of this group will be given a mechanical tooth brush with a high frequency of 150 Hz and will be asked to brush with it twice a day for six minutes each time (12 minutes).

Ø Laser Irradiation: On the right side of the maxilla of the patients of group 2 laser irradiation will be carried out.

v A medium InGaAsP Semi-conductor diode laser equipment (BIOLASE EPIC LASER)  will be used for the study, emitting infra-red radiation at 940nm, at a continuous wave mode. All irradiations will be done by the same operator with an output power of 100mW, and exposure time of 3 second at each point.

The tip will be held perpendicular to and in contact with the gingival mucosa during the laser irradiation procedure. Protection glasses were worn by both the operator and the patients. Total of 10 irradiations will be carried out each time, five on the buccal side and five on the palatal side of the canine of the laser group:v Two mesial,

v One medial,

v Two distal.

v Laser irradiation will be done  on 1st, 7th, 15th, 30th, 45th, 60th, 75th , 90th day of canine retraction.

v The procedure will be followed on all subsequent appointments.

v (T1): GCF fluid samples will again be collected at the end of three months from both the groups, which will be analysed for the levels of IL-1 beta and IL-8.

v (D2): The distance between the cusp tips of the canine and the mesio buccal cusp tip of the first molar will be measured with a caliper.

v The collected data will be compared and statistically analysed.

v ANOVA test will be carried out.

v A statistician will be consulted for expert opinion and modifications will be made if necessary.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Not Applicable

入排标准

年龄范围
14.00 Year(s) 至 45.00 Year(s)(—)
性别
All

入选标准

  • Healthy Individuals with no systemic illness requiring maxillary first premolar extraction.
  • Good oral hygiene and periodontal health.
  • No developmental anomaly.
  • No history of previous orthodontic treatment.

排除标准

  • History of trauma.
  • Patients with systemic illnesses Taking medications that interfere with orthodontic tooth movement Patients with parafunctional habits Severely periodontally compromised.
  • Periapical inflammation of cysts/ tumors.

结局指标

主要结局

The efficacy of high frequency vibrations

时间窗: 3 months

combined with low level laser therapy is

时间窗: 3 months

expected to be higher than low level laser

时间窗: 3 months

therapy which is higher than control group which

时间窗: 3 months

is not receiving any laser or vibration therapy on

时间窗: 3 months

the levels of Interleukin-1 beta and Interleukin-8

时间窗: 3 months

in Gingival Crevicular Fluid.

时间窗: 3 months

次要结局

  • Group receiving high frequency vibrations(combined with low level laser therapy is)

研究者

发起方
Dr Aastha Purohit
申办方类型
Other [self]

研究点 (1)

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