ClinicalTrials.gg
RecruitingNCT07892703Updated Oct 23, 2026

Evaluation of Three Different Intra-canal Medicaments

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

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled Dec 2025, registered Oct 2026).
  • Started Dec 2025; still recruiting 10 months later.
Updated Oct 23, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
45
Allocation
Randomized
Ages
20 Years to 45 Years
Sex
All
01

Study 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

Read the detailed description

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.

02

Conditions studied

  • Periapical Healing
03

In context

Lead sponsor

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.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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. 6-Patients with old age.
  • Teeth with periodontal involvement. 8-Teeth with vertical root fractures.
  • Non-restorable teeth.
  • cases with previously initiated endodontic treatment.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
45 participants (estimated)

Study arms

  • Experimental
    Group A (Metapaste)

    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

  • Experimental
    Group B (Bio C-Temp)

    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

  • Experimental
    Group C (Triple Antibiotic Paste)

    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

  • ProcedureMetapaste 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

06

What researchers measure

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".

    Time frame: 7 Days

07

Study locations

1 of 1 sites recruiting
  • Department of Endodontics, Faculty of Dentistry Minia University
    Minya, Egypt
    Recruiting
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Dec 2025 (actual). Primary completion is estimated for Dec 2026, 11 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 18, 2026
First posted
Oct 23, 2026
StartActual
Dec 16, 2025
Primary completionEst.
Dec 10, 2026
CompletionEst.
Dec 16, 2026
Last update
Oct 23, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 23, 2026
Show all 1 update
  1. Oct 23, 2026
    First appeared on the registry

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 ↗

09

Registry details

Key details

Study ID
NCT07892703
Lead sponsor
Minia University
Responsible party
Shimaa Mohamed Abdelhamed (Researcher at department of Endodontics, Faculty of Dentistry, Minia University) — Principal investigator
First posted
Oct 23, 2026
Start date
Dec 16, 2025
Primary completion
Dec 10, 2026 (estimated)
Completion
Dec 16, 2026 (estimated)
Last update
Oct 23, 2026

Study contacts

Shimaa Mohamed Abdelhamed, MSc
Contact
drshimamarof@gmail.com
+201142155099
Dalia Ali Ahmed Moukarab, M.D
study chair · Professor and head of department of Endodontics, Faculty of Dentistry, Minia University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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