Comparing Two Medicines for Healing Jaw Bone Infections After Root Canal Treatment
- Conditions
- Periapical PeriodontitisPeriapical Lesion
- Interventions
- Registration Number
- NCT07239739
- Lead Sponsor
- Faiz ur rahman
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 62
- 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
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:
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Triple Antibiotic Paste (TAP) Triple Antibiotic Paste TAP placed as intracanal medicament following chemo-mechanical preparation; temporary restoration maintained for several weeks Calcium Hydroxide Group Calcium Hydroxide (Ca(OH)2) Calcium Hydroxide intracanal dressing placed following chemo-mechanical preparation; sealed temporarily Triple Antibiotic Paste (TAP) Calcium Hydroxide (Ca(OH)2) TAP placed as intracanal medicament following chemo-mechanical preparation; temporary restoration maintained for several weeks Calcium Hydroxide Group Triple Antibiotic Paste Calcium Hydroxide intracanal dressing placed following chemo-mechanical preparation; sealed temporarily
- Primary Outcome Measures
Name Time Method Change in Periapical Lesion Area 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.
- Secondary Outcome Measures
Name Time Method Change in Periapical Bone Density Score Baseline, 3 months, 6 months, 12 months Improvement in a standardized bone density score or grayscale value of the periapical bone from baseline