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Periapical HealingNCT07892703

Evaluation of Three Different Intra-canal Medicaments

A study testing Metapaste Calcium Hydroxide in people with Periapical Healing, run by Minia University at 1 site in Egypt.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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Trial 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. Read more about this study

Who is it for?
Ages 20 to 45 years
Conditions the study is for
Periapical Healing
What is being tested?
Metapaste Calcium Hydroxide
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
1 siteEgypt
Study dates
16 Dec 2025to 16 Dec 2026
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 45 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Shimaa Mohamed Abdelhamed, MSc contact

+201142155099

drshimamarof@gmail.com

Egypt1 site, 1 recruiting
  • Department of Endodontics, Faculty of Dentistry Minia University

    Minya

    Dalia Ali Ahmed Moukarab, M.D, +201068121523, dalia.mokarab@mu.edu.eg

    Nourhan Ali Abdelhaleem, M.D, +201000188224, norhan.ali@mu.edu.eg

    Recruiting

Other trials in Egypt

About this study

Official title: Evaluation of Three Different Intra-canal Medicaments on Postoperative Pain and Periapical Healing: Randomized Clinical Trial

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.

Being tested
Metapaste Calcium Hydroxide

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Metapaste Calcium HydroxideProcedure or surgery

    Also called Bio C-Temp, Triple Antibiotic

    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.

Study groups in NCT07892703
Study groupRoleWhat they receive
Group A (Metapaste)ExperimentalAbout 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.
Receives: Procedure: Metapaste Calcium Hydroxide
Group B (Bio C-Temp)ExperimentalAbout 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.
Receives: Procedure: Metapaste Calcium Hydroxide
Group C (Triple Antibiotic Paste)ExperimentalAbout 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
Receives: Procedure: Metapaste Calcium Hydroxide

What is being measured

The primary outcome is the main question the study is designed to answer.

  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".

    Measured: 7 Days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Oct 2026
  2. Study start16 Dec 2025
  3. Primary completion10 Dec 2026 (estimated)
  4. Study completion16 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
45 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07892703
Sponsor's protocol ID
intra-canal medicaments
Status last verified
Dec 2025
First submitted
18 Oct 2026
Last updated
23 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

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