Evaluation of Three Different Intra-canal Medicaments

NCT07892703 | Recruiting DMC

• 1 other identifier: intra-canal medicaments
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Periapical lesions are the commonly occurring pathologic lesions that affect the periradicular tissues of the tooth . This lesion can be classified as granuloma, cystic, or abscess .The pathologic changes seen in some periradicular and periapical cases are due to the presence of microorganisms, and their byproducts. These released toxins have the ability to diffuse through inflamed pulpal tissue and get into the periapical area. In a necrotic pulp, the lack of blood flow in the root prevents host immunity from eliminating the infection

Conditions

Periapical Healing

Outcome Measures

Primary Outcomes (1)

• Post Operative Pain

  Intensity of post- operative pain level will be recorded at 6, 12, 24, 48, 72-hours and 7 days after Endodontic treatment by numerical Rating Scale using Numerical Rate Scale (NRS) and will be used to record the patients' pain levels. The NRS (0-10 scale) where as: 0 reading represents "no pain" ; 1- 3 reading represents "mild pain" ; 4- 6 reading represents "moderate pain" and 7- 10 reading represents "severe pain".

  7 Days

Study Arms (3)

Group A (Metapaste)

EXPERIMENTAL

About 15 participants will be subjected After complete preparation of the root canal system to placing the Metapaste in the canal using an amalgam carrier and packed with large endodontic pluggers. * The access cavity will be sealed with Cavit. Patients will be recalled after 2 weeks, and the tooth will be examined for postoperative pain evaluation.

Procedure: Metapaste Calcium Hydroxide

Group B (Bio C-Temp)

EXPERIMENTAL

About 15 participants will be subjected After complete preparation of the root canal system to placing the Bio C-Temp in the canal using an amalgam carrier and packed with large endodontic pluggers. -The access cavity will be sealed with Cavit. Patients will be recalled after 2 weeks, and the tooth will be examined for postoperative pain evaluation.

Procedure: Metapaste Calcium Hydroxide

Group C (Triple Antibiotic Paste)

EXPERIMENTAL

About 15 participants will be subjected After complete preparation of the root canal system to placing Triple Antibiotic Paste in the canal using an amalgam carrier and packed with large endodontic pluggers. -The access cavity will be sealed with Cavit. Patients will be recalled after 2 weeks, and the tooth will be examined for postoperative pain evaluation

Procedure: Metapaste Calcium Hydroxide

Interventions

Metapaste Calcium Hydroxide PROCEDURE

To compare between the effect of calcium hydroxide, Bio-C Temp and Triple Antibiotic Paste as intra canal medicaments on postoperative pain and healing via CBCT.

Also known as: Bio C-Temp, Triple Antibiotic

Group A (Metapaste); Group B (Bio C-Temp); Group C (Triple Antibiotic Paste)

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with mature teeth.
• Patients with periapical periodontitis.
• Maxillary anterior teeth only will be involved.
• Patients should be free from any systemic disease that may affect normal healing and predictable outcome.
• Patients who will agree to the consent and will commit to follow-up period.

You may not qualify if:

• Patients with immature roots.
• Patients with any systemic disease that may affect normal healing.
• Patients with swelling.
• Pregnant females.
• Patients who could/would not participate in a 1-year follow-up. 6-Patients with old age.
• Teeth with periodontal involvement. 8-Teeth with vertical root fractures.
• Non-restorable teeth.
• cases with previously initiated endodontic treatment.

Sponsors & Collaborators

• Minia University: lead

Study Sites (1)

Department of Endodontics, Faculty of Dentistry Minia University

Minya, Egypt

RECRUITING

MeSH Terms

Interventions

bacitracin zinc, neomycin sulfate, polymyxin B, drug combination

Study Officials

• Dalia Ali Ahmed Moukarab, M.D

  Professor and head of department of Endodontics, Faculty of Dentistry, Minia University

  STUDY CHAIR

Central Study Contacts

Shimaa Mohamed Abdelhamed, MSc

CONTACT

+201142155099; drshimamarof@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher at department of Endodontics, Faculty of Dentistry

Study Record Dates

• First Submitted: October 18, 2026
• First Posted: October 23, 2026
• Study Start: December 16, 2025
• Primary Completion (Estimated): December 10, 2026
• Study Completion (Estimated): December 16, 2026
• Last Updated: October 23, 2026

Record last verified: 2025-12

Locations

EG (1)