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

NCT07239739 | Not Yet Recruiting

• 1 other identifier: SCD-Endo-001
• Study Type: interventional
• Target: 62
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Periapical Lesion; Periapical Periodontitis

Keywords

Triple Antibiotic Paste,; Calcium Hydroxide,; Periapical Healing; Intracanal Medicament

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Change in Periapical Bone Density Score

  Baseline, 3 months, 6 months, 12 months

Study Arms (2)

Triple Antibiotic Paste (TAP)

EXPERIMENTAL

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

Drug: Triple Antibiotic Paste; Drug: Calcium Hydroxide (Ca(OH)2)

Calcium Hydroxide Group

ACTIVE COMPARATOR

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

Drug: Triple Antibiotic Paste; Drug: Calcium Hydroxide (Ca(OH)2)

Interventions

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

Calcium Hydroxide Group; Triple Antibiotic Paste (TAP)

Triple Antibiotic Paste DRUG

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

Calcium Hydroxide Group; Triple Antibiotic Paste (TAP)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Faiz ur rahman: lead

MeSH Terms

Conditions

Periapical Periodontitis

Interventions

Calcium Hydroxide

Condition Hierarchy (Ancestors)

Periapical Diseases; Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Calcium Compounds; Anions; Ions; Electrolytes

Central Study Contacts

Faiz Rahman

CONTACT

+923451505838; faizr3702@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Postgraduate Resident, Department of Operative Dentistry

Study Record Dates

• First Submitted: November 16, 2025
• First Posted: November 20, 2025
• Study Start (Estimated): June 15, 2026
• Primary Completion (Estimated): November 15, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share