NCT05569850

Brief Summary

The primary objective of this randomized controlled clinical trial (RCCT) will be to compare the efficacy in reducing the quantity of Streptococcus mutans (S. Mutans) in saliva of a recently introduced toothpaste compared to a commercially available toothpaste. The secondary outcomes will be to assess patients' impression of the toothpastes (in terms of taste, satisfaction etc.), and to investigate potential changes in dentin hypersensitivity, plaque formation and gingival inflammation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2022

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

September 27, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 6, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2023

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

April 29, 2025

Completed
Last Updated

April 29, 2025

Status Verified

April 1, 2025

Enrollment Period

8 months

First QC Date

September 27, 2022

Results QC Date

May 9, 2024

Last Update Submit

April 9, 2025

Conditions

CariesGingivitis

Outcome Measures

Primary Outcomes (1)

  • Bacterial Count of Streptococcus Mutans (S. Mutans)

    Agar Mitis salivarius with tellurium and bacitracin (MSTB) will be used for S. mutans isolation. The 0.1 ml saliva sample will be diluted with 0.9 ml of sterile normal saline; next, decimal dilutions of saliva will be made up to 10-3. Each medium plate will be cultured from 0.1 ml of the previously diluted sample to 10-3; then, the sample will be uniformly spread on the agar plates. Finally, the plates will be sealed. They will be incubated for 48 hours at 37°C. The bacterial colonies will be observed under a stereo microscope and identified by morphology and color. The CFU will be multiplied by the number of times the sample was originally diluted and expressed as the number of colony forming units per millilitre (CFU/mL) of saliva.

    4 weeks

Secondary Outcomes (4)

  • Plaque Index

    4 weeks

  • Gingival Index

    4 weeks

  • Dentin Hypersensitivity

    4 weeks

  • Tooth Colour

    4 weeks

Study Arms (2)

Recently introduced toothpaste

EXPERIMENTAL

Brushing twice a day with a recently introduced toothpaste.

Other: Brushing

Commercial toothpaste

ACTIVE COMPARATOR

Brushing twice a day with a commercially available toothpaste.

Other: Brushing

Interventions

BrushingOTHER

Brushing the teeth 2x a day for 4 weeks.

Commercial toothpasteRecently introduced toothpaste

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with minimum 20 teeth;
  • Good oral hygiene level (gingival bleeding index not exceeding 20%)
  • Patients willing to participate in the study and able to sign an informed consent

You may not qualify if:

  • Tooth anomalies (amelogenesis imperfecta, dentinogenesis imperfecta etc.);
  • Intrinsic stain (fluorosis);
  • Caries lesions;
  • Advanced periodontal disease (probing \>2, spontaneous gum bleeding, tooth mobility \>1);
  • Smokers;
  • Use of orthodontic devices;
  • Use of antibiotics in the last 3 months;
  • Use of antibacterial mouth rinses in the last 3 months;
  • Potential allergies;
  • Drug and alcohol abuse;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

DIBINEM

Bologna, BO, 40125, Italy

Location

MeSH Terms

Conditions

Gingivitis

Interventions

Toothbrushing

Condition Hierarchy (Ancestors)

InfectionsGingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Oral HygienePreventive DentistryDentistry

Results Point of Contact

Title
Prof. Lorenzo Breschi
Organization
DIBINE, University of Bologna
lorenzo.breschi@unibo.it
+393482210664

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 27, 2022

First Posted

October 6, 2022

Study Start

December 1, 2022

Primary Completion

July 15, 2023

Study Completion

July 15, 2023

Last Updated

April 29, 2025

Results First Posted

April 29, 2025

Record last verified: 2025-04

Locations

IT(1)