Evaluation of Pain Relief and Bacterial Reduction After Using Calcium Hydroxide With Mesoporous Silica Nanoparticles as an Intracanal Medicament in Necrotic Mandibular Molars: A Randomized Controlled Clinical Trial

NCT07327996 | Active Not Recruiting DMC

• 1 other identifier: raneemICM10
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

This study compares how well different root canal medications reduce pain and bacteria after treatment of lower molar teeth with necrotic pulp. It tests whether adding mesoporous silica nanoparticles-antibacterial particles-to calcium hydroxide makes the treatment more effective. Forty-two adult patients will be randomly assigned to receive either calcium hydroxide alone, nanoparticles alone, or a mix of both for one week during root canal therapy. measure patients' pain levels after 6h,12h,24,48h and 72 hours from treatment and the number of bacteria before and after treatment to see which method gives the best results. The goal is to make root canal treatments more comfortable and successful for future patients.

Conditions

Necrotic Pulp

Keywords

postoperative pain; bacterial load

Outcome Measures

Primary Outcomes (1)

• Post-operative pain after application of different intracanal medications

  measuring Post-operative pain by Numerical rate scale and pain level will be assigned to one of 4 categorical score: none(0) - mild(1-3), severe(7-10) after 6h,12h,24,48h

  from 6 to 72 hours from the treatment

Secondary Outcomes (1)

• bacterial load change after intracanal medication

  immediately in the intervention and after 1 week

Study Arms (3)

The root canals will be filled with calcium hydroxide paste

ACTIVE COMPARATOR

using calcium hydroxide paste as intracanal medication for 1week

Procedure: Calcium Hydroxide Intracanal medication

The root canal will be filled with mesoporous silica nanoparticles paste.

ACTIVE COMPARATOR

using mesoporous silica nanoparticles paste as intracanal medication for week

Procedure: mesoporous silica nanoparticles paste

root canals will be filled with mesoporous silica nanoparticles with calcium hydroxide paste.

ACTIVE COMPARATOR

using mesoporous silica nanoparticles with calcium hydroxide paste as intracanal medication for 1week

Procedure: Calcium Hydroxide + mesoporous silica nanoparticles

Interventions

Calcium Hydroxide Intracanal medication PROCEDURE

root canals filled with calcium hydroxide paste as intracanal medication for 1week

The root canals will be filled with calcium hydroxide paste

mesoporous silica nanoparticles paste PROCEDURE

root canals filled with mesoporous silica nanoparticles for 1 week

The root canal will be filled with mesoporous silica nanoparticles paste.

Calcium Hydroxide + mesoporous silica nanoparticles PROCEDURE

Root canal filled with Intracanal medication by combination between mesoporous silica nanoparticles with calcium hydroxide paste for one week.

root canals will be filled with mesoporous silica nanoparticles with calcium hydroxide paste.

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with an age range between 18 to 40.
• No sex predilection.
• Patients with necrotic pulp.
• Patients able to sign informed consent.
• Restorable teeth.
• Positive patient's acceptance for participating in the study.
• Type III distal and mesial canal of first mandibular molar.

You may not qualify if:

• Pregnant females
• Medically compromised patients.
• Patients having analgesics before the treatment
• If antibiotics have been administrated during the past two weeks pre-operatively.
• Patients having bruxism or clenching
• Patients having sever malocclusion associated with traumatic occlusion.
• Teeth that have:
• Peri-apical radiolucency
• Root resorption.
• Pulp stones or calcifications.
• Previous endodontic treatment.

Sponsors & Collaborators

• Future University in Egypt: lead

Study Sites (1)

Future University in Egypt

Cairo, New Cairo, 11835, Egypt

Location

MeSH Terms

Conditions

Dental Pulp Necrosis; Pain, Postoperative

Interventions

Calcium Hydroxide

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Calcium Compounds; Anions; Ions; Electrolytes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: December 25, 2025
• First Posted: January 8, 2026
• Study Start: September 1, 2025
• Primary Completion: April 30, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: January 8, 2026

Record last verified: 2025-10

Locations

EG (1)