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

Minia University

Status: Not yet enrolling

Conditions: Postoperative Pain; Flare up; Flare Up, Symptom; Diabete Type 2

Treatments: Drug: bioceramic based intracanal medication; Drug: Calcium Hydroxide Intracanal medication

Study type: Interventional

Funder types: Other

Identifiers

NCT07071675

MU-EC Research NO.1064

Details and patient eligibility

About

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.

Enrollment: 56 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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56 participants in 2 patient groups

Calcium Hydroxide Group (GROUP I)

Experimental group

Description:

Treated using calcium hydroxide as an intracanal medicament (n=28)

Treatment:

Drug: Calcium Hydroxide Intracanal medication

Bioceramic Group (GROUP II)

Experimental group

Description:

treated using bio-ceramic based material as an intracanal medicament (n=28)

Treatment:

Drug: bioceramic based intracanal medication