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

Evaluation of Post-operative Pain and Bacterial Load Reduction After Incorporation of Mesoporous Silica Nanoparticles in Calcium Hydroxide Intracanal Medicament in Mandibular First Molar Teeth With Necrotic Pulp. "Randomized Controlled Clinical Trial"

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Necrotic Pulp
• Intervention / Treatment: Procedure: Calcium Hydroxide Intracanal medication; Procedure: mesoporous silica nanoparticles paste; Procedure: Calcium Hydroxide + mesoporous silica nanoparticles

• Study Type: Interventional
• Enrollment (Estimated): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • New Cairo
    • Cairo, New Cairo, Egypt, 11835
      • Future University in Egypt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

• Inclusion Criteria:

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

• Exclusion Criteria:

  1. Pregnant females
  2. Medically compromised patients.
  3. Patients having analgesics before the treatment
  4. If antibiotics have been administrated during the past two weeks pre-operatively.
  5. Patients having bruxism or clenching
  6. Patients having sever malocclusion associated with traumatic occlusion.

  7. Teeth that have:

     1. Peri-apical radiolucency
     2. Root resorption.
     3. Pulp stones or calcifications.
     4. Previous endodontic treatment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: The root canals will be filled with calcium hydroxide paste; using calcium hydroxide paste as intracanal medication for 1week	Procedure: Calcium Hydroxide Intracanal medication; root canals filled with calcium hydroxide paste as intracanal medication for 1week
Active Comparator: The root canal will be filled with mesoporous silica nanoparticles paste.; using mesoporous silica nanoparticles paste as intracanal medication for week	Procedure: mesoporous silica nanoparticles paste; root canals filled with mesoporous silica nanoparticles for 1 week
Active Comparator: root canals will be filled with mesoporous silica nanoparticles with calcium hydroxide paste.; using mesoporous silica nanoparticles with calcium hydroxide paste as intracanal medication for 1week	Procedure: Calcium Hydroxide + mesoporous silica nanoparticles; Root canal filled with Intracanal medication by combination between mesoporous silica nanoparticles with calcium hydroxide paste for one week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
bacterial load change after intracanal medication	Recording the percentage of bacterial load reduction by collecting samples by paper points, first sample after access cavity and before RCT, second sample after mechanical instrumentation, third sample after removing intracanal medication from the canal	immediately in the intervention and after 1 week

Collaborators and Investigators

• Sponsor: Future University in Egypt

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2025
• Primary Completion (Estimated): April 30, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: December 25, 2025
• First Submitted That Met QC Criteria: December 25, 2025
• First Posted (Actual): January 8, 2026

Study Record Updates

• Last Update Posted (Actual): January 8, 2026
• Last Update Submitted That Met QC Criteria: December 25, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: postoperative pain; bacterial load
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Stomatognathic Diseases; Postoperative Complications; Pathologic Processes; Dental Pulp Diseases; Tooth Diseases; Necrosis; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative; Dental Pulp Necrosis; Inorganic Chemicals; Anions; Ions; Electrolytes; Hydroxides; Alkalies; Calcium Compounds; Calcium Hydroxide
• Other Study ID Numbers: raneemICM10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No