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临床试验/NCT07374536
NCT07374536进行中(未招募)不适用

Clinical and Radiographic Evaluation of Local Application of Melatonin on Postoperative Outcomes After Surgical Removal of Impacted Mandibular Third Molar: A Randomized Controlled Study

Suez Canal University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年9月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
20
试验地点
1
主要终点
Bone density

研究概览

简要总结

Clinical and Radiographic Evaluation of Local Application of Melatonin on Postoperative Outcomes after Surgical Removal of Impacted Mandibular Third Molar: A Randomized Controlled Study

详细描述

of all impacted teeth. The frequency of impaction of the mandibular third molar ranges from 33% to 58.7%. A tooth is considered to be impacted when its eruption time has passed or when the eruption interferes with the normal functional occlusion with other teeth or the overlying bone or soft tissues in the oral cavity.

The surgical removal of an impacted third molar is an everyday procedure in oral surgery clinics. However, it is known to disturb the quality of life of the patient by restricting the ability to chew food, open the mouth, and speak. Furthermore, there is a danger of periodontal damage on the distal root of the adjacent molar which could affect healing, 43% of the patients had a periodontal pocket depth of 7 mm or more at the distal root of the mandibular second molar 2 years post extraction of an impacted mandibular third molar.

The healing of periodontal defects related to the distal root of the adjacent molar may be compromised by intra-bony defects and bone loss after the removal of the impacted tooth. Alternative strategies, such as different flap designs, soft-tissue suturing, socket preservation, and tissue regeneration techniques with autologous bone, allografts, xenografts, or alloplastic grafts, have been proposed to prevent periodontal defects and physiological bone resorption after the surgical extraction of the mandibular third molar.

Melatonin is a growth hormone secreted mainly by the pineal gland and other structures, such as the retina, skin, gastrointestinal tract, lymphocytes, and bone marrow.It has antioxidant and anti inflammatory properties. It inhibits the production of reactive oxidants by reducing the expression of cyclooxygenase-2 and prostaglandin. In addition, it attracts polymorphonuclear cells to the site of injury.

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
None

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Both genders are included. 2)Adult patients (18-40) years 3)Healthy American Society of Anesthesiologists ASA I Patients. 4)Patients with class I or II impacted lower third molars with position A or B.

排除标准

  • Pregnant & lactating women.
  • Smoker patients.
  • Patients with poor oral hygiene.
  • Patients with bad oral habits as bruxism.
  • Patients with periapical or peri coronal lesions.
  • Patients with aggressive gingivitis or periodontitis.

研究组 & 干预措施

Control without Melatonin

Placebo Comparator

(the extraction socket will be left empty followed by suture of the socket after extraction

干预措施: Control (Diagnostic Test)

Study with Melatonin

Experimental

3 mg of melatonin into 2 ml of 2% hydroxyethyl cellulose gel will be packed into the socket after extraction

干预措施: Control (Diagnostic Test)

Study with Melatonin

Experimental

3 mg of melatonin into 2 ml of 2% hydroxyethyl cellulose gel will be packed into the socket after extraction

干预措施: Melatonin gel (Dietary Supplement)

Control without Melatonin

Placebo Comparator

(the extraction socket will be left empty followed by suture of the socket after extraction

干预措施: Melatonin gel (Dietary Supplement)

结局指标

主要结局

Bone density

时间窗: 1 and 4 months postoperatively

Assess relative bone density at the center of the extracted socket using digital periapical radiograph in the center of the socket.

次要结局

  • Post-operative pain levels(1, 3 and 7 days Postoperatively)
  • Measure Edema scale(1, 3 and 7 days Postoperatively)
  • Measure Maximal Mouth opening (MMO)(1, 3 and 7 days Postoperatively)
  • Measure the incidence of post-operative complications(1, 3 and 7 days Postoperatively)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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