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

N/ANot Yet RecruitingNCT07071675

Minia University56 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Postoperative Pain Flare Up, Symptom

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: Within 7 days post-treatment