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

NCT07071675 | Not Yet Recruiting DMC

• 1 other identifier: MU-EC Research NO.1064
• Study Type: interventional
• Target: 56
• Locations: 0 countries
• Sites: N/A

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:

• 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.

Conditions

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

Keywords

postoperative pain; flare up; diabetes type II; Intra-Canal medication; bioceramic; calcium hydroxide

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Calcium Hydroxide Group (GROUP I)

EXPERIMENTAL

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

Drug: Calcium Hydroxide Intracanal medication

Bioceramic Group (GROUP II)

EXPERIMENTAL

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

Drug: bioceramic based intracanal medication

Interventions

Calcium Hydroxide Intracanal medication DRUG

Treated using calcium hydroxide based material as an intracanal medicament

Calcium Hydroxide Group (GROUP I)

bioceramic based intracanal medication DRUG

treated using bio-ceramic based material as an intracanal medicament

Bioceramic Group (GROUP II)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Minia University: lead

MeSH Terms

Conditions

Pain, Postoperative; Symptom Flare Up; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Recurrence; Disease Attributes; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Abdulrahman Issam Marie

CONTACT

+201069060274; mr.marie98@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postgraduate Student, Department of Endodontics

Model Details: 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.

Study Record Dates

• First Submitted: July 8, 2025
• First Posted: July 17, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: July 20, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share