Postoperative Pain and Antibacterial Efficacy After Root Canal Irrigation With Curcumin or Sodium Hypochlorite

January 24, 2021 updated by: Eman Medhat, Cairo University

Assessment of Postoperative Pain and Antibacterial Efficacy After Root Canal Irrigation With Curcumin Versus Sodium Hypochlorite in Patients With Necrotic Mandibular Molars: Randomized Clinical Trial

This study aims to compare the effect of 2% curcumin solution versus 2.5% sodium hypochlorite as irrigating solutions in necrotic mandibular molars in terms of postoperative pain and antibacterial effect.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

patients with necrotic mandibular molars will be selected

  1. Diagnostic procedures:

    • Personal information (name, age, gender, address and phone number), full medical and dental histories using schematic charts will be obtained from all patients participating in this research.
    • History of chief complaint will be obtained in the dental history chart.
    • Clinical and radiographic evaluation for each tooth included in this study will be recorded. The tooth will be examined for presence of extensive caries or pulp exposures. Soft tissue examination and tooth mobility evaluation will be done by percussion and palpation.
    • Extraoral examination will be performed by visual inspection of the face and neck and palpation for any swollen lymph nodes.
    • Each tooth will be evaluated for sensitivity using electric pulp tester. Diagnosis will also be confirmed by the absence of bleeding after access cavity preparation.
    • Final Diagnosis: Mature mandibular asymptomatic necrotic molars with normal periapical radiographic appearance.
    • The operator will explicitly explain the trial steps to the patients, and an informed consent will be signed by patients who accept enrollment.
    • Pain scale chart will be given to each patient to rate his /her pain level before endodontic treatment as preoperative reading using a Numerical Rating Scale (NRS).

  2. Endodontic procedures:

    • All the performed steps of root canal treatment will be included in the chart of endodontic procedures.
    • The tooth will be isolated with rubber dam to maintain aseptic field, after isolation the tooth and surrounding field will be disinfected by a protocol using 3% hydrogen peroxide and 2.5% sodium hypochlorite before and after coronal access cavity preparation.
    • The initial sample S1 will be collected from root canals before preparation using sterile paper points. Each root canal will be dried with 3 sterile paper points ISO# 15 which will be left inside the root canal for 1 minute each with pumping movements to generate a suspension with bacteria of the main pulpal area.
    • The paper points will be immediately placed in sterile test tubes containing reduced transport medium of thioglycolate and sent to the Microbiology Laboratory, Faculty of Medicine, Cairo University for microbiologic processing to be cultured within one hour.
    • Root canals will be mechanically prepared in a crown-down approach using ProTaper Universal NiTi files in an X-Smart endodontic motor according to the manufacture instructions.
    • The canals will be thoroughly irrigated between every two subsequent files using 2 ml of 2.5% NaOCl using a side vented needle (gauge 29) to control the possibility of irrigant apical extrusion.
    • After complete root canal preparation all canals will be flushed with 17 % EDTA followed by sterile saline.

  3. Random allocation:

    • According to the randomization sequence, after complete root canal preparation patients will be assigned to one of 2 groups:

      • Intervention Group (G1): each canal will be flushed using 5 ml of curcumin solution in a plastic syringe with a side vented needle (gauge 29) inserted 1 ml shorter than the working length.
      • Comparator Group (G2): each canal will be flushed using 5 ml of 2.5% sodium hypochlorite in a plastic syringe with side vented needle (gauge 29) inserted 1 ml shorter than the working length.
    • After flushing the canals with each irrigating solution all canals will be flushed with 10 ml sterile saline and the final sample S2 will be collected in the same manner as S1 using sterile paper points ISO # 30/0.02 or # 40/0.02, corresponding to the size of the master apical file F3 or F4, respectively.
    • Root canals will be dried using ProTaper paper points. The root canals will be obturated using the modified single cone technique with resin based root canal sealer and ProTaper gutta-percha cones size F3 or F4 according to the size of the final finishing file, together with auxiliary cones ISO # 25/0.02.
    • After obturation, a cotton pellet will be placed in the pulp chamber and the access cavity will be sealed with a temporary filling.
    • All patients will be asked to record their postoperative pain level on Numerical Rating Scale (NRS) at 8, 24 and 48 hours postoperatively.

Study Type

Interventional

Enrollment (Anticipated)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patient's age between 18-50 years.
  2. Male and female.
  3. Systemically healthy patients (ASA I or II).
  4. Mature mandibular molar teeth with: Necrotic pulps, normal periapical radiographic appearance and no intra-canal calcifications or internal resorptive lesions

Exclusion Criteria:

  1. Medically compromised patients having substantive functional limitations (ASA III or IV).
  2. Patients having two or more adjacent teeth requiring endodontic treatment.
  3. Patients who received antibiotic therapy within the last three months before treatment.
  4. Patients administered analgesics in the last 24 hours before treatment.

  5. Teeth with:

    • Vital pulps.
    • Immature apices.
    • Acute periapical abscess, swellings and facial cellulitis.
    • Periodontally hopeless (mobility grade II or III).
    • Previous root canal treatment.
    • Non-restorable coronal portion.
  6. TMJ problems, bruxism or traumatic occlusion.
  7. Inability to perceive the given instructions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: curcumin irrigant
final flush root canal irrigation with 5 ml curcumin solution
Other: curcumin solution
2 % curcumin solution as root canal irrigant
EXPERIMENTAL: sodium hypochlorite
final flush root canal irrigation with 5 ml sodium hypochlorite
Other: sodium hypochlorite
2.5% sodium hypochlorite solution as root canal irrigant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative pain at 8 hours
Time Frame: 8 hours

recorded by 11-point NRS scale with scores from 0 to 10, with 0 for having no symptoms and 10 having worst imaginable symptoms. Pain levels will be categorized as follows:

  • 0 = no pain.
  • 1-3= mild pain.
  • 4-6= moderate pain.
  • 7-10= severe pain. scale with scores from 0 to 10, with 0 for having no symptoms and 10 having worst imaginable symptoms. Pain levels will be categorized as follows:
  • 0 = no pain.
  • 1-3= mild pain.
  • 4-6= moderate pain.
  • 7-10=severe pain
8 hours
postoperative pain at 24 hours
Time Frame: 24 hours
recorded by 11-point NRS scale with scores from 0 to 10, with 0 for having no symptoms and 10 having worst imaginable symptoms. Pain levels will be categorized as follows:
24 hours
postoperative pain at 48 hours
Time Frame: 48 hours
recorded by 11-point NRS scale with scores from 0 to 10, with 0 for having no symptoms and 10 having worst imaginable symptoms. Pain levels will be categorized as follows:
48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
antibacterial effect
Time Frame: during treatment
assessment through culture and the count of Colony-Forming Units(CFUs)
during treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Principal Investigator: eman medhat, Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

January 1, 2021

Primary Completion (ANTICIPATED)

December 1, 2021

Study Completion (ANTICIPATED)

March 1, 2022

Study Registration Dates

First Submitted

January 24, 2021

First Submitted That Met QC Criteria

January 24, 2021

First Posted (ACTUAL)

January 28, 2021

Study Record Updates

Last Update Posted (ACTUAL)

January 28, 2021

Last Update Submitted That Met QC Criteria

January 24, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CU-ENDO-11-10-2020

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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