Impact of a New Bioceramic Based Intracanal Medication

NCT07075055 | Recruiting DMC

• 1 other identifier: Intracanal Bioceramic
• Study Type: interventional
• Target: 26
• 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 pathological 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

Post Operative Pain

Outcome Measures

Primary Outcomes (1)

• Treatment of Postoperative Pain

  Patients will be evaluated for postoperative pain via (NRS) to record the intensity of pain.as follows: 0 reading represents "no pain" ; 1- 3 reading represents "mild pain" ; 4- 6 reading represents "moderate pain" and 7- 10 reading represents "severe pain".

  from 0 hours to 2 weeks after the procedure

Secondary Outcomes (1)

• Periapical Healing

  After 6 months to 12 months

Study Arms (2)

Metapaste Calcium Hydroxide

ACTIVE COMPARATOR

About 13 healthy patients of both genders presented with periapical radiolucency will subject to complete preparation of the root canal system using the (Metapaste Calcium Hydroxide(Pre-mixed paste) as an intracanal medicament.

Other: Metapaste Calcium Hydroxide

Bio C-Temp

ACTIVE COMPARATOR

About 13 healthy patients of both genders presented with periapical radiolucency will subject to complete preparation of the root canal system using the (Bio C-Temp) as an intracanal medicament.

Other: Bio C-Temp

Interventions

Metapaste Calcium Hydroxide OTHER

To compare the effect of calcium hydroxide and Bio-C Temp as intra canal medications on postoperative pain via VAS and periapical healing via CBCT

Also known as: Bio C-Temp

Metapaste Calcium Hydroxide

Bio C-Temp OTHER

Bio C-Temp

Bio C-Temp

Eligibility Criteria

• Age: 18 Years - 40 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.
• Patients with old age.
• Teeth with periodontal involvement.
• Teeth with vertical root fractures.
• Non-restorable teeth.
• Cases with previously initiated endodontic treatment.

Sponsors & Collaborators

• Minia University: lead

Study Sites (1)

Minia University, Faculty of Dentistry

Minya, Egypt

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Wael HUESSIEN KAMEL, Professor

  Department of Endodontics, Faculty of Dentistry,Al-Azhar University

  STUDY CHAIR

Central Study Contacts

Hanaa Ewas Korany Mabrouk, M.D

CONTACT

+201141265954; Dentist77789@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: Assistant lecturer of Endodontics at Nahda University,

Study Record Dates

• First Submitted: July 2, 2025
• First Posted: July 20, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 10, 2026
• Last Updated: July 20, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)