Periapical Lesion, Periapical Periodontitis
Conditions
Keywords
Triple Antibiotic Paste,, Calcium Hydroxide,, Periapical Healing, Intracanal Medicament
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.
Interventions
Intracanal medicament paste composed of Ciprofloxacin, Metronidazole, and Minocycline. Placed in the root canal for several weeks.
Standard intracanal medicament with high pH, used for its antibacterial and tissue-stimulating properties. Placed in the root canal for several weeks
Sponsors
Faiz ur rahman
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Contacts
CONTACTFaiz Rahman
Outcome results
None listed