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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Halitosis
• Intervention / Treatment: Drug: Turmeric mouthwash

Detailed Description

For both interventions:

1. Eligibility screen and patient selection according to the inclusion and exclusion criteria.

2. 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.
3. Participants will be provided with information regarding the risks and benefit of the study and written informed consent will be obtained.
4. 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.
5. 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.
6. 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.

7. 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).

8. 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.
9. 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.
10. 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.
11. 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.
12. The last follow up visit will be after 6 weeks and the final Halitosis score will be recorded.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Passant Nagi, PHD; Phone Number: +201280557107; Email: Passant.nagi@dentistry.cu.edu.eg
• Study Contact Backup: Name: Eman M Elsaeed, B.Sc; Phone Number: +201000994721; Email: eman.elsaeed@dentistry.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 8 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Turmeric mouthwash; Evaluation of cost-effectiveness of turmeric mouthwash in controlling halitosis	Drug: Turmeric mouthwash; Turmeric mouthwash evaluation in controlling halitosis
Active Comparator: Essential oil mouthwash; Evaluation of cost-effectiveness of essential oil mouthwash in controlling halitosis	Drug: Turmeric mouthwash; Turmeric mouthwash evaluation in controlling halitosis
Placebo Comparator: Placebo mouthwash; Evaluation of cost-effectiveness of placebo mouthwash in controlling halitosis	Drug: Turmeric mouthwash; Turmeric mouthwash evaluation in controlling halitosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	45 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cost-effectiveness	Economic and Clinical effectiveness of turmeric mouthwash Cost effectiveness will be measured according to ICER (Incremental cost-effectiveness ratio)	45 days

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2022
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: May 19, 2021
• First Submitted That Met QC Criteria: May 24, 2021
• First Posted (Actual): May 28, 2021

Study Record Updates

• Last Update Posted (Actual): July 27, 2022
• Last Update Submitted That Met QC Criteria: July 25, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Halitosis
• Other Study ID Numbers: 14422019461401

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No