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

NCT ID: NCT07239739

Last Updated: 2025-11-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-15
• Study Completion Date: 2026-06-15

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.

Conditions

Periapical Lesion; Periapical Periodontitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Triple Antibiotic Paste (TAP)

TAP placed as intracanal medicament following chemo-mechanical preparation; temporary restoration maintained for several weeks

Group Type: EXPERIMENTAL

Triple Antibiotic Paste

Intervention Type: DRUG

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

Calcium Hydroxide (Ca(OH)2)

Intervention Type: DRUG

Standard intracanal medicament with high pH, used for its antibacterial and tissue-stimulating properties. Placed in the root canal for several weeks

Calcium Hydroxide Group

Calcium Hydroxide intracanal dressing placed following chemo-mechanical preparation; sealed temporarily

Group Type: ACTIVE_COMPARATOR

Triple Antibiotic Paste

Intervention Type: DRUG

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

Calcium Hydroxide (Ca(OH)2)

Intervention Type: DRUG

Standard intracanal medicament with high pH, used for its antibacterial and tissue-stimulating properties. Placed in the root canal for several weeks

Interventions

Triple Antibiotic Paste

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

Intervention Type: DRUG

Calcium Hydroxide (Ca(OH)2)

Standard intracanal medicament with high pH, used for its antibacterial and tissue-stimulating properties. Placed in the root canal for several weeks

Intervention Type: DRUG

Eligibility Criteria

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.

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• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Faiz ur rahman

OTHER

Sponsor Role: lead

Responsible Party

Faiz ur rahman

Postgraduate Resident, Department of Operative Dentistry

Responsibility Role: SPONSOR_INVESTIGATOR

Central Contacts

Faiz Rahman

Role: CONTACT

faizr3702@gmail.com

+923451505838

Other Identifiers

SCD-Endo-001

Identifier Type: -

Identifier Source: org_study_id