Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Triple Antibiotic Paste (TAP) | Experimental | TAP placed as intracanal medicament following chemo-mechanical preparation; temporary restoration maintained for several weeks |
|
| Calcium Hydroxide Group | Active Comparator | Calcium Hydroxide intracanal dressing placed following chemo-mechanical preparation; sealed temporarily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Triple Antibiotic Paste | Drug | Intracanal medicament paste composed of Ciprofloxacin, Metronidazole, and Minocycline. Placed in the root canal for several weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Periapical Lesion Area | Percentage reduction in the area (mm²) of the periapical radiolucency from baseline, as measured on standardized periapical radiographs or CBCT scans. | Baseline, 3 months, 6 months, 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Periapical Bone Density Score | Improvement in a standardized bone density score or grayscale value of the periapical bone from baseline | Baseline, 3 months, 6 months, 12 months |
Not provided
Inclusion Criteria:
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
Exclusion Criteria:
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:
-
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Faiz Rahman | Contact | +923451505838 | faizr3702@gmail.com |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010485 | Periapical Periodontitis |
| ID | Term |
|---|---|
| D010483 | Periapical Diseases |
| D007571 | Jaw Diseases |
| D009057 | Stomatognathic Diseases |
| D010510 | Periodontal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D002126 | Calcium Hydroxide |
| ID | Term |
|---|---|
| D006878 | Hydroxides |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D017610 | Calcium Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Calcium Hydroxide (Ca(OH)2) | Drug | Standard intracanal medicament with high pH, used for its antibacterial and tissue-stimulating properties. Placed in the root canal for several weeks |
|
| D009059 |
| Mouth Diseases |
| D010518 | Periodontitis |
| D000838 |
| Anions |
| D007477 | Ions |
| D004573 | Electrolytes |