Clinical and Radiographic Evaluation of Hyaluronic Acid Compared to Propylene Glycol as Vehicle for Double Antibiotic Paste in Lesion Sterilization and Tissue Repair Technique for Non-Vital Primary Molars (Randomized Clinical Trial and In Vitro Study)
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 36
- 主要终点
- Number of participants with treatment-related adverse events as assessed by clinical examination
研究概览
简要总结
Lesion sterilization and tissue repair therapy technique will be used in primary molars with root resorption using Hyaluronic acid as a vehicle for the double antibiotic therapy in comparison to the conventional technique using propylene glycol vehicle
详细描述
Clinical and Radiographic Evaluation of Hyaluronic Acid Compared to Propylene Glycol as Vehicle for Double Antibiotic paste in Lesion Sterilization and Tissue Repair Technique for Non-Vital Primary Molars(Randomized Clinical Trial and In Vitro Study) Introduction LSTR is an acronym for lesion sterilization and tissue repair. It is a process which allows the use of a combination of antibiotics (metronidazole, ciprofloxacin, and minocycline) mixed with propylene glycol gel as a vehicle for controlling of oral infections such as dentinal, pulpal, and periapical lesions. This therapy aims to eliminate causative bacteria from the diseases by disinfecting the lesions and promoting tissue regeneration by the host's natural tissue recovering process. Three types of antibiotics are combined to ensure complete removal of all pathogenic microorganisms in pulpal and periapical lesions.
Hyaluronic acid (HA) is a key element in the soft periodontal tissues, gingiva, and periodontal ligament, and in the hard tissue, such as alveolar bone and cementum Based on the multifunctional roles that HA has in wound healing generally, and that gingival and bone healing follow similar biological principles, it is conceivable that HA has comparable roles in the healing of the mineralized and nonmineralized tissues of the periodontium.
Hence, the purpose of this study is to compare the clinical and radiographic success of a hyaluronic acid and propylene glycol as vehicles for antibiotic in LSTR in primary molars.
Aim of Study A) Primary Objective • The aim of the present study is to evaluate the clinical and radiographic success of hyaluronic acid compared to propylene glycol as vehicles for antibiotics in LSTR for non-vital primary molars.
B) Secondary Objectives
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
- 5 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients who have a Primary molar with non-vital pulp.
- •Adequate restorable tooth structure for further placement of stainless-steel crowns posttreatment.
- •Inflammatory root resorption less than one half as assessed from radiographic evaluation with healthy contralateral tooth
- •Teeth showing furcation radiolucency without involving the underlying tooth germ.
排除标准
- •Primary molars with pulpal floor perforation.
- •Patients with a history of drug allergy to metronidazole, ciprofloxacin.
- •Inflammatory root resorption more than one half as assessed from radiographic evaluation with healthy contralateral tooth.
研究组 & 干预措施
hyaluronic acid group
study group
干预措施: Hyaluronic acid (Drug)
propylene glycol group
control group
干预措施: Propylene glycol (Drug)
结局指标
主要结局
Number of participants with treatment-related adverse events as assessed by clinical examination
时间窗: one year
no pain no abnormal mobility no swelling
radiographic outcome assessed by comparing pre and post treatment periapical radiolucency siz
时间窗: one year
Decrease in interarticular radiolucency in size as compared to pre operative radiolucency present before treatment
次要结局
未报告次要终点
研究者
radwa elshakhs
assisting teacher
Ain Shams University