Evaluation the Effect of Coenzyme Q10 on Tissue Healing Process in Patients Undergoing Wisdom Tooth Extraction in the City of Sanandaj-Iran in 1402: a Double-blinded Clinical Trial Study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 主要终点
- Rate of Tissue healing
研究概览
简要总结
The goal of this clinical trial is to asses the effect of Coenzyme Q10 administration in patients from any gender group who are older than 18 years old undergoing wisdom tooth extraction. The main questions it aims to answer are:
does Coenzyme Q10 help with better tissue healing? does Coenzyme Q10 administration lower the prevalence of Dry socket after surgery? does Coenzyme Q10 prevent TMD (Temporomandibular disorders) while recovering from surgery? how does Coenzyme Q10 administration effect the answers to SF-36 health survey in patients? Researchers will compare Coenzyme Q10 to a placebo (a look-alike substance that contains no drug) to see if it has any effect on mentioned parameters.
Participants will:
- take coenzyme Q10 (100mg) daily for 30 days after surgery.
- will be examined and evaluated 1, 7, 14 and 30 days after completion of surgery.
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 (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients older than 18 years old that require mandibular or maxillary molar, third tooth extraction as Oral and Maxillofacial surgeon's clinical diagnosis.
排除标准
- •The patient's departure from Sanandaj
- •The patient's disagreement with the study protocol
- •The Patient's demise
- •The patient's hospitalization for unrelated illnesses
- •The patient's discontent with the care they received
- •The patient's failure to show up for follow-up appointments
- •The patient's sensitivity to Coenzyme Q10
研究组 & 干预措施
Intervention group
This arm of the study includes 35 of participants who will be given Coenzyme Q10 100 MG Oral Tablet for 30 days.
干预措施: Coenzyme Q10 100 MG Oral Tablet (Drug)
Control group
This arm of the study includes 35 of participants who will be given Placebo ( a look-alike substance ) with same tablet form given daily for a period of 30 days after surgery.
干预措施: Placebo (Drug)
结局指标
主要结局
Rate of Tissue healing
时间窗: 1, 7, 14 and 30 days after surgery
Regeneration-the replacement of damaged tissues with cells of the same type-and fibrosis-the replacement of damaged tissues with connective tissue-are the two primary processes involved in wound healing. To help in tissue healing, some cells, such as fibroblasts and vascular endothelial cells, have the ability to proliferate quickly in response to an external stimulation. Wound closure also requires non-proliferating cells, such as peripheral nervous system cells and odontoblasts. The bone that grows in to fill the space left by a tooth extraction should be similar to the surrounding healthy tissues. A lack of tissue healing is indicated by symptoms such as edema, fever, bleeding, discomfort, necrosis, exudate, flap instability, foul taste, and fistula. If trismus results from a muscle injury following an IAN Block injection, it should go away as the tissue heals.
次要结局
- Incidence of Temporomandibular disorders(1, 7, 14 and 30 days after surgery)
- Occurrence of Dry socket(1, 7, 14 and 30 days after surgery)
- Answers to The Short Form Health Survey-36(1, 7, 14 and 30 days after surgery)
- Answers to The General Health Questionnaire-12(1, 7, 14 and 30 days after surgery)
研究者
Zahra Nejati
Zahra Nejati, Dental student, Department of oral and maxillofacial medicine, School of Dentistry, Kurdistan University of Medical Sciences, Sanandaj, Iran.
Kurdistan University of Medical Sciences