Clinical and Three-dimensional Radiographic Evaluation of Nanohydroxyapatite Versus Biodentine Following Selective Caries Removal in Deep Carious Lesions of Permanent Teeth: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- Clinical assessment of Pulp sensibility.
研究概览
简要总结
This clinical trial aims to evaluate dentin bridge formation over the pulp following selective caries removal in permanent teeth with deep carious lesions (ICDAS scores 4-6). A total of 50 patients will be enrolled and randomly allocated to receive either nanohydroxyapatite or Biodentine as the pulp protection material. Clinical assessments and radiographic evaluations using three-dimensional imaging will be performed to measure the quality and extent of dentin bridge formation. Outcomes will be monitored and compared between baseline and 6 months, and between baseline and 12 months, to determine the effectiveness of each material in preserving pulp vitality and promoting reparative dentin formation.
详细描述
This randomized controlled clinical trial is designed to investigate the effectiveness of two bio-inductive materials-nanohydroxyapatite and Biodentine-in promoting dentin bridge formation following selective caries removal in permanent teeth with deep carious lesions (ICDAS scores 4-6).
A total of 50 patients presenting with deep caries in permanent teeth will be recruited according to specific inclusion and exclusion criteria. After selective removal of carious dentin, the cavity will be managed by applying either nanohydroxyapatite or Biodentine as the pulp protection material. Random allocation will be employed to ensure equal distribution between the two treatment groups.
Clinical assessments will include evaluation of pulp vitality and assessment of pain. Radiographic assessments will be conducted using three-dimensional imaging techniques, allowing precise evaluation of the presence, thickness, and continuity of the dentin bridge formed over the pulp.
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)
盲法说明
This is a double-blinded trial: participants and outcome assessors/analysts will be blinded to treatment allocation. The operator (E.H.) cannot be blinded due to differences in handling and placement of the two materials
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient-related criteria:
- •Adult patients (age: 18-40 years) of both genders.
- •Good oral hygiene.
- •Willing to sign the informed consent.
- •Cooperative patients who accept the follow-up period.
- •Tooth-related criteria:
- •Posterior permanent caries (ICDAS 4-6).
- •Radiographically, caries is extending 50% of dentine with a radiopaque layer between the carious lesion and the pulp chamber.
- •Sensible teeth according to the cold pulp test.
- •Negative response in percussion test.
排除标准
- •Patient-related criteria:
- •Allergy to any of the restorative materials.
- •Patients undergoing orthodontic treatment with fixed appliances.
- •Pregnant women.
- •Patients with debilitating systemic diseases.
- •Patient who frequently uses analgesics or any drugs that could mask the pain.
- •Tooth-related criteria:
- •Teeth with previous restorations.
- •Spontaneous pain or prolonged pain (more than 15 s) after the sensitivity test (cold test), which would indicate irreversible pulpitis.
- •Negative sensibility tests, periapical radiolucency, and sensitivity to axial or lateral percussion.
- •Mobile teeth, indicating periodontal disease or trauma.
- •External or internal resorption.
- •Chipped teeth or Cuspal loss
结局指标
主要结局
Clinical assessment of Pulp sensibility.
时间窗: 12 months
Electrical pulp test
次要结局
- Clinical assessment of pain.(12 months)
- Thickness and quality of Dentin bridge formation(12 months)
- Clinical assessment of pain.(12 months)
- Thickness and quality of Dentin bridge formation(12 months)
研究者
Esraa Hamdy Saber Mohamed
Assistant lecturer
Cairo University