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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

F

Future University in Egypt

Status

Active, not recruiting

Conditions

Necrotic Pulp

Treatments

Procedure: Calcium Hydroxide + mesoporous silica nanoparticles
Procedure: mesoporous silica nanoparticles paste
Procedure: Calcium Hydroxide Intracanal medication

Study type

Interventional

Funder types

Other

Identifiers

NCT07327996
raneemICM10

Details and patient eligibility

About

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.

Enrollment

42 estimated patients

Sex

All

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

42 participants in 3 patient groups

The root canals will be filled with calcium hydroxide paste
Active Comparator group
Description:
using calcium hydroxide paste as intracanal medication for 1week
Treatment:
Procedure: Calcium Hydroxide Intracanal medication
The root canal will be filled with mesoporous silica nanoparticles paste.
Active Comparator group
Description:
using mesoporous silica nanoparticles paste as intracanal medication for week
Treatment:
Procedure: mesoporous silica nanoparticles paste
root canals will be filled with mesoporous silica nanoparticles with calcium hydroxide paste.
Active Comparator group
Description:
using mesoporous silica nanoparticles with calcium hydroxide paste as intracanal medication for 1week
Treatment:
Procedure: Calcium Hydroxide + mesoporous silica nanoparticles

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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