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
1 other identifier
interventional
30
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2022
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 19, 2021
CompletedFirst Posted
Study publicly available on registry
May 28, 2021
CompletedStudy Start
First participant enrolled
August 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedJuly 27, 2022
July 1, 2022
4 months
May 19, 2021
July 25, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Questionnaire for Patient related side effects
the measuring unit will be binary (yes/no) from the parent and child. While using the mouthwash: 1. Is the Child's quality of life changed for the better? 2. Acceptance and safety of the mouth wash
45 days
Secondary Outcomes (1)
Cost-effectiveness
45 days
Study Arms (3)
Turmeric mouthwash
EXPERIMENTALEvaluation of cost-effectiveness of turmeric mouthwash in controlling halitosis
Essential oil mouthwash
ACTIVE COMPARATOREvaluation of cost-effectiveness of essential oil mouthwash in controlling halitosis
Placebo mouthwash
PLACEBO COMPARATOREvaluation of cost-effectiveness of placebo mouthwash in controlling halitosis
Interventions
Turmeric mouthwash evaluation in controlling halitosis
Eligibility Criteria
You may qualify if:
- Children aged 8-12 years old.
- Cooperative children.
- Both genders.
- Medically free to exclude systemic cause of halitosis.
- Bad breath
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principle investigator
Study Record Dates
First Submitted
May 19, 2021
First Posted
May 28, 2021
Study Start
August 1, 2022
Primary Completion
December 1, 2022
Study Completion
December 1, 2022
Last Updated
July 27, 2022
Record last verified: 2022-07
Data Sharing
- IPD Sharing
- Will not share