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临床试验/NCT06164509
NCT06164509尚未招募4 期

Healing Potentiality of Different Doses of Trypsin and Alpha Chemo Trypsin in Mandibular Molars With Chronic Apical Abscess

Ain Shams University1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2023年12月20日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
尚未招募
入组人数
45
试验地点
1
主要终点
Lesion size and bone Formation will be measured by cone-beam computed tomography

研究概览

简要总结

assessment of healing potentiality of peri apical lesions using different doses of trypsin and alpha chemo trypsin in mandibular molars with chronic apical abscess

详细描述

Owing to anti-inflammatory, anti-oedematous, fibrinolytic, anti-infective, and analgesic effects, trypsin:

chymotrypsin oral combination has emerged as a promising treatment of mandibular molars with chronic apical abscess. Trypsin chymotrypsin combination always showed a significant reduction in swelling and pain postoperatively.

Study procedures:

  1. According to inclusion and exclusion criteria; patients will be subjected to complete history taking, general and local "dental" examinations.
  2. Important dental symptoms will be assessed include bleeding, pain, malocclusion, new growths, numbness or paresthesias, and chewing problems.
  3. General information will be reported including use of alcohol or tobacco and systemic symptoms, such as fever and weight loss.
  4. A thorough inspection with good illumination, a tongue blade, gloves, and a gauze pad will be performed.
  5. Complete or partial dentures will be removed so that underlying soft tissues can be seen.
  6. A head-mounted light will be used. However, because the light cannot be precisely aligned on the axis of vision, it is difficult to avoid shadowing in narrow areas.
  7. Better illumination results will be performed with a head-mounted convex mirror.
  8. The temporomandibular joint (TMJ) will be assessed by looking for jaw deviation on opening and by palpating the head of the condyle anterior to the external auditory meatus.
  9. Examiner then place his little fingers into the external ear canals with the pads of the fingertips lightly pushing anteriorly while patients repeatedly open widely and then close.
  10. Preoperative preapical X-ray and CBCT will be done.
  11. Cases will be randomly divided into 3 groups; Group A will receive (Alphintern®, tablet, Amoun, Egypt), Group B will receive (Limitless Allzyme Max®, tablet, Eva, Egypt) Group C will not receive medication
  12. Medications will be taken three times daily for 7 days postoperative, after that all cases will be reexamined regarding healing rate, adverse effect and failure rate of medical treatment.
  13. Randomization, allocation and concealment: It will be done using computer generated randomization sheet. Sealed opaque packages will be given to a third person (nurse) who will assign the packages to study groups. Each patient will be invited to pull out a package. According to the number inside package, cases will be allocated to either group A, B or C according to a computer- generated random list.
  14. Postoperative preapical X-ray will be done at the end of the root canal treatment.
  15. Patient will be recalled after three months for preapical X-ray assessment.
  16. After six months patient will be recalled for preapical X-ray and CBCT to be done.

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 (Investigator, Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • Age: any age group.
  • Both genders.
  • Cases with mandibular molars with chronic apical abscess

排除标准

  • Patients with significant comorbidities like uncontrolled diabetes mellitus, hypertension, hepatic or renal disorders.
  • Immunocompromised patients.
  • Patient with allergy from study medications.

研究组 & 干预措施

Alphintern

Active Comparator

Group A will receive (Alphintern® tablet, Amoun, Egypt),

干预措施: Alphintern® , tablet, Amoun, Egypt (Drug)

Alzyme Max

Active Comparator

Group B will receive (Limitless Allzyme Max®, tablet, Eva, Egypt)

干预措施: Alphintern® , tablet, Amoun, Egypt (Drug)

结局指标

主要结局

Lesion size and bone Formation will be measured by cone-beam computed tomography

时间窗: 6 months

cone-beam computed tomography will be done Before Drug is given and after 6 months

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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