Triple Antibiotic paste
DrugIntracanal medicament paste composed of Ciprofloxacin, Metronidazole, and Minocycline. Placed in the root canal for several weeks.
NCT Number: NCT07239739
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.
Trial opening soon.
Get Notified18 year–65 year
All sexes
Interventional
Not applicable
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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:
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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
Time frame: 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.
Time frame: Baseline, 3 months, 6 months, 12 months
Improvement in a standardized bone density score or grayscale value of the periapical bone from baseline
Contact information is provided by the study sponsor or research team.
Faiz ur rahman
Other
Effect of Triple Antibiotic Paste and Calcium Hydroxide on the Rate of Healing of Periapical Lesions in Single-Rooted Teeth: A Randomized Controlled Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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