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NCT Number: NCT07071675

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

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.

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Key information

Conditions

Postoperative Pain Diabete Type 2 Diabetes Mellitus Diabetes Mellitus, Type 2 Disease Attributes Endocrine System Diseases Flare Up, Symptom Flare up Glucose Metabolism Disorders Metabolic Diseases Neurologic Manifestations Nutritional and Metabolic Diseases Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Recurrence Signs and Symptoms Symptom Flare Up

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Calcium Hydroxide Intracanal medication

Drug

Treated using calcium hydroxide based material as an intracanal medicament

bioceramic based intracanal medication

Drug

treated using bio-ceramic based material as an intracanal medicament

Primary outcomes

postoperative pain intensity

Time frame: 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

Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Abdulrahman Issam Marie

CONTACT

[email protected]

+201069060274

Sponsors and collaborators

Lead sponsor

Minia University

Other

Registry information

Official study title

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)

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Jul 17, 2025
Registry last updated: Jul 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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