Comparison of Effectiveness of Biodentine Versus Calcium Hydroxide as Indirect Pulp Capping Material in Mature Permanent Teeth
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- Radiographic assessment by Periapical Index (PAI)
研究概览
简要总结
This study compares the clinical and radiographic effectiveness of Biodentine and Calcium Hydroxide as indirect pulp capping materials in mature permanent teeth with reversible pulpitis. A total of 76 patients were randomly assigned to two groups. Outcomes were assessed over 12 weeks based on pain, periapical radiolucency, and PDL widening. The goal was to determine which material better preserves pulp vitality
详细描述
Introduction:
Preservation of pulp vitality is critical for the long-term health and functionality of teeth. The pulp can be compromised due to caries, trauma, or iatrogenic factors. One conservative treatment to preserve pulp vitality in teeth with deep carious lesions and reversible pulpitis is indirect pulp capping (IPC).
Traditionally, Calcium Hydroxide (Ca(OH)₂) has been the gold standard material for IPC due to its antibacterial properties and its ability to stimulate the formation of reparative dentin. However, it has several limitations such as poor bonding to dentin, high solubility, and low mechanical strength, which may affect long-term success.
Biodentine, a newer bioactive dentin substitute, has emerged as a potential alternative due to its biocompatibility, bioactivity, antibacterial effect, good sealing ability, and high compressive strength. These properties suggest Biodentine may offer superior clinical outcomes in preserving pulp vitality when used as an indirect pulp capping material.
Objective:
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
- 20 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must meet all of the following criteria to be included in the study:
- •Age: 20 to 45 years.
- •Tooth Type: Mature permanent teeth (maxillary or mandibular).
- •Caries Status: Occlusal carious lesions without previous restorations.
- •Pulpal Diagnosis: Reversible pulpitis confirmed by:
- •Patient history and clinical examination
- •Positive response to thermal (cold) and electric pulp tests
- •No tenderness to percussion
- •Radiographic Assessment: Carious lesion corresponding to ICDAS radiographic score RC-
- •Periapical Status: No signs of periapical radiolucency or root resorption on radiograph.
排除标准
- •Participants will be excluded if they meet any of the following:
- •Teeth exhibiting signs of irreversible pulpitis or pulp necrosis.
- •Tenderness to percussion on clinical examination.
- •Pulp exposure during caries removal.
- •Systemic conditions that may interfere with healing or immune response, including:
- •Chronic systemic illness
- •Immunocompromised status
- •Third molars (due to anatomical and treatment variability)
结局指标
主要结局
Radiographic assessment by Periapical Index (PAI)
时间窗: Follow-up Timeline for Each Patient: Patients will be evaluated at the following intervals after the indirect pulp capping procedure: Baseline (Initial Treatment) 2 weeks follow-up 6 weeks follow-up 12 weeks follow-up
PAI Scoring Criteria: Score Radiographic Features Interpretation 1. Normal periapical structures Healthy PDL and periapical tissues 2. Small changes in bone structure (slight PDL widening) Mild changes; potentially reversible 3. Changes in bone structure with mineral loss Moderate periapical inflammation 4. Well-defined radiolucent area Established periapical periodontitis 5. Severe radiolucency with bone destruction Advanced periapical disease Application in my Study: At each follow-up (2, 6, 12 weeks), periapical radiographs should be: Evaluated using the PAI score Compared to baseline radiographs Scores ≤2 are generally considered favorable outcomes Scores ≥3 indicate disease or failure
Visual Analog Scale (VAS) for Pain Measurement
时间窗: Patients pain level can be measured on the scale at: Baseline 2-week 6-week 12-week follow-up visits
1\. Pain Assessment Type: Spontaneous or provoked Tool: Patient history and Visual Analog Scale (VAS) for Pain Measurement Classification: No pain Mild/transient pain (indicative of successful pulp healing) Moderate to severe pain (suggestive of pulpal inflammation or failure) Interpretation: Absence of pain considered a positive outcome. Persistent or worsening pain may indicate treatment failure or progression to irreversible pulpitis Visual Analog Scale (VAS) for Pain Measurement Description: A 10 cm horizontal line representing a continuum of pain intensity. One end (0 cm) represents "No pain", and the other end (10 cm) represents "Worst possible pain". Scoring Criteria: VAS Score (cm) Pain Intensity 0 No pain 1-3 Mild pain 4-6 Moderate pain 7-10 Severe pain Application in my Study: Patients can be asked to mark their pain level on the scale at: Baseline 2-week 6-week 12-week follow-up visits
Tenderness to Percussion
时间窗: Patients tenderness to percussion will be checked at: Baseline 2-week 6-week 12-week follow-up visits
2\. Tenderness to Percussion Tool: Blunt end of dental mirror gently tapped on the occlusal surface Response Categories: Absent: No discomfort or pain on percussion (favorable response) Present: Pain on percussion, indicating potential periapical inflammation or pulp degeneration Interpretation: Lack of tenderness is a favorable clinical outcome. Positive percussion response may suggest underlying periapical involvement or pulpal pathology.
Pulp Vitality Testing : Cold test (Endo-Ice or refrigerant spray on cotton pellet) and Electric Pulp Test (EPT)
时间窗: Patients tooth vitality testing will be done at: Baseline 2-week 6-week 12-week follow-up visit
Pulp Vitality Testing Methods Used: Cold test (Endo-Ice or refrigerant spray on cotton pellet) Electric Pulp Test (EPT) Response Categories: Normal response: Short, sharp, non-lingering sensation (indicative of vital pulp) Exaggerated or lingering pain: Suggestive of reversible/irreversible pulpitis No response: Indicative of non-vital or necrotic pulp Interpretation: A normal response to cold or EPT at follow-up implies successful preservation of pulp vitality. No response or lingering pain may indicate pulp necrosis or treatment failure
次要结局
未报告次要终点
研究者
Zahoor khan
Dr Zahoor khan, Resident operative dentistry & endodontics, HITECIMS taxila pakistan
HITEC-Institute of Medical Sciences