Impact of a New Bioceramic Based Intracanal Medication

NCT ID: NCT07075055

Last Updated: 2025-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-01

Study Completion Date

2026-07-10

Brief Summary

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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.

Detailed Description

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Endodontic treatment is essentially directed towards the prevention and control of pulpal and periradicular infections. Complete chemomechanical preparation may be considered an essential step in root canal disinfection. However total elimination of bacteria is difficult to accomplish. by remaining in the root canal between appointments, intracanal medicament may help to eliminate bacteria.

A medicament is an antimicrobial agent that is placed inside the root canal between treatment appointments in an attempt to destroy remaining microorganisms and prevent reinfection Thus, they may be utilized to kill bacteria, reduce inflammation (and thereby reduce pain), help eliminate apical exudate, control inflammatory root resorption and prevent contamination between appointments.When intracanal medicaments were not used between appointments, bacterial numbers increased rapidly.

The BIO-C® TEM has emerged as the first intracanal bioceramic medication of Endodontics, indicated for cases of treatment and retreatment due to its high pH to its antibacterial, bacteriostatic, anti- inflammatory and mineralization- -inducing action. Since it is a bioactive product, BIO-C® TEMP interacts with the surrounding tissue, stimulating healing. The tissue system responds to the material as if it was a natural tissue.

It has found its way in treatment of diverse cases: pulpitis, pulp necrosis, periapical lesion, persistent fistula, inflammatory or purulent exudate, perforation, apexification, external and internal resorption. It has been recommended not only for its actions, but also because it is a ready-to-use syringe, easy to insert into the root canal and with no painful symptomatology, even in cases where it has been extruded through the apical foramen.

Gradual release of Ca2+ Periodic exchange is not required, Biocompatible( Absence of symptomatology), High alkalinity (pH \~12)( Unsuitable environment for bacterial growth), Easy to remove( Clinical time optimization),and High radiopacity (Excellent radiographic visualization).

The intra-canal procedures based on the maximum elimination of the irritant including antimicrobial intra-canal dressing are valuable tool to control endodontic infections and theoretically prevent postoperative pain.

Periapical lesions, inflammatory reactions caused by bacterial infections in the periapical area of teeth, require effective treatment for optimal healing.For decades non-setting Ca(OH)2 has been the gold standard intracanal medicament in endodontic procedures to promote the healing of periapical lesions.

Conditions

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Post Operative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Metapaste Calcium Hydroxide

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.

Group Type ACTIVE_COMPARATOR

Metapaste Calcium Hydroxide

Intervention Type 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

Bio C-Temp

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.

Group Type ACTIVE_COMPARATOR

Bio C-Temp

Intervention Type OTHER

Bio C-Temp

Interventions

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Metapaste Calcium Hydroxide

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

Intervention Type OTHER

Bio C-Temp

Bio C-Temp

Intervention Type OTHER

Other Intervention Names

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Bio C-Temp

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Minia University

OTHER

Sponsor Role lead

Responsible Party

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Hanaa Ewas Korany Mabrouk

Assistant lecturer of Endodontics at Nahda University,

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wael HUESSIEN KAMEL, Professor

Role: STUDY_CHAIR

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

Locations

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Minia University, Faculty of Dentistry

Minya, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Hanaa Ewas Korany Mabrouk, M.D

Role: CONTACT

+201141265954

Facility Contacts

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ESSAM FAWZY MAHMOUD, Lecturer

Role: primary

+201002369916

Other Identifiers

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Intracanal Bioceramic

Identifier Type: -

Identifier Source: org_study_id

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