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NCT Number: NCT07239739

Comparing Two Medicines for Healing Jaw Bone Infections After Root Canal Treatment

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.Exclusion Criteria:

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Treatment and study plan

Triple Antibiotic paste

Drug

Intracanal medicament paste composed of Ciprofloxacin, Metronidazole, and Minocycline. Placed in the root canal for several weeks.

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

Primary outcomes

  1. Change in Periapical Lesion Area

    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.

Secondary outcomes

  1. Change in Periapical Bone Density Score

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Faiz Rahman

CONTACT

[email protected]

+923451505838

Sponsors and collaborators

Lead sponsor

Faiz ur rahman

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Nov 20, 2025
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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