- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07329062
Effect of Toothpastes on Oral Malodor
Investigation of the Effect of Toothpastes With Different Ingredients on Oral Malodor in Young Adults
This study aimed to evaluate the effects of different toothpaste formulations on oral malodor in young adults, addressing the lack of clinical evidence regarding propolis- and probiotic-containing toothpastes, which have predominantly been investigated in mouthrinse, tablet, or chewing gum formulations.
Volunteers aged 18-30 years with baseline organoleptic assessment (OA) and Breath Checker® (BC) scores >0 were randomized into four toothpaste groups: propolis-containing (Glimo Beta), probiotic-containing (Glimo Pi), phosphate-based (Glimo Gamma), and a standard fluoride toothpaste (Sensodyne). Allocation concealment was ensured using identical coded containers, and outcome assessors were blinded. After exclusions, 52 participants completed the study. Oral malodor was evaluated at baseline (T0) and Day 14 (T1) using OA, BC measurements, and self-perceived oral malodor scores.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Merkez
-
Çankırı, Merkez, Turkey (Türkiye)
- Cankiri Karatekin University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
• No systemic diseases or medications known to cause halitosis
- No active periodontal disease requiring treatment
- No antibiotic use within the previous month
- No orthodontic or removable space-maintaining appliances
- Non-smokers
- Organoleptic score >0 and Breath-Checker® (BC) score >0 at baseline
Exclusion Criteria:
- Participants reporting systemic conditions, active periodontal therapy, smoking, or antibiotic usage were excluded.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Propolis containing toothpaste
Participants in this arm used propolis containing toothpaste twice daily for routine oral hygiene during the study period.
|
Participants were instructed to brush their teeth using propolis toothpaste twice daily (morning and evening) for 14 days as part of their routine oral hygiene.
|
|
Experimental: probiotic containing toothpaste
Participants in this arm used probiotic containing toothpaste twice daily for routine oral hygiene during the study period.
|
Participants were instructed to brush their teeth using probiotic toothpaste twice daily (morning and evening) for 14 days as part of their routine oral hygiene.
|
|
Experimental: Phosphate-based formulation toothpaste
Participants in this arm used phosphate-based formulation toothpaste twice daily for routine oral hygiene during the study period.
|
Participants were instructed to brush their teeth using Phosphate-based formulation toothpaste twice daily (morning and evening) for 14 days as part of their routine oral hygiene.
|
|
Experimental: Standard fluoride
Participants in this arm used standard fluoride containing toothpaste twice daily for routine oral hygiene during the study period.
|
Participants were instructed to brush their teeth using standard fluoride toothpaste twice daily (morning and evening) for 14 days as part of their routine oral hygiene.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in oral malodor severity
Time Frame: Baseline and Day 14
|
Oral malodor was assessed using an organoleptic scoring method and a portable breath checker device.
The change in scores from baseline to the end of the intervention period was evaluated.
|
Baseline and Day 14
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Approval No: 18, Date: 29/01/2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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