Comparative Evaluation of Melatonin Versus Mineral Trioxide Aggregate on Vital Pulp Therapy in Young Permanent First Molars: An in Vivo Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Radiographic assessment (using Image J software program)
研究概览
简要总结
The process of dental caries is dynamic and can be either reversible or irreversible depending on the balance between protective and pathologic factors in the oral cavity. Untreated dental caries causes pulpal injury, inflammation, and necrosis. Melatonin plays an essential role in the regulation of bone growth. The actions that melatonin exerts on odontoblasts may be similar to its action on osteoblasts.
详细描述
The aim of this study is to evaluate and compare the pulp response of young permanent first molars after apexogenesis procedure, using melatonin versus MTA clinically and radiographically. This study will be performed on 45 young permanent first molars that will be divided equally into three groups according to the material used following apexogenesis; GroupI: MTA, GroupII: Melatonin and GroupIII: MTA and Melatonin. apexogenesis procedures will be carried out in children aged 6 to 8 years old. This will be followed by placement of MTA or/and Melatonin material as a sub base in the pulp chamber according to the group. Then, placement of a conventional glass ionomer cement (FUGI IX) as a permanent restoration will be conducted. Then, an immediate postoperative periapical digital x-ray film will be taken for the patients. The patient follow-up will be assigned 1,3,6,9 and 12 months after treatment.
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
- Single (Participant)
入排标准
- 年龄范围
- 6 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •1- Apparently healthy and medically free children. 2- Their age ranges from 6-8 years. 3- Both boys and girls will be included. 4- Children should have mandibular permanent first molars with the following clinical and radiographic criteria. 4.1Restorable young permanent first molars. 4.2Absence of clinical evidence of pulp degeneration:
- •No history of spontaneous pain, history of night pain or pain that not relieved by analgesics.
- •No pain on percussion.
- •No mobility.
- •Absence of abscess, purulent sinus or soft tissue edema.
- •Bleeding should stop within 5 minutes after the amputated pulp stumps.
排除标准
- •Internal root resorption.
- •External root resorption.
- •Inter radicular or periapical bone destruction (radiolucency)
- •A deep carious lesion radiologically that approaches the pulp
研究组 & 干预措施
Mineral Trioxide and Melatonin
Mixture of the two materials' powders.
干预措施: Mineral trioxide aggregate (dressing material) (Drug)
Mineral Trioxide Aggregate
is a powder that consist of Calcium oxide, silicone dioxide, aluminum oxide, bismuth oxide, purified water. It is a bactericidal dressing material, promotes pulp healing, and does so without producing inflammation and promotes dentin bridge formation.
干预措施: Mineral trioxide aggregate (dressing material) (Drug)
Melatonin
(N-acetyl-5-methoxy-tryptamine) is a pleiotropic hormone synthesized in the pineal gland that has important chronobiotic properties. there is a Melatonin drug (powder) that proved to play an essential role in the regulation of bone growth (bone regeneration) and it may promote osteoblast differentiation, and stimulates mineralized matrix formation
干预措施: Melatonin (dressing material) (Drug)
Mineral Trioxide and Melatonin
Mixture of the two materials' powders.
干预措施: Melatonin (dressing material) (Drug)
结局指标
主要结局
Radiographic assessment (using Image J software program)
时间窗: Immediately after apexogenesis procedure, after 1 month, 3 months, 6 months, 9 months and 12 months
Assessment of changes in bone density surrounding the treated teeth (Densiometric analysis)
Clinically assessment (presence or abscence)
时间窗: Immediately after apexogenesis procedure, after 1 month, 3 months, 6 months, 9 months and 12 months
changes in mucobuccal folds (swelling, redness, abscess,fistula)
Clinically assessment (Modified visual analogue scale)
时间窗: Immediately after apexogenesis procedure, after 1 month, 3 months, 6 months, 9 months and 12 months
Pain, sensitivity to percussion (scale values from 0 to 10) 0 means no pain and 10 means the worst pain with failure of the treatment.
Clinically assessment (Millar's index)
时间窗: Immediately after apexogenesis procedure, after 1 month, 3 months, 6 months, 9 months and 12 months
tooth mobility (classes I,II,III) from less mobility to higher mobility.
次要结局
未报告次要终点