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Evaluation of Clinical and Cost-effectiveness of Different Mouthwashes on Controlling Halitosis Among a Group of Egyptian Children

Primary Purpose

Halitosis

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

About this trial

This is an interventional treatment trial for Halitosis

Eligibility Criteria

8 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Children aged 8-12 years old.
  • Cooperative children.
  • Both genders.
  • Medically free to exclude systemic cause of halitosis.
  • Bad breath

Exclusion Criteria:

  • Children using any other oral hygiene aid other than routine teeth brushing.
  • Children with a known history of allergy to any mouthwash or drug.
  • Parents refuse to participate in the trial.
  • Treatment by antibiotic within one month before the trial(Pham & Nguyen, 2018).
  • Abscess, draining sinus, cellulitis, or other conditions requiring emergency dental treatment.
  • Children using fixed or removable orthodontic appliances or dentures.
  • Children with a history of deleterious oral habits of mouth breathing.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    Placebo Comparator

    Arm Label

    Turmeric mouthwash

    Essential oil mouthwash

    Placebo mouthwash

    Arm Description

    Evaluation of cost-effectiveness of turmeric mouthwash in controlling halitosis

    Evaluation of cost-effectiveness of essential oil mouthwash in controlling halitosis

    Evaluation of cost-effectiveness of placebo mouthwash in controlling halitosis

    Outcomes

    Primary Outcome Measures

    Questionnaire for Patient related side effects
    the measuring unit will be binary (yes/no) from the parent and child. While using the mouthwash: Is the Child's quality of life changed for the better? Acceptance and safety of the mouth wash

    Secondary Outcome Measures

    Cost-effectiveness
    Economic and Clinical effectiveness of turmeric mouthwash Cost effectiveness will be measured according to ICER (Incremental cost-effectiveness ratio)

    Full Information

    First Posted
    May 19, 2021
    Last Updated
    July 25, 2022
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04905940
    Brief Title
    Evaluation of Clinical and Cost-effectiveness of Different Mouthwashes on Controlling Halitosis Among a Group of Egyptian Children
    Official Title
    Evaluation of Cost-Effectiveness And Clinical Effectiveness of Mouthwash Containing Curcuma Longa Versus Essential Oil and A Placebo Mouthwash on Controlling Halitosis Among Egyptian Children: A Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 1, 2022 (Anticipated)
    Primary Completion Date
    December 1, 2022 (Anticipated)
    Study Completion Date
    December 1, 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
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    To evaluate the clinical and cost-effectiveness of mouthwash containing Curcuma longa (Turmeric extract) versus mouthwash containing essential oils and Placebo mouthwash on controlling Halitosis among a group of Egyptian children.
    Detailed Description
    For both interventions: Eligibility screen and patient selection according to the inclusion and exclusion criteria. Readings for halitosis will be recorded using Tanita HC-312F Fitscan Portable Breath Checker (Tanita Corporation, Japan) that shows red, yellow and green colors indicating halitosis degree. Green color=no odour Yellow color=moderate odour Red color=intense odour Children with yellow or red colored results will be included. Participants will be provided with information regarding the risks and benefit of the study and written informed consent will be obtained. Intra and extra-oral examinations and Baseline records photographs, caries assessment by using DMF, gingival condition assessment using Simplified oral hygiene index and personal data collection. Participating children will be offered a full mouth restorative treatment, if needed, before starting the trial to exclude that halitosis comes from food impaction in carious teeth. In another visit, after the full mouth rehabilitation, readings for halitosis will be re-recorded using color coded Tanita HC-312F Fitscan Portable Breath Checker (Tanita corporate, Japan). Patients who will get green colored result will be excluded from the study as the cause of halitosis in those patients would be food impaction in carious teeth. Allocation of the participants who will score more than 2 into either one of three groups; A, B or C. i. A for Experimental group (Turmeric mouthwash) ii. B for first comparator (Essential oil mouthwash) iii. C for second comparator (Placebo) Allocation will be concealed by withdrawing a sealed opaque envelope containing four times folded paper containing the type of mouth wash that will be used. This will decrease performance bias as the operator will not know the group of the participant until taking the score of the patients and finishing the restorative treatment. Blinding of the operator will not be needed as the readings will be objective and recorded using the device (Tanita device) not by the operator (organoleptic method). All mouth rinse samples (experimental and comparators 1&2) will be put into identical white opaque plastic bottles labelled with the codes A, B or C for the blinding of the participant. Group A: The experimental sample is a Turmeric mouthwash which will be prepared by dissolving 10 mg of Turmeric extract in 100 mL of distilled water and 0.005% of flavouring agent peppermint oil (Sharma, 2016). Group B: The first comparator will be the commercial Miswak Listerine mouthwash. Group C: The second comparator will be a placebo mouthwash and will be prepared with peppermint oil and distilled water; essentially the same contents as those in the experimental mouthwash except for the turmeric powder. Every participant will use 2 mouthwash bottles of the same group label that they were allocated to. The first bottle according to their allocation. Patients will be given standard written oral hygiene instructions and mouth washing instructions to rinse twice daily with 10 ml for 1 minute under their parents" supervision for two weeks. The first follow up visit after two weeks, the halitosis score will be recorded by using the Tanita device for numerical record and by asking the parent if there is a bad odour or not. Patients then will be instructed to stop rinsing for the next two weeks while maintaining other oral hygiene instructions. The second follow-up visit after 4 weeks, patients will be given the second bottle and instructed to rinse twice daily with 10 ml for another two weeks. The last follow up visit will be after 6 weeks and the final Halitosis score will be recorded.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    InvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Turmeric mouthwash
    Arm Type
    Experimental
    Arm Description
    Evaluation of cost-effectiveness of turmeric mouthwash in controlling halitosis
    Arm Title
    Essential oil mouthwash
    Arm Type
    Active Comparator
    Arm Description
    Evaluation of cost-effectiveness of essential oil mouthwash in controlling halitosis
    Arm Title
    Placebo mouthwash
    Arm Type
    Placebo Comparator
    Arm Description
    Evaluation of cost-effectiveness of placebo mouthwash in controlling halitosis
    Intervention Type
    Drug
    Intervention Name(s)
    Turmeric mouthwash
    Intervention Description
    Turmeric mouthwash evaluation in controlling halitosis
    Primary Outcome Measure Information:
    Title
    Questionnaire for Patient related side effects
    Description
    the measuring unit will be binary (yes/no) from the parent and child. While using the mouthwash: Is the Child's quality of life changed for the better? Acceptance and safety of the mouth wash
    Time Frame
    45 days
    Secondary Outcome Measure Information:
    Title
    Cost-effectiveness
    Description
    Economic and Clinical effectiveness of turmeric mouthwash Cost effectiveness will be measured according to ICER (Incremental cost-effectiveness ratio)
    Time Frame
    45 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    8 Years
    Maximum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Children aged 8-12 years old. Cooperative children. Both genders. Medically free to exclude systemic cause of halitosis. Bad breath Exclusion Criteria: Children using any other oral hygiene aid other than routine teeth brushing. Children with a known history of allergy to any mouthwash or drug. Parents refuse to participate in the trial. Treatment by antibiotic within one month before the trial(Pham & Nguyen, 2018). Abscess, draining sinus, cellulitis, or other conditions requiring emergency dental treatment. Children using fixed or removable orthodontic appliances or dentures. Children with a history of deleterious oral habits of mouth breathing.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Eman M Elsaeed, B.Sc
    Phone
    +201000994721
    Email
    eman.elsaeed@dentistry.cu.edu.eg
    First Name & Middle Initial & Last Name or Official Title & Degree
    Passant Nagi, PHD
    Phone
    +201280557107
    Email
    Passant.nagi@dentistry.cu.edu.eg

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Evaluation of Clinical and Cost-effectiveness of Different Mouthwashes on Controlling Halitosis Among a Group of Egyptian Children

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