Efficacy of an Antibacterial Toothpaste and Patients' Satisfaction
Primary Purpose
Caries, Gingivitis
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Brushing
Sponsored by
About this trial
This is an interventional prevention trial for Caries
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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;
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Recently introduced toothpaste
Commercial toothpaste
Arm Description
Brushing twice a day with a recently introduced toothpaste.
Brushing twice a day with a commercially available toothpaste.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Plaque index
The plaque will be disclosed using a disclosing solution and recorded as follows: score 0 = absence of plaque; score 1 = separate flecks of plaque on the cervical margin; score 2 = a thin, continuous band of plaque [up to 1 mm] at the cervical margin of the tooth; score 3 = a band of plaque wider than 1 mm, but covering less than one-third of the tooth crown; score 4 = plaque covering at least one-third, but less than two-third of the crown of the tooth; score 5 = plaque covering 2/3-crown or more of the crown of the tooth.
Gingival index
A North Carolina periodontal probe (Hu-Friedy, Chicago, IL, USA) will be used for determine gingival index according to the following scale: score 0 = absence of inflammation; score 1 = mild inflammation-slightly slight change in color and little change in texture; score 2 = moderate inflammation-moderate glazing, redness, edema, and hypertrophy; score 3 = severe inflammation-marked redness and hypertrophy.
Dentin hypersensitivity
Patients with self-reported dentin hypersensitivity will be considered. A 1-s air blast from approximately 1 cm distance will be applied onto exposed dentine. The participant's response will be assessed using the 4-point Schiff Sensitivity Scale (from 0: participant does not respond, to 3: participant responds to stimulus, considers it painful, and requests discontinuation;
Tooth colour
Participants' satisfaction before and after treatment will be recorded and the difference will be assessed. In order to obtain the data concerning patients' satisfaction with tooth color, a questionnaire containing aesthetic numeric visual-analogue scale ranging from 1 to 10 will be given to the subjects.
Full Information
NCT ID
NCT05569850
First Posted
September 27, 2022
Last Updated
October 3, 2022
Sponsor
University of Bologna
Collaborators
Unilever R&D
1. Study Identification
Unique Protocol Identification Number
NCT05569850
Brief Title
Efficacy of an Antibacterial Toothpaste and Patients' Satisfaction
Official Title
In Vivo Evaluation of Antibacterial Toothpaste Efficiency and Patients' Satisfaction: a Double-blind Randomised Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2022 (Anticipated)
Primary Completion Date
December 1, 2022 (Anticipated)
Study Completion Date
December 20, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Bologna
Collaborators
Unilever R&D
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Caries, Gingivitis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Recently introduced toothpaste
Arm Type
Experimental
Arm Description
Brushing twice a day with a recently introduced toothpaste.
Arm Title
Commercial toothpaste
Arm Type
Active Comparator
Arm Description
Brushing twice a day with a commercially available toothpaste.
Intervention Type
Other
Intervention Name(s)
Brushing
Intervention Description
Brushing the teeth 2x a day for 4 weeks.
Primary Outcome Measure Information:
Title
Bacterial count of Streptococcus mutans (S. mutans)
Description
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.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Plaque index
Description
The plaque will be disclosed using a disclosing solution and recorded as follows: score 0 = absence of plaque; score 1 = separate flecks of plaque on the cervical margin; score 2 = a thin, continuous band of plaque [up to 1 mm] at the cervical margin of the tooth; score 3 = a band of plaque wider than 1 mm, but covering less than one-third of the tooth crown; score 4 = plaque covering at least one-third, but less than two-third of the crown of the tooth; score 5 = plaque covering 2/3-crown or more of the crown of the tooth.
Time Frame
4 weeks
Title
Gingival index
Description
A North Carolina periodontal probe (Hu-Friedy, Chicago, IL, USA) will be used for determine gingival index according to the following scale: score 0 = absence of inflammation; score 1 = mild inflammation-slightly slight change in color and little change in texture; score 2 = moderate inflammation-moderate glazing, redness, edema, and hypertrophy; score 3 = severe inflammation-marked redness and hypertrophy.
Time Frame
4 weeks
Title
Dentin hypersensitivity
Description
Patients with self-reported dentin hypersensitivity will be considered. A 1-s air blast from approximately 1 cm distance will be applied onto exposed dentine. The participant's response will be assessed using the 4-point Schiff Sensitivity Scale (from 0: participant does not respond, to 3: participant responds to stimulus, considers it painful, and requests discontinuation;
Time Frame
4 weeks
Title
Tooth colour
Description
Participants' satisfaction before and after treatment will be recorded and the difference will be assessed. In order to obtain the data concerning patients' satisfaction with tooth color, a questionnaire containing aesthetic numeric visual-analogue scale ranging from 1 to 10 will be given to the subjects.
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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;
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Efficacy of an Antibacterial Toothpaste and Patients' Satisfaction
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