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
About this trial
This is an interventional treatment trial for Halitosis
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.
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
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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