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

Primary Purpose

Necrotic Pulp

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
curcumin solution
sodium hypochlorite
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Necrotic Pulp

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    curcumin irrigant

    sodium hypochlorite

    Arm Description

    final flush root canal irrigation with 5 ml curcumin solution

    final flush root canal irrigation with 5 ml sodium hypochlorite

    Outcomes

    Primary Outcome Measures

    postoperative pain at 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
    postoperative pain at 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:
    postoperative pain at 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:

    Secondary Outcome Measures

    antibacterial effect
    assessment through culture and the count of Colony-Forming Units(CFUs)

    Full Information

    First Posted
    January 24, 2021
    Last Updated
    January 24, 2021
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04728386
    Brief Title
    Postoperative Pain and Antibacterial Efficacy After Root Canal Irrigation With Curcumin or Sodium Hypochlorite
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2021 (Anticipated)
    Primary Completion Date
    December 2021 (Anticipated)
    Study Completion Date
    March 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    patients with necrotic mandibular molars will be selected 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). 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. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Necrotic Pulp

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    38 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    curcumin irrigant
    Arm Type
    Experimental
    Arm Description
    final flush root canal irrigation with 5 ml curcumin solution
    Arm Title
    sodium hypochlorite
    Arm Type
    Experimental
    Arm Description
    final flush root canal irrigation with 5 ml sodium hypochlorite
    Intervention Type
    Other
    Intervention Name(s)
    curcumin solution
    Intervention Description
    2 % curcumin solution as root canal irrigant
    Intervention Type
    Other
    Intervention Name(s)
    sodium hypochlorite
    Intervention Description
    2.5% sodium hypochlorite solution as root canal irrigant
    Primary Outcome Measure Information:
    Title
    postoperative pain at 8 hours
    Description
    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
    Time Frame
    8 hours
    Title
    postoperative pain at 24 hours
    Description
    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:
    Time Frame
    24 hours
    Title
    postoperative pain at 48 hours
    Description
    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:
    Time Frame
    48 hours
    Secondary Outcome Measure Information:
    Title
    antibacterial effect
    Description
    assessment through culture and the count of Colony-Forming Units(CFUs)
    Time Frame
    during treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patient's age between 18-50 years. Male and female. Systemically healthy patients (ASA I or II). Mature mandibular molar teeth with: Necrotic pulps, normal periapical radiographic appearance and no intra-canal calcifications or internal resorptive lesions Exclusion Criteria: Medically compromised patients having substantive functional limitations (ASA III or IV). Patients having two or more adjacent teeth requiring endodontic treatment. Patients who received antibiotic therapy within the last three months before treatment. Patients administered analgesics in the last 24 hours before treatment. 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. TMJ problems, bruxism or traumatic occlusion. Inability to perceive the given instructions
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    eman medhat
    Phone
    01276054444
    Email
    emanmedhat10@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    maha nasr
    Phone
    01114367063
    Email
    mahmouhaa87@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    eman medhat
    Organizational Affiliation
    Cairo University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    30815731
    Citation
    Yilmaz K, Tufenkci P, Adiguzel M. The effects of QMix and EndoActivator on postoperative pain in mandibular molars with nonvital pulps: a randomized clinical trial. Clin Oral Investig. 2019 Nov;23(11):4173-4180. doi: 10.1007/s00784-019-02856-6. Epub 2019 Feb 27.
    Results Reference
    background
    PubMed Identifier
    31542283
    Citation
    Sotomil JM, Munchow EA, Pankajakshan D, Spolnik KJ, Ferreira JA, Gregory RL, Bottino MC. Curcumin-A Natural Medicament for Root Canal Disinfection: Effects of Irrigation, Drug Release, and Photoactivation. J Endod. 2019 Nov;45(11):1371-1377. doi: 10.1016/j.joen.2019.08.004. Epub 2019 Sep 18.
    Results Reference
    background
    PubMed Identifier
    28377653
    Citation
    Purohit RN, Bhatt M, Purohit K, Acharya J, Kumar R, Garg R. Clinical and Radiological Evaluation of Turmeric Powder as a Pulpotomy Medicament in Primary Teeth: An in vivo Study. Int J Clin Pediatr Dent. 2017 Jan-Mar;10(1):37-40. doi: 10.5005/jp-journals-10005-1404. Epub 2017 Feb 27.
    Results Reference
    background

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

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