Postoperative Pain, Flare Up, Symptom, Flare up, Diabete Type 2
Conditions
Keywords
postoperative pain, flare up, diabetes type II, Intra-Canal medication, bioceramic, calcium hydroxide
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.
Interventions
Treated using calcium hydroxide based material as an intracanal medicament
treated using bio-ceramic based material as an intracanal medicament
Sponsors
Minia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Contacts
Primary ContactAbdulrahman Issam Marie
Outcome results
None listed