NCT07329062

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 30, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2025

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

December 29, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 9, 2026

Completed
Last Updated

January 9, 2026

Status Verified

January 1, 2026

Enrollment Period

5 months

First QC Date

December 29, 2025

Last Update Submit

January 8, 2026

Conditions

Keywords

Oral MalodorPropolisProbiotic toothpaste

Outcome Measures

Primary Outcomes (1)

  • Change in oral malodor severity

    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

Study Arms (4)

Propolis containing toothpaste

EXPERIMENTAL

Participants in this arm used propolis containing toothpaste twice daily for routine oral hygiene during the study period.

Other: Propolis Containing Toothpaste

probiotic containing toothpaste

EXPERIMENTAL

Participants in this arm used probiotic containing toothpaste twice daily for routine oral hygiene during the study period.

Other: Probiotic containing toothpaste

Phosphate-based formulation toothpaste

EXPERIMENTAL

Participants in this arm used phosphate-based formulation toothpaste twice daily for routine oral hygiene during the study period.

Other: Phosphate-based formulation toothpaste

Standard fluoride

EXPERIMENTAL

Participants in this arm used standard fluoride containing toothpaste twice daily for routine oral hygiene during the study period.

Other: Standard fluoride toothpaste

Interventions

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.

Propolis containing toothpaste

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.

probiotic containing toothpaste

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.

Standard fluoride

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.

Phosphate-based formulation toothpaste

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Participants reporting systemic conditions, active periodontal therapy, smoking, or antibiotic usage were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cankiri Karatekin University

Çankırı, Merkez, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Halitosis

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assisstant Professor

Study Record Dates

First Submitted

December 29, 2025

First Posted

January 9, 2026

Study Start

January 30, 2025

Primary Completion

June 30, 2025

Study Completion

December 25, 2025

Last Updated

January 9, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared publicly due to privacy and ethical considerations.

Locations