Clinical Evaluation and Microbiological Assessment of Diode Laser and Chemical Disinfection in Comparison to Selective Caries Removal in Management of Patients With Deep Carious Lesions: A Clinical Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Maintaining pulp vitality
研究概览
简要总结
Objectives: To evaluate the clinical and antimicrobial effect of Diode laser and chemical disinfection in comparison to selective caries removal in management of deep carious lesions.
Methods: This study will be carried on 30 patients with an age range of 18 -50 years. The patients will be selected from the outpatient clinics in Faculty of Oral and Dental Medicine, Misr International University. All patients will be randomly divided into 3 equal groups; Control group, Diode laser application with an output power of 0.5 watt group, and Chemical disinfection group. Preoperative clinical assessment and radiographs will be performed before intervention and then the patients will receive their treatment and final restorations. Follow-up with clinical assessments will be performed after 3 and 6 months. Cone beam computed tomography will be performed at the day of intervention and after 6 months. Clinical, Microbiological and Radiographic data will be collected, tabulated and statistically analyzed to compare between the success rates of diode laser, chemical disinfection and conventional selective caries removal.
详细描述
IV. Description of research question (PICO Question or its modifications)
PICO Question:
In management of patients with deep carious lesions in permanent posterior teeth, will the use of Diode laser with an output power of 0.5 watt or chemical disinfection using 2% Chlorhexidine affect the pulp vitality compared to conventional selective caries removal without disinfection?
Patient/Problem Patients with deep carious lesions in permanent posterior teeth
Intervention 1-Diode laser disinfection and 2- Chemical disinfection using 2% Chlorhexidine
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 (Outcomes Assessor)
盲法说明
Single blinded as Outcome assessors will be blinded. Both, the participants and principal investigator cannot be blinded owing to the use of two obviously different methods, laser and chemical disinfection, or no disinfection.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient-related criteria:
- •Between 18-50 years old.
- •Gender: both male and female.
- •Patients consulting in the MIU outpatient clinic.
- •Able to tolerate necessary restorative procedures (anesthesia, cavity preparation, and restorative material placement).
- •Provide informed consent.
- •Accepts the 6 months follow-up period.
- •Tooth related criteria:
- •Permanent posterior teeth with primary deep carious lesions involving 2/3 of the entire dentin thickness with no continuity between the carious cavity and the pulp chamber, as assessed by conventional periapical radiographs.
- •Teeth are vital according to pulp-sensitivity tests.
排除标准
- •Patient-related criteria:
- •Medically compromised patients.
- •Pregnant women.
- •Allergy to any of the restorative materials, including anesthetics.
- •Uncooperative patients.
- •Tooth-related criteria:
- •Deciduous teeth.
- •Teeth with previous restorations.
- •Spontaneous pain or prolonged pain (more than 2 minutes) after sensitivity tests (cold and electrical tests).
- •Negative sensitivity tests, periapical radiolucencies and sensitivity to axial or lateral percussion before signing the consent form.
- •Teeth presenting external or internal resorption, with adverse pulpal reactions.
- •Teeth with cervical caries.
- •Teeth showing signs of periodontitis following AAP 2017 criteria.
- •Justification of Exclusions:
- •Patient-related:
- •Medically compromised patients, as they will not be able to attend multiple appointments or may require special management.
- •Pregnant women; as radiographs cannot be taken for them.
- •Allergy to any of the restorative materials, including anesthetics.
- •Uncooperative patients will not abide by the instructions or attend the appointments.
- •Tooth-related:
- •Deciduous teeth; as the study is targeting only permanent teeth.
- •Teeth with previous restorations, which may add another variable to the study (type of old restorative material, extent of recurrent caries).
- •Spontaneous pain or prolonged pain after sensitivity tests (cold and electrical tests), which would indicate irreversible pulpal damage.
- •Negative sensitivity tests, periapical radiolucencies and sensitivity to axial or lateral percussion, which would indicate pulp necrosis before signing the consent form.
- •Teeth presenting external or internal resorption, with adverse pulpal reactions, which may affect the outcome of the study.
- •Teeth with cervical caries; which can't be evaluated on periapical radiographs.
- •Teeth showing signs of periodontitis following AAP 2017 criteria, which may affect the outcome of the study.
结局指标
主要结局
Maintaining pulp vitality
时间窗: ''through study completion, an average of 6 months"
measuring device 1.Cold pulp test Binary (Success/failure) If it is +ve considered success. If it is -ve, considered failure
次要结局
- Remaining dentin density("6 months")
- Reducing microbiological count("up to 1 week")