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

Not Applicable

Not yet recruiting

• Conditions: Postoperative Pain; Flare Up, Symptom; Flare up; Diabete Type 2
• Interventions: Drug: Calcium Hydroxide Intracanal medication; Drug: bioceramic based intracanal medication

• Registration Number: NCT07071675
• Lead Sponsor: Minia University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-08
• Study First Submitted QC: 2025-07-16
• Last Update Submitted: 2025-07-16
• Study First Posted: 2025-07-17
• Last Update Posted: 2025-07-20
• Study Start: 2025-09-01
• Primary Completion: 2026-08-31
• Study Completion: 2026-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

• 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.

Exclusion Criteria

• Pregnant females.
• Patients with other systemic diseases in combination with diabetes mellitus.
• 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.
• Previously endodontically treated teeth.
• Teeth with sinus tract.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Calcium Hydroxide Group (GROUP I)	Calcium Hydroxide Intracanal medication	Treated using calcium hydroxide as an intracanal medicament (n=28)
Bioceramic Group (GROUP II)	bioceramic based intracanal medication	treated using bio-ceramic based material as an intracanal medicament (n=28)

Primary Outcome Measures

Name	Time	Method
postoperative pain intensity	6, 12, 24, 48, 72 hours and 7 days after the first visit to collect the postoperative pain data.	Postoperative pain is to 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 Incidence	Within 7 days post-treatment	Flare-up is assessed through asking the patient to notify the investigator if any sudden severe pain or swelling takes place.; This could require an unscheduled emergency visit or prescription of additional medication.