Effect of Triple Antibiotic Paste and Calcium Hydroxide on the Rate of Healing of Periapical Lesions in Single-Rooted Teeth: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 62
- 主要终点
- Change in Periapical Lesion Area
研究概览
简要总结
This study compares two commonly used intracanal medicaments-Triple Antibiotic Paste and Calcium Hydroxide-in patients with infected single-rooted teeth. The purpose is to determine which medicament promotes faster healing of periapical lesions after root canal treatment by measuring reduction in lesion size and improvement in bone density over 3, 6, and 12 months.
详细描述
This single-center, parallel-arm, randomized controlled trial aims to directly compare the efficacy of Triple Antibiotic Paste (TAP) and Calcium Hydroxide (CH) as intracanal medicaments on the rate of healing of periapical lesions in single-rooted teeth. Systemically healthy adults (18-65 years) with a diagnosis of pulpal necrosis and asymptomatic apical periodontitis or chronic apical abscess, presenting with a radiographically evident periapical radiolucency (≥2mm), will be enrolled. Following informed consent, chemomechanical preparation, and randomization, participants will receive either TAP (Ciprofloxacin:Metronidazole:Minocycline) or CH as the intracanal medicament. The primary outcome is the rate of healing, quantified by the percentage reduction in periapical lesion area and improvement in bone density scores assessed on standardized periapical radiographs or CBCT scans at 3, 6, and 12-month follow-ups. Secondary outcomes include clinical resolution (absence of pain, tenderness, sinus tract) and radiographic resolution (restoration of normal periapical architecture). Data will be analyzed using intention-to-treat analysis, with repeated-measures ANOVA to compare healing trajectories between groups.
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)
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Systemically healthy adult patients between 18 and 65 years of age.
- •Presence of a single-rooted tooth diagnosed with pulpal necrosis and asymptomatic apical periodontitis or chronic apical abscess.
- •Radiographic evidence of a distinct periapical radiolucency with a minimum diameter of 2mm.
- •The involved tooth must be deemed restorable after endodontic treatment.
- •Patient willingness and ability to provide informed consent and comply with the follow-up schedule
排除标准
- •Patients under 18 or over 65 years of age.
- •Presence of systemic diseases known to affect bone metabolism or immune response (e.g., uncontrolled diabetes).
- •Pregnancy or lactation.
- •Known allergies to any components of Triple Antibiotic Paste or calcium hydroxide.
- •Teeth with previous root canal treatment, internal/external root resorption, root fractures, or non-endodontic periapical pathology.Exclusion Criteria:
研究组 & 干预措施
Calcium Hydroxide Group
Calcium Hydroxide intracanal dressing placed following chemo-mechanical preparation; sealed temporarily
干预措施: Calcium Hydroxide (Ca(OH)2) (Drug)
Triple Antibiotic Paste (TAP)
TAP placed as intracanal medicament following chemo-mechanical preparation; temporary restoration maintained for several weeks
干预措施: Triple Antibiotic Paste (Drug)
Triple Antibiotic Paste (TAP)
TAP placed as intracanal medicament following chemo-mechanical preparation; temporary restoration maintained for several weeks
干预措施: Calcium Hydroxide (Ca(OH)2) (Drug)
Calcium Hydroxide Group
Calcium Hydroxide intracanal dressing placed following chemo-mechanical preparation; sealed temporarily
干预措施: Triple Antibiotic Paste (Drug)
结局指标
主要结局
Change in Periapical Lesion Area
时间窗: Baseline, 3 months, 6 months, 12 months
Percentage reduction in the area (mm²) of the periapical radiolucency from baseline, as measured on standardized periapical radiographs or CBCT scans.
次要结局
- Change in Periapical Bone Density Score(Baseline, 3 months, 6 months, 12 months)
研究者
Faiz ur rahman
Postgraduate Resident, Department of Operative Dentistry
College of Physicians and Surgeons Pakistan
