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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:
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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Calcium Hydroxide Group (GROUP I) | Experimental | Treated using calcium hydroxide as an intracanal medicament (n=28) |
|
| Bioceramic Group (GROUP II) | Experimental | treated using bio-ceramic based material as an intracanal medicament (n=28) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Calcium Hydroxide Intracanal medication | Drug | Treated using calcium hydroxide based material as an intracanal medicament |
|
| Measure | Description | Time Frame |
|---|---|---|
| postoperative pain intensity | 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. | 6, 12, 24, 48, 72 hours and 7 days after the first visit to collect the postoperative pain data. |
| Flare-Up Incidence | 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. | Within 7 days post-treatment |
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Inclusion Criteria:
Patients with controlled diabetes mellitus type II.
Necrotic single rooted teeth:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Abdulrahman Issam Marie | Contact | +201069060274 | mr.marie98@gmail.com |
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Individual Participant Data (IPD) will not be shared due to privacy concerns and the limited scope of data use approved by the ethics committee. The study is designed for internal analysis only and does not include provisions for public data sharing.
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Participants will be randomly assigned to one of two parallel groups. Each group will receive a different intracanal medicament following root canal treatment. Postoperative pain and flare-up incidence will be assessed and compared between the two groups.
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Participants will be blinded to the type of intracanal medicament used during their root canal treatment. The medicaments will be applied in a manner that prevents participants from identifying which treatment they received.
| bioceramic based intracanal medication | Drug | treated using bio-ceramic based material as an intracanal medicament |
|
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D000067251 | Symptom Flare Up |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D012008 | Recurrence |
| D020969 | Disease Attributes |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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