search
Back to results

Rosmarinus Officinalis Versus 2.5%Sodium Hypochlorite as Root Canal Irrigants

Primary Purpose

Necrotic Pulp

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Rosmarinus Officinallis
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Necrotic Pulp

Eligibility Criteria

20 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Systematically healthy patient (ASA I and II).
  2. Age between 20 and 45 years with no sex predilection
  3. Mandibular permanent premolar teeth:

    • Diagnosed clinically with pulp necrosis.
    • Absence of spontaneous pain.
    • Radiographic evidence of root and root canal.
    • Slight widening in the periodontal membrane space or with periapical radiolucency.
    • No response to cold pulp tester (ethyl chloride spray)
  4. Patients who can understand and interpret Numerical rating scale (NRS).
  5. Patients' acceptance to participate in the trial

Exclusion Criteria:

  • 1- Medically compromised patients having significant systemic disorders. (ASA III or IV).

    2- History of intolerance to NSAIDS. 3- If analgesics or antibiotics have been administrated by the patient during the past 24 hours preoperatively as it might alter their pain perception.

    4- Pregnant women: Avoid radiation exposure, anesthesia, and medication. 5- Teeth with: i. Vital teeth. ii. Double canal mandibular premolar teeth iii. Association with swelling or fistulous tract. iv. Acute peri-apical abscess and swelling: Need special treatment steps which could involve additional visits with incision and drainage. Also, it could influence initiation and progression of postoperative pain.

    v. Mobility Grade II or III. vi. Pocket depth more than 5mm. vii. Previous root canal therapy. viii. Non-restorable teeth: Hopeless tooth

  • Immature teeth.
  • Radiographic evidence of external or internal root resorption vertical root fracture, perforation, calcification.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Experimental

    Control Group

    Arm Description

    Rosmarinus officinals will be used as root canal irrigant in treating aysymptomatic mandibular premolars.

    Sodium Hypochlorite used as control in root canal irrigations in treating a asymptomatic mandibular premoalrs.

    Outcomes

    Primary Outcome Measures

    Postoperative pain after root canal treatment.
    The patient is asked to grade his degree of pain on the Numerical Rating Scale (NRS) chart which is an 11 points scale consisting of numbers from 0 to 10, where zero reading represents no pain , 1-3 readings represent mild pain, 4-6 readings represent moderate pain. 7-10 readings represent severe pain .

    Secondary Outcome Measures

    Intracanal bacterial load change.
    The intracanal bacterial load change is calculated through using colony forming units per milliliter test before and after root canal preparation.

    Full Information

    First Posted
    February 9, 2022
    Last Updated
    March 16, 2022
    Sponsor
    Cairo University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05289843
    Brief Title
    Rosmarinus Officinalis Versus 2.5%Sodium Hypochlorite as Root Canal Irrigants
    Official Title
    Effect of Rosmarinus Officinalis Versus 2.5%Sodium Hypochlorite as Root Canal Irrigants on the Intensity of Post-operative Pain and Bacterial Reduction in Asymptomatic Necrotic Mandibular Premolars
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 2022 (Anticipated)
    Primary Completion Date
    July 2023 (Anticipated)
    Study Completion Date
    July 2023 (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
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    To measure the Effect of Rosmarinus Officinalis versus 2.5%Sodium Hypochlorite as Root canal Irrigants on the Intensity of post-operative pain and Bacterial Reduction in asymptomatic necrotic Mandibular premolars.

    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
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Masking Description
    Triple (Participant , Investigator, Outcomes assessor
    Allocation
    Randomized
    Enrollment
    26 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental
    Arm Type
    Experimental
    Arm Description
    Rosmarinus officinals will be used as root canal irrigant in treating aysymptomatic mandibular premolars.
    Arm Title
    Control Group
    Arm Type
    No Intervention
    Arm Description
    Sodium Hypochlorite used as control in root canal irrigations in treating a asymptomatic mandibular premoalrs.
    Intervention Type
    Other
    Intervention Name(s)
    Rosmarinus Officinallis
    Intervention Description
    Root canal Irrigants
    Primary Outcome Measure Information:
    Title
    Postoperative pain after root canal treatment.
    Description
    The patient is asked to grade his degree of pain on the Numerical Rating Scale (NRS) chart which is an 11 points scale consisting of numbers from 0 to 10, where zero reading represents no pain , 1-3 readings represent mild pain, 4-6 readings represent moderate pain. 7-10 readings represent severe pain .
    Time Frame
    Up to 48 hours postoperative.
    Secondary Outcome Measure Information:
    Title
    Intracanal bacterial load change.
    Description
    The intracanal bacterial load change is calculated through using colony forming units per milliliter test before and after root canal preparation.
    Time Frame
    First as a base line and after 15 minutes ( End of the chemo-mechanical preparation).

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Systematically healthy patient (ASA I and II). Age between 20 and 45 years with no sex predilection Mandibular permanent premolar teeth: Diagnosed clinically with pulp necrosis. Absence of spontaneous pain. Radiographic evidence of root and root canal. Slight widening in the periodontal membrane space or with periapical radiolucency. No response to cold pulp tester (ethyl chloride spray) Patients who can understand and interpret Numerical rating scale (NRS). Patients' acceptance to participate in the trial Exclusion Criteria: 1- Medically compromised patients having significant systemic disorders. (ASA III or IV). 2- History of intolerance to NSAIDS. 3- If analgesics or antibiotics have been administrated by the patient during the past 24 hours preoperatively as it might alter their pain perception. 4- Pregnant women: Avoid radiation exposure, anesthesia, and medication. 5- Teeth with: i. Vital teeth. ii. Double canal mandibular premolar teeth iii. Association with swelling or fistulous tract. iv. Acute peri-apical abscess and swelling: Need special treatment steps which could involve additional visits with incision and drainage. Also, it could influence initiation and progression of postoperative pain. v. Mobility Grade II or III. vi. Pocket depth more than 5mm. vii. Previous root canal therapy. viii. Non-restorable teeth: Hopeless tooth Immature teeth. Radiographic evidence of external or internal root resorption vertical root fracture, perforation, calcification.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ayah Ta El Sayed, M.D.S
    Phone
    01221902479
    Ext
    002
    Email
    ayahtarek94@gmail.com

    12. IPD Sharing Statement

    Learn more about this trial

    Rosmarinus Officinalis Versus 2.5%Sodium Hypochlorite as Root Canal Irrigants

    We'll reach out to this number within 24 hrs