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临床试验/CTRI/2024/11/076441
CTRI/2024/11/076441尚未招募不适用

EVALUATION OF EFFICACY OF AQUA TITAN PATCH IN POSTOPERATIVE SEQUELAE AFTER IMPACTED MANDIBULAR THIRD MOLAR SURGERY – A RANDOMIZED CONTROL TRIAL

Geetanjali Dental & Research Institute1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2024年11月12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
44
试验地点
1
主要终点
Pain

研究概览

简要总结

Extraction of mandibular third molar is most accomplished procedure in oral surgery. The prevalence of impacted lower third molar ranges from 16.7% - 68.8%.Indication for third molar surgery includes pericoronitis, periodontal defect on distal aspect of 2nd molar, dental caries, involvement of mandibular 3rd molar in various odontogenic tumors and cyst and 6 months prior to Bilateral sagittal split osteotomy.

Pain, oedema, and trismus are the most common post-operative sequalae after surgical removal of the mandibular third molar which may affect the quality of life of the patient. These post-operative sequelae further depend upon the location, depth, tooth angulation, bone density and duration of the surgery. Various studies had been done in literature with various methods to improve the control of pain, oedema, and trismus and to accelerate postoperative recovery period.

These attempts include use of various anesthesia alone and in combinations, corticosteroids, incorporation of drains, platelet rich-plasma, using high or low speed rotatory instruments for osteotomy, cryotherapy, postoperative ice-packs, lasers, and physiotherapy.

Titanium has been reported to have beneficial physiological effects such as anti-inflammatory, anti-tumor, anti-oxidant, and stimulation of nerve cell growth. As per Rowlands et al the application of aqua titan patch has been advantageous for the repair of muscle-tendon components. Basically, aqua titan is a material compromising microscopic titanium particles dispersed in water, achieved through a processing technology, developed by phiten co. (Kyoto, Japan). Aqua titan can be applied to many products in collaboration with other materials to promote health in daily life and has received attention recently in variety of fields.

Nishiyama et al reported that aqua titan- permeated patches are beneficial in relieving TMD- related pain in improving TMD-related limitation to daily function by local application to most painful area, including the muscle and joints of patients and advantages for relieving muscle pain.

There are ample number of studies in literature regarding the use of NSAIDS, steroids, PRP, PRF, lasers, cryotherapy for the management of post-operative pain, swelling and trismus. As per best  of our knowledge, there is scarcity of literature regarding the use of aqua titanium patch for the management of pain, swelling and trismus after impacted mandibular third molar surgery.

Therefore, the present study will be done to evaluate the efficacy of aqua titanium patch in post- operative sequel after mandibular third molar surgery

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

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

入选标准

  • Patients between age of 18-45 years of both genders.
  • Patients indicated for surgical removal of impacted mandibular third molar.
  • Healthy patients falling under ASA I and ASA II
  • Subjects able and willing to provide written informed consent and compliant with study procedure.

排除标准

  • Patients with mouth opening less than 30mm.
  • Patient with allergy with NSAIDS.
  • Patients having history of drug abuse.
  • Patients having any systemic or local immunodeficiency.
  • 5.Patient is under regular analgesics and anti-depressants.
  • •Having any blood coagulation impairment.
  • •Have been suffering with uncontrolled diabetes or other systemic diseases.
  • •Having previous history of radiation therapy in the head and neck region.
  • •Pregnant and nursing women.
  • •Soft tissue impactions.

结局指标

主要结局

Pain

时间窗: all these parameters will be measured on 1st, 3rd and 7th post operative day

Swelling

时间窗: all these parameters will be measured on 1st, 3rd and 7th post operative day

Trismus

时间窗: all these parameters will be measured on 1st, 3rd and 7th post operative day

次要结局

未报告次要终点

研究者

发起方
Geetanjali Dental & Research Institute
申办方类型
Research institution
责任方
Principal Investigator
主要研究者

Dr Neha Patel

Geetanjali Dental and Research Insitute

研究点 (1)

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