Comparative Evaluation of Clinical and Radiographic Success of Oxymetazoline Versus Sodium Hypochlorite as Hemostatic Agents in MTA Pulpotomy of Primary Molars in a Group of Egyptian Children: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Clinical Success.
研究概览
简要总结
This study aims to evaluate clinical and radiographic success of oxymetazoline versus sodium hypochlorite as hemostatic agents in MTA pulpotomy of primary molars.
详细描述
The rationale for pulpotomy procedure is based on the healing capacity of the remaining pulp tissue following surgical amputation of the affected or infected coronal pulp. After achieving hemostasis, the exposed pulp stumps are covered either with a pulp-capping agent that promotes healing or with an agent that fixes the underlying tissue. MTA has been established as the gold standard medicament for pulpotomy owing to its several desirable properties such as biocompatibility, bioactivity, hydrophilicity, radiopacity, sealing ability and low solubility.
Besides the type of the pulp dressing material, one of the crucial parameters influencing the success of the pulpotomy procedure is the ability to control bleeding from the amputated pulp tissue. Selection of a hemostatic agent during pulpotomy has been a subject of extensive research and debate with respect to its influence on clinical and radiographic outcomes. The hemostatic agent provides not only hemostasis but also a sterile environment which is essential for pulp healing. Failure to achieve proper hemostasis means that blood will be continuously oozing out resulting in dislodgment of the placed medicament which will form a thick fibro purulent membrane over the pulpal tissue creating a dead space paving way for secondary infection and subsequent failure of the procedure. Furthermore, blood clot formation after hemostasis is undesirable because the fibrin present in the clot can act as a chemoattractant for polymorphonuclear leukocytes leading to prolonged pulpal inflammation.
Sodium hypochlorite (NaOCl) is one of the most popular hemostatic agents. It has tissue dissolution capacity by interfering with the cytoplasmic membrane integrity leading to irreversible enzymatic inhibition, biosynthetic change in cell metabolism, and phospholipid destruction in lipid peroxidation. It also helps in the formation of dentinal bridge. NaOCl has unique properties of simultaneous disinfection of dentine-pulp interface and chemical amputation of necrotic cells and blood clot. This ensures direct contact between pulp tissue and the capping material facilitating wound healing. In spite of its favorable antibacterial and hemostatic properties, NaOCl is considered cytotoxic. A histological study demonstrated that irrigating the tooth with 5.25% NaOCl after access opening resulted in damage to pre-dentine and dissolution of up to 4-5 layers of odontoblasts in the pulp tissue, consequently increasing the risk of internal root resorption after exposure of calcified tissue.
Furthermore, NaOCl was found to be hazardous to dental pulp stem cells (DPSCs) and hence it may theoretically cause a disturbance in pulp healing and negatively influence the outcome of the pulpotomy procedure. Moreover, NaOCl is believed to cause damage to the surrounding tissues, and alter the properties of the remaining tooth structure as it is associated with a significant decrease in dentin elastic modulus and flexural strength. Unpleasant taste and odor could also be added to the list of drawbacks of NaOCl.
Dental pulp tissue is innervated mainly by the autonomic nervous system, and activation of α-1 receptors causes vasoconstriction. Oxymetazoline (OXY) is a highly effective α -1 receptors agonist and can initiate hemostasis by vasoconstricting the smooth muscles associated with arterioles and venules in pulp tissue.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 8 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients: Egyptian children with carious mandibular primary molars aged 4-8 years.
- •Teeth: Restorable mandibular primary molars with no clinical signs or symptoms of irreversible pulpitis.
- •Pre-operative Radiograph: No radiographic signs of internal or external root resorption and no furcation or periapical radiolucencies.
排除标准
- •• Patients:
- •Uncooperative children.
- •Medically compromised children.
- •Patients whose parents refuse to participate or refuse to sign the informed consent.
- •Previously accessed molars.
- •Mobile primary molars.
- •Presence of sinus tract or pain on percussion.
结局指标
主要结局
Clinical Success.
时间窗: Clinical evaluation will be performed at 1,3 &6 months postoperatively
•Spontaneous pain: will be evaluated by asking the patient and/or guardian. Unit of measurement: Binary.
clinical success
时间窗: Clinical evaluation will be performed at 1,3& 6 months postoperatively.
Pain to percussion: will be tested through percussion test (using the back of the dental mirror). Unit of measurement: Binary
Clinical success:
时间窗: Clinical evaluation will be performed at 1,3&6 months postoperatively.
• Sinus or fistula: will be evaluated through visual examination. Unit of measurement: Binary (yes or No)
Clinical success
时间窗: Clinical evaluation will be performed at 1,3&6 months postoperatively.
Pathologic mobility: will be evaluated by mobility test (pressure using the ends of two dental mirrors.) Unit of measurement: Binary (yes or No)
次要结局
- Radiographic success.(Radiographic evaluation will be performed at 3 & 6 months postoperatively.)
- Radiographic success(Radiographic evaluation will be performed at 3 & 6 months postoperatively.)
- Radiographic succces(Radiographic evaluation will be performed at 3 and 6 months postoperatively.)
研究者
Mariam Medhat
Pediatric dentistry resident
Cairo University
