Postoperative Pain and Flare-Up Rates in Diabetic Type II Patients Following The Use of Biocerami… (NCT07071675) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Postoperative Pain and Flare-Up Rates in Diabetic Type II Patients Following The Use of Bioceramic Intracanal Medication
56 participantsStarted 2025-09-01
Plain-language 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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
postoperative pain intensity
Timeframe: 6, 12, 24, 48, 72 hours and 7 days after the first visit to collect the postoperative pain data.