An interventional study of Metapaste Calcium Hydroxide in Periapical Healing, sponsored by Minia University. Recruiting at 1 site in Egypt. Open to participants aged 20 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by Minia University · Not applicable, Interventional, and Treatment
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
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.
Favourable outcome is due to:
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.
Triple-Antibiotic Paste [TAP] has been recommended for intra-canal disinfection, TAP has been shown to be the most effective. TAP, a mix of three different antibiotics, provides effective action against different microorganisms and produces outstanding results. The combined action of three different antibiotics also helps reduce the chances of microbial resistance. As there are several advantages and disadvantages associated with the different antimicrobial agents available, the selection of the best is essential.
Minia University is the lead sponsor of 368 studies on the registry; 117 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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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
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
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
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
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".
Time frame: 7 Days
Started Dec 2025 (actual). Primary completion is estimated for Dec 2026, 11 months after the start.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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