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NCT Number: NCT07075055

Impact of a New Bioceramic Based Intracanal Medication

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.

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Minia University, Faculty of Dentistry

Minya, Egypt

Location status: Recruiting

Location contact

ESSAM FAWZY MAHMOUD, Lecturer

CONTACT

[email protected]

+201002369916

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other names: Bio C-Temp

Bio C-Temp

Other

Bio C-Temp

Primary outcomes

  1. Treatment of Postoperative Pain

    Time frame: from 0 hours to 2 weeks after the procedure

    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".

Secondary outcomes

  1. Periapical Healing

    Time frame: After 6 months to 12 months

    Periapical healing will be evaluated by comparing the size of the initial lesion pre-operatively and postoperatively (after 6 and 12 months), using periapical radiographs and CBCT. This will be aggregated in percentage (%).

Study contacts

Contact information is provided by the study sponsor or research team.

Hanaa Ewas Korany Mabrouk, M.D

CONTACT

[email protected]

+201141265954

Sponsors and collaborators

Lead sponsor

Minia University

Other

Registry information

Official study title

Impact of a New Bioceramic Based Intracanal Medication on Postoperative Pain and Periapical Healing

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 20, 2025
Registry last updated
Jul 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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