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NCT07071675Not yet recruiting

Postoperative Pain and Flare-Up Rates in Diabetic Type II Patients Following The Use of Bioceramic Intracanal Medication

Postoperative Pain and Flare-Up Incidence Following the Use of Bio Ceramic Based Intra-Canal Medication in Diabetic Type II Patients (A Randomized Clinical Trial)

Source: ClinicalTrials.gov · Last updated 20 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

The goal of this randomized clinical trial is to evaluate the Postoperative Pain and Flare-Up incidence following the use of Bio-Ceramic Based Intra-Canal Medication in Diabetic type II Patients compared to the Calcium Hydroxide based Intra-canal medicament. The main questions it aims to answer are: 1. Is there any difference between using the two intracanal medicaments in the aspects of postoperative pain and flare-up incidence in diabetic type II patients? 2. Do intracanal medications reduce postoperative pain and flare-up incidence in diabetic type II patients? Participants will be divided into two groups: ( both groups will receive root canal treatment in single rooted teeth) then: First group: will receive "Calcium Hydroxide based" intracanal medicament Second group: will receive "Bio-Ceramic Based" intracanal medicament Postoperative pain will be assessed using: * visual analog scale (VAS), A scale from (0 to 10) where "0" means no pain and "10" means a severe pain that has never faced before. * Patients will be contacted by phone at 6, 12, 24, 48, 72 hours and 7 days after the first visit to collect the postoperative pain data. Flare-up is assessed: \- by asking the patient to notify the investigator if any sudden severe pain or swelling takes place.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
56 (estimated)
First submitted
8 Jul 2025
Start date
1 Sept 2025
Primary completion date
31 Aug 2026
Lead sponsor
Minia University
NCT number
NCT07071675

What you commit to

  • Study type: Interventional
  • Planned participants: 56
  • From 1 Sept 2025 to the primary completion date, 31 Aug 2026
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previously endodontically treated teeth.

Other illness

  • Patients with other systemic diseases in combination with diabetes mellitus.

Other

  • Pregnant females.
  • Patients under antibiotic or analgesic administration.
  • Patients with facial swelling.
  • Teeth that are not indicated for endodontic treatment: bad oral hygiene, mobile teeth, or recessed teeth.
  • Teeth with sinus tract.

Who the study is looking for

  • Patients with controlled diabetes mellitus type II.
  • Necrotic single rooted teeth:
    • with periapical lesion ranging (1-2mm) in diameter.
    • with complete root formation.
    • Without calcified root canals.
    • Without root caries.
    • Without external or internal root resorption.
    • Without anatomical abnormalities such as fusion.

Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.