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临床试验/NCT07239739
NCT07239739尚未招募不适用

Effect of Triple Antibiotic Paste and Calcium Hydroxide on the Rate of Healing of Periapical Lesions in Single-Rooted Teeth: A Randomized Controlled Trial

Faiz ur rahman0 个研究点目标入组 62 人开始时间: 2026年6月15日最近更新:
干预措施

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

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

Active Comparator

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)

Experimental

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)

Experimental

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

Active Comparator

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

发起方
Faiz ur rahman
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Faiz ur rahman

Postgraduate Resident, Department of Operative Dentistry

College of Physicians and Surgeons Pakistan

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