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NCT Number: NCT07327996

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Future University in Egypt

Cairo, New Cairo, 11835, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

  • Inclusion Criteria:
  • 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.
  • Exclusion Criteria:
  • 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.

Treatment and study plan

Calcium Hydroxide Intracanal medication

Procedure

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

mesoporous silica nanoparticles paste

Procedure

root canals filled with mesoporous silica nanoparticles for 1 week

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.

Primary outcomes

  1. Post-operative pain after application of different intracanal medications

    Time frame: from 6 to 72 hours from the treatment

    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

Secondary outcomes

  1. bacterial load change after intracanal medication

    Time frame: immediately in the intervention and after 1 week

    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

Sponsors and collaborators

Lead sponsor

Future University in Egypt

Other

Registry information

Official study title

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"

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 8, 2026
Registry last updated
Jan 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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