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

Status

Active, not recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07327996

Enrollment

Registered

2026-01-08

Start date

2025-09-01

Completion date

2026-07-31

Last updated

2026-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Necrotic Pulp

Keywords

postoperative pain, bacterial load

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.

Interventions

PROCEDURECalcium Hydroxide Intracanal medication

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

PROCEDUREmesoporous silica nanoparticles paste

root canals filled with mesoporous silica nanoparticles for 1 week

PROCEDURECalcium Hydroxide + mesoporous silica nanoparticles

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 40 Years

Healthy volunteers

Yes

Inclusion criteria

* 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.

Design outcomes

Primary

Measure	Time frame	Description
Post-operative pain after application of different intracanal medications	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

Measure	Time frame	Description
bacterial load change after intracanal medication	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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026