Postoperative Pain and Flare-Up Rates in Diabetic Type II Patients Following The Use of Bioceramic Intracanal Medication
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Calcium Hydroxide Intracanal medication, bioceramic based intracanal medication.
- Who it may be relevant to
- Registry conditions: Postoperative Pain, Flare Up, Symptom, Flare up, Diabete Type 2. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official 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)
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.
Interventions
- Drug Calcium Hydroxide Intracanal medication
Treated using calcium hydroxide based material as an intracanal medicament - Drug bioceramic based intracanal medication
treated using bio-ceramic based material as an intracanal medicament
Primary outcome measures
- postoperative pain intensity [Time frame: 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07071675 · MU-EC Research NO.1064