Evaluation of Two Different Toothpastes for Clinical Management of Extrinsic Stains.
Primary Purpose
Extrinsic Staining of Tooth - Medication
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Blanx Black Toothpaste
Colgate Sensation White
Sponsored by
About this trial
This is an interventional treatment trial for Extrinsic Staining of Tooth - Medication focused on measuring toothpaste, extrinsic stains
Eligibility Criteria
Inclusion Criteria:
- Age > 18 years
- Presence of extrinsic stains
- Patients with high compliance
Exclusion Criteria:
- Underage patients
- Patients suffering from neurological or psychiatric disorders
- Pregnant women
- Patients undergoing anticancer chemotherapy
- Patients with low compliance
Sites / Locations
- Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Trial Group
Control Group
Arm Description
Use of Blanx Black Toothpaste
Use of Colgate Sensation White toothpaste.
Outcomes
Primary Outcome Measures
Change in BOP - Bleeding on Probing (percentage)
Site-specific assessment of the presence or absence of gum bleeding after the insertion of the periodontal probe for the detection of PPD, detected on 6 sites.
Percentage of sites with bleeding on probing determines the BOP%.
Change in MLI - Modified Lobene Index
The facial surface of each anterior tooth was divided into two regions. The first is the gingival region which was a crescent-shaped band of the labial surface about 2 mm wide adjacent to the free margin of the gingiva and extending to the crest of the interdental papillae of the adjacent teeth. The second is the body region which constitutes the remainder of the labial surface of the tooth.
The gingival and body regions were scored separately.
Intensity - Scoring criteria:
0: no stain;
1: mild stain, from yellow to light brown or gray;
2: mild stain, brown colored;
3: heavy stain, from dark brown to black.
Area - Scoring criteria:
0: no stain;
1: 1/3 extension of the stain;
2: from 1/3 to 2/3 extension of the stain;
3: stain covering over two-thirds of the region. stain extent.
Change in Plaque Control Record (PCR%)
% assessment of the amount of plaque on dental surfaces; it is detected on 4 surfaces: distal, mesial, vestibular, lingual / palatal. The number of sites with plaque is divided by the total number of sites available in the mouth and multiplied by 100. Results indicate the index as a percentage.Scoring criteria:
0: no bleeding
1: mild bleeding
2: severe bleeding The number of bleeding sites is divided per the total number of probed sites; the ratio is multiplied X 100.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04904978
Brief Title
Evaluation of Two Different Toothpastes for Clinical Management of Extrinsic Stains.
Official Title
Evaluation of Two Different Toothpastes for the Clinical Management of Extrinsic Stains: Randomized Clinical Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
May 28, 2021 (Actual)
Primary Completion Date
April 6, 2022 (Actual)
Study Completion Date
April 12, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pavia
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 aim of the study is to assess the efficacy of Blanx Black Toothpaste against extrinsic stains of teeth.
Patients who sign the informed consent will participate to the study.
At the baseline, the collection of Plaque Index, modified Lobene index and Bleeding Index will be performed, giving the instruction for a proper home oral hygiene. Professional supragingival and subgingival dental hygiene with piezoelectric will be performed. Then, patients will be randomly divided into two groups:
Trial Group will use Blanx Black Toothpaste (2 minutes brushing) twice a day for the all the study duration;
Control Group will use Colgate Sensation White Toothpaste (2 minutes brushing) twice a day.
Patients will be reevaluated after 10 days, after 1 month and after 3 months, collecting again the indices and improving home oral care.
Detailed Description
The aim of the study is to assess the efficacy of Blanx Black Toothpaste against extrinsic stains of teeth.
For this purpose, patients addressing to the Dental Hygiene Unit that agree to participate to the study will be enrolled after signing the informed consent.
At the baseline, the collection of Plaque Index, modified Lobene index and Bleeding Index will be performed, giving the instruction for a proper home oral hygiene. Professional supragingival and subgingival dental hygiene with piezoelectric will be performed. Then, patients will be randomly divided into two groups:
Trial Group will use Blanx Black Toothpaste (2 minutes brushing) twice a day for the all the study duration;
Control Group will use Colgate Sensation White Toothpaste (2 minutes brushing) twice a day.
Patients will be reevaluated after 10 days, after 1 month and after 3 months. After the reinforcement of home oral hygiene, the above mentioned indices will be collected.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Extrinsic Staining of Tooth - Medication
Keywords
toothpaste, extrinsic stains
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Trial Group
Arm Type
Experimental
Arm Description
Use of Blanx Black Toothpaste
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Use of Colgate Sensation White toothpaste.
Intervention Type
Other
Intervention Name(s)
Blanx Black Toothpaste
Intervention Description
Use of Blanx Black Toothpaste twice a day per at least 2 minutes.
Intervention Type
Other
Intervention Name(s)
Colgate Sensation White
Intervention Description
Use of Colgate Sensation White Toothpaste twice a day per at least 2 minutes
Primary Outcome Measure Information:
Title
Change in BOP - Bleeding on Probing (percentage)
Description
Site-specific assessment of the presence or absence of gum bleeding after the insertion of the periodontal probe for the detection of PPD, detected on 6 sites.
Percentage of sites with bleeding on probing determines the BOP%.
Time Frame
Baseline, 10 days, 1 month, 3 months
Title
Change in MLI - Modified Lobene Index
Description
The facial surface of each anterior tooth was divided into two regions. The first is the gingival region which was a crescent-shaped band of the labial surface about 2 mm wide adjacent to the free margin of the gingiva and extending to the crest of the interdental papillae of the adjacent teeth. The second is the body region which constitutes the remainder of the labial surface of the tooth.
The gingival and body regions were scored separately.
Intensity - Scoring criteria:
0: no stain;
1: mild stain, from yellow to light brown or gray;
2: mild stain, brown colored;
3: heavy stain, from dark brown to black.
Area - Scoring criteria:
0: no stain;
1: 1/3 extension of the stain;
2: from 1/3 to 2/3 extension of the stain;
3: stain covering over two-thirds of the region. stain extent.
Time Frame
Baseline, 10 days, 1 month, 3 months
Title
Change in Plaque Control Record (PCR%)
Description
% assessment of the amount of plaque on dental surfaces; it is detected on 4 surfaces: distal, mesial, vestibular, lingual / palatal. The number of sites with plaque is divided by the total number of sites available in the mouth and multiplied by 100. Results indicate the index as a percentage.Scoring criteria:
0: no bleeding
1: mild bleeding
2: severe bleeding The number of bleeding sites is divided per the total number of probed sites; the ratio is multiplied X 100.
Time Frame
Baseline, 10 days, 1 month, 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age > 18 years
Presence of extrinsic stains
Patients with high compliance
Exclusion Criteria:
Underage patients
Patients suffering from neurological or psychiatric disorders
Pregnant women
Patients undergoing anticancer chemotherapy
Patients with low compliance
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Scribante, DDS, PhD
Organizational Affiliation
University of Pavia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia
City
Pavia
State/Province
Lombardy
ZIP/Postal Code
27100
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Data will be available upon motivated request to Principal Investigator.
Learn more about this trial
Evaluation of Two Different Toothpastes for Clinical Management of Extrinsic Stains.
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