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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
University of Bologna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Caries

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  1. Tooth anomalies (amelogenesis imperfecta, dentinogenesis imperfecta etc.);
  2. Intrinsic stain (fluorosis);
  3. Caries lesions;
  4. Advanced periodontal disease (probing >2, spontaneous gum bleeding, tooth mobility >1);
  5. Smokers;
  6. Use of orthodontic devices;
  7. Use of antibiotics in the last 3 months;
  8. Use of antibacterial mouth rinses in the last 3 months;
  9. Potential allergies;
  10. 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

    First Posted
    September 27, 2022
    Last Updated
    October 3, 2022
    Sponsor
    University of Bologna
    Collaborators
    Unilever R&D
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    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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