A Randomized Controlled Trial Comparing the Clinical and Radiographic Success of 3Mixtatin Versus Modified 3Mix in Lesion Sterilization and Tissue Repair (LSTR) for The Treatment of Necrotic Primary Molars
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 24
- 主要终点
- Absence of pathological mobility measured by (Miller's grades)
研究概览
简要总结
This randomized clinical study aims to assess the clinical and radiographic success rate of the 3Mixtatin versus the 3Mix in LSTR in necrotic primary molars.
详细描述
Research question:
In necrotic primary molars with peri-radicular lesions and/or external root, resorption does adding Simvastatin to the triple antibiotic mix have higher clinical and radiographic success than the triple antibiotic paste solely?
Statement of the problem:
Primary teeth with necrotic pulp and extensive root resorption and/or furcal radiolucency are not uncommon scenarios that pediatric dentists are exposed to. Such clinical and radiographic presentations contraindicate the application of conventional pulpectomy treatment. Lesion Sterilization and Tissue Repair (LSTR) is an approach that has shown promising results in maintaining such teeth for up to 12 months. Primary teeth serve as a natural space maintainer, enable normal and healthy functioning of the child, and eliminate the chances for malocclusion and growth pattern disruptions. LSTR offers practitioners a promising option to save those teeth when all other treatment options seem impossible.
The Rationale for Conducting the Research:
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
This research will be a double-blinded study, where the patient (participant) and the outcome assessor will be blinded to the treatment group (to avoid detection, reporting and assessment bias).
When a patient agrees to participate in the trial, an envelope will be drawn by one of the residents present at the clinic and name, telephone number and patient's I.D. will be written on it. Those selected envelops will be opened at treatment visit after performing access cavity to choose which material should be used. Randomization and allocation concealment will be performed by the co-supervisor to avoid selection bias. The participant will not be aware of which treatment modality he will be receiving.
Principal investigator will not be blinded due to differences in preparation of the mix.
入排标准
- 年龄范围
- 4 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Pediatric patients aged 4-7 years.
- •Positive parental informed consent.
- •Restorable necrotic mandibular second primary molars with peri-radicular/furcal involvement and/or pathologic root resorption (external or internal).
- •Presence of chronic apical abscess or sinus tract or furcation radiolucency. (Thakur et al., 2021)
排除标准
- •Medically compromised children.
- •Children with known allergy to any of the components being utilized.
- •Molars near exfoliation.
- •Molars with severely resorbed roots more than two thirds indicated for extraction
- •Molars with insufficient coronal structure disabling proper coronal seal.
- •Presence of periapical or interradicular radiolucent area which could compromise the permanent tooth bud. (Shetty et al., 2020)
结局指标
主要结局
Absence of pathological mobility measured by (Miller's grades)
时间窗: at 12 months post operative
Miller's Classification * Grade I: first distinguishable sign of movement * Grade II: movement of tooth which allows crown to deviate 1mm of its normal position * Grade III shows noticeable and increased movement of tooth more than 1mm in any direction or the tooth can be depressed into the socket. A reduction in grade of mobility from preoperative baseline will be considered as success while increased mobility will be recorded as failure
Absence of post-operative pain (binary)
时间窗: at 12 months post operative
Measured by asking the patient to identify presence or absence of pain
Absence of soft tissue pathologies (binary)
时间窗: at 12 months post operative
Binary outcome measured visually by intraoral/extraoral examination
Absence of pain on percussion (binary)
时间窗: at 12 months post operative
Binary outcome measured by gentle tapping using the back of the mirror on the tooth
次要结局
- Status of radiolucency if present at the periapical or at furcation area(at 12 months post operative)
- Absence of external or internal root resorption(baseline , 6 ,12 months)
研究者
Dalia Magdy Abdel Azeem Al Shamy
Masters Student
Cairo University