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Clinical Evaluation of an Electric and a Manual Toothbrush in Removal of Dental Plaque

Primary Purpose

Plaque, Dental

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Manual toothbrush
Electric toothbrush
Sponsored by
Marmara University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Plaque, Dental focused on measuring manual toothbrush, electric toothbrush, fluorescence, intraoral scanner, FluoreCam

Eligibility Criteria

20 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • using manual or electric toothbrush for at least 2 years

Exclusion Criteria:

  • systemic disease,
  • restoration or caries in anterior teeth

Sites / Locations

  • Marmara University Faculty of Dentistry

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Group 1

Group 2

Arm Description

Group 1 includes volunteers who used to use manual toothbrushes and started to use an electric toothbrush for 1 month with the same daily brushing routine. Fifteen healthy individuals between the ages of 20 and 30 years with no systemic disease, restoration or caries, and whom have the criteria for using a manual toothbrush for at least 2 years included in Group 1.

Group 2 includes volunteers who used to use an electric toothbrush and started to use a manual toothbrush for 1 month with the same daily brushing routines. Fifteen healthy individuals between the ages of 20 and 30 years with no systemic disease, restoration or caries, and whom have the criteria for using an electric toothbrush for at least 2 years included in Group 2.

Outcomes

Primary Outcome Measures

Plaque index
Plaque was evaluated according to Quigley and Hein's Plaque Index criteria
Gingival index
Gingival index was evaluated through Sillness&Löe Gingival Index
Fluorescence assesment
FluoreCam device is based on fluorescence technology. After dental plaque is stained, it is distinguished from healthy enamel tissue in terms of both color and fluorescence properties. FluoreCam system's software determines the amount of dental plaque visually and quantitatively. The stained plaque areas were automatically marked and recorded in the FluoreCam software, simultaneously with the visualization of fluorescence images of upper and lower anterior teeth on the screen. Size and intesity values of stained plaque were obtained from FluoreCam software.
intraoral dental photography
dental plaque was evaluated using a digital camera and mobile dental photography device and scored according to Quigley and Hein's Plaque Index
intraoral scanner
plaque was evaluated visually using iTero Flex intraoral scanner

Secondary Outcome Measures

Plaque index
Plaque was evaluated according to Quigley and Hein's Plaque Index criteria
Gingival index
Gingival index was evaluated through Sillness&Löe Gingival Index
Fluorescence assesment
FluoreCam device is based on fluorescence technology. After dental plaque is stained, it is distinguished from healthy enamel tissue in terms of both color and fluorescence properties. FluoreCam system's software determines the amount of dental plaque visually and quantitatively. The stained plaque areas were automatically marked and recorded in the FluoreCam software, simultaneously with the visualization of fluorescence images of upper and lower anterior teeth on the screen. Size and intesity values of stained plaque were obtained from FluoreCam software.
intraoral dental photography
dental plaque was evaluated using a digital camera and mobile dental photography device and scored according to Quigley and Hein's Plaque Index
intraoral scanner
plaque was evaluated visually using iTero Flex intraoral scanner

Full Information

First Posted
May 6, 2022
Last Updated
May 12, 2022
Sponsor
Marmara University
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1. Study Identification

Unique Protocol Identification Number
NCT05372848
Brief Title
Clinical Evaluation of an Electric and a Manual Toothbrush in Removal of Dental Plaque
Official Title
Clinical Evaluation of an Electric and a Manual Toothbrush in Removal of Dental Plaque by Intraoral Imaging Systems
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
January 3, 2022 (Actual)
Primary Completion Date
January 17, 2022 (Actual)
Study Completion Date
March 25, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Marmara University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The study aimed to evaluate the efficacy of manual and electric toothbrush on dental plaque removal by using various intraoral imaging systems. Thirty healthy individuals using the same type of toothbrush for at least 2 years participated in the study. 12 teeth of each individual, including upper and lower anteriors, were examined. Group 1 including volunteers who used to use manual toothbrushes (MT) started to use an electric toothbrush (ET) and Group 2 including volunteers who used to use an ET and started to use a MT for 1 month with the same daily brushing routines. Following the clinical intraoral examination, plaque (PI) and gingival index (GI) measurements were performed 5 hours after brushing. The GI was evaluated through Sillness&Löe Gingival Index. The PI was evaluated according to Quigley and Hein's Plaque Index criteria and was scored clinically on visual inspection and digital imaging systems including FluoreCam, DSLR Camera, D-Light Pro, Smile Lite MDP, iTero Element Flex. The data was evaluated under p<0.005 significant level.
Detailed Description
Patient and teeth selection criteria Ten healthy individuals between the ages of 20 and 30 years with no systemic disease, restoration or caries, and whom have the criteria for using the same type of toothbrush for 2 years (15 of them use manual toothbrushes and 15 of them use electric toothbrushes) participated in the study. 12 teeth of each individual, including upper and lower anteriors, were examined. The researchers supplied the volunteers with a manual toothbrush (Oral-B toothbrush Pro Expert Complete, Procter&Gamble, USA), an electronic toothbrush with replacement head (Oral-B Cross Action toothbrush replacement head, Procter&Gamble, USA), and a toothpaste (Oral-B Professional Toothpaste and Enamel Pro Repair Toothpaste, Procter&Gamble, USA). Changing the Type of Toothbrush The first group (Group 1) includes volunteers who used to use manual toothbrushes and started to use an electric toothbrush for 1 month with the same daily brushing routine. The second group (Group 2) includes volunteers who used to use an electric toothbrush and started to use a manual toothbrush for 1 month with the same daily brushing routines. Plaque and gingival index measurements Following the clinical intraoral examination of the volunteers in both groups, plaque and gingival index measurements were performed 5 hours after brushing. Regarding the plaque detection, a special 3-tone plaque staining product, Tri Plaque ID gel (GC Corp., Tokyo, Japan), was used to demonstrate the quantity and quality of the plaques on teeth' surfaces. The staining gel was applied onto buccal surfaces of upper and lower anterior teeth. The plaque and gingival indexes were both evaluated initially, 1 week, and 1 month after the toothbrush changes. The plaque index was evaluated according to Quigley and Hein's Plaque Index criteria. The gingival index was evaluated through Sillness & Löe Gingival Index and was scored clinically on visual inspection, digitally on dental photographs and digital imaging systems. Quigley ve Hein Plaque Index 0 -> No plaque 1 -> Flecks of stain of the gingival margin 2 -> Definitive line of plaque on gingival margin 3 -> Gingival third of surface 4 -> Two-thirds of surface 5 -> Greater then 2/3rd of the surface Sillness & Löe Gingival Index 0 -> Healthy gingiva 1 -> Slight change in color and mild inflammation, no bleeding 2 -> Redness, moderate inflammation, bleeding on probing/pressure 3 -> Marked redness, severe inflammation, spontaneous bleeding Monitorization with intraoral dental photography The stained and unstained photographs of the teeth were taken initially, one week, and one month after the toothbrush changes. A camera (Nikon D7100), a macro lens (Nikon, 105mm VR macro lens), and a TTL dual macro flashlight (Meike MK-MT24N) was used for the DSLR photography. The camera parameters were set to ISO 400, diaphragm f/25, and shutter speed 1/125. A mobile dental photography device, Smile Lite MDP, was also used in combination with a smart phone (iPhone 12 Mini, Apple Inc, CA, USA) as an alternative photography technique. CP filter was used for all the photographs taken with Smart Lite MDP. The photographs with and without CP were taken without calibrating the white balance (WB) in auto white balance (AWB) mode. Additionally, a led curing unit D-Light Pro was used in detection mode in combination with the DSLR camera to enhance the visualization of the stained plaque. ISO was set at 1600 and diaphragm f/11 for photography with the D-Light Pro. The quantity of the plaque on tooth surfaces was scored through the photographic analysis. Monitorization with digital imaging systems The stained and unstained measurements were performed initially, one week, and one month after the toothbrush changes by using FluoreCam and iTero Flex devices. After the plaque was stained, it was distinguished from healthy enamel tissue in terms of both color and fluorescence properties. FluoreCam device was used as one of the methods to determine the amount of dental plaque visually and numerically in this study. The stained plaque areas were automatically marked and recorded in the FluoreCam software, simultaneously with the visualization of fluorescence images of upper and lower anterior teeth on the screen. Size and intensity values of stained plaque were obtained from FluoreCam software. Size values represent the area of the plaque, meanwhile intensity values demonstrate the amount of mineral loss and were always represented as a negative number. Decreasing values in intensity (e.g., from -15 to -10) signify that the lesion (mineral content) had slightly improved. The images of the anterior teeth were also taken by using a real-time intraoral scanner, iTero Element Flex (AlignTech, Carlstadt, USA) to digitalize and distinguish the plaque dye to provide clear 3D images and better visual assessment. Plaque measurements and gingival index scores at initial, one week, and one month after the toothbrush change; for Group 1 and Group 2 were evaluated statistically using Mann Whitney U test. Additionally, the images obtained by the FluoreCam device were compared on the system software and evaluated statistically using Mann Whitney U and Wilcoxon tests.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plaque, Dental
Keywords
manual toothbrush, electric toothbrush, fluorescence, intraoral scanner, FluoreCam

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Other
Arm Description
Group 1 includes volunteers who used to use manual toothbrushes and started to use an electric toothbrush for 1 month with the same daily brushing routine. Fifteen healthy individuals between the ages of 20 and 30 years with no systemic disease, restoration or caries, and whom have the criteria for using a manual toothbrush for at least 2 years included in Group 1.
Arm Title
Group 2
Arm Type
Other
Arm Description
Group 2 includes volunteers who used to use an electric toothbrush and started to use a manual toothbrush for 1 month with the same daily brushing routines. Fifteen healthy individuals between the ages of 20 and 30 years with no systemic disease, restoration or caries, and whom have the criteria for using an electric toothbrush for at least 2 years included in Group 2.
Intervention Type
Diagnostic Test
Intervention Name(s)
Manual toothbrush
Intervention Description
volunteers who used manual toothbrush for at least 2 years
Intervention Type
Diagnostic Test
Intervention Name(s)
Electric toothbrush
Intervention Description
volunteers who used electric toothbrush for at least 2 years
Primary Outcome Measure Information:
Title
Plaque index
Description
Plaque was evaluated according to Quigley and Hein's Plaque Index criteria
Time Frame
1 week
Title
Gingival index
Description
Gingival index was evaluated through Sillness&Löe Gingival Index
Time Frame
1 week
Title
Fluorescence assesment
Description
FluoreCam device is based on fluorescence technology. After dental plaque is stained, it is distinguished from healthy enamel tissue in terms of both color and fluorescence properties. FluoreCam system's software determines the amount of dental plaque visually and quantitatively. The stained plaque areas were automatically marked and recorded in the FluoreCam software, simultaneously with the visualization of fluorescence images of upper and lower anterior teeth on the screen. Size and intesity values of stained plaque were obtained from FluoreCam software.
Time Frame
1 week
Title
intraoral dental photography
Description
dental plaque was evaluated using a digital camera and mobile dental photography device and scored according to Quigley and Hein's Plaque Index
Time Frame
1 week
Title
intraoral scanner
Description
plaque was evaluated visually using iTero Flex intraoral scanner
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Plaque index
Description
Plaque was evaluated according to Quigley and Hein's Plaque Index criteria
Time Frame
1 month
Title
Gingival index
Description
Gingival index was evaluated through Sillness&Löe Gingival Index
Time Frame
1 month
Title
Fluorescence assesment
Description
FluoreCam device is based on fluorescence technology. After dental plaque is stained, it is distinguished from healthy enamel tissue in terms of both color and fluorescence properties. FluoreCam system's software determines the amount of dental plaque visually and quantitatively. The stained plaque areas were automatically marked and recorded in the FluoreCam software, simultaneously with the visualization of fluorescence images of upper and lower anterior teeth on the screen. Size and intesity values of stained plaque were obtained from FluoreCam software.
Time Frame
1 month
Title
intraoral dental photography
Description
dental plaque was evaluated using a digital camera and mobile dental photography device and scored according to Quigley and Hein's Plaque Index
Time Frame
1 month
Title
intraoral scanner
Description
plaque was evaluated visually using iTero Flex intraoral scanner
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: using manual or electric toothbrush for at least 2 years Exclusion Criteria: systemic disease, restoration or caries in anterior teeth
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dilek Tağtekin, Prof. Dr.
Organizational Affiliation
Marmara University Faculty of Dentistry Department of Restorative Dentistry
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Elif Alkan, Res. Asst.
Organizational Affiliation
Marmara University Faculty of Dentistry Department of Restorative Dentistry
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ataberk Kayhan, Student
Organizational Affiliation
Marmara University Faculty of Dentistry
Official's Role
Study Chair
Facility Information:
Facility Name
Marmara University Faculty of Dentistry
City
Istanbul
State/Province
Türkiye
ZIP/Postal Code
34854
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data obtained from the study will be presented and published internationally
IPD Sharing Time Frame
Data will be available after the article is published.
IPD Sharing Access Criteria
After the article published, corresponding author will share the data when asked.
Citations:
PubMed Identifier
14489483
Citation
QUIGLEY GA, HEIN JW. Comparative cleansing efficiency of manual and power brushing. J Am Dent Assoc. 1962 Jul;65:26-9. doi: 10.14219/jada.archive.1962.0184. No abstract available.
Results Reference
background
PubMed Identifier
14121956
Citation
LOE H, SILNESS J. PERIODONTAL DISEASE IN PREGNANCY. I. PREVALENCE AND SEVERITY. Acta Odontol Scand. 1963 Dec;21:533-51. doi: 10.3109/00016356309011240. No abstract available.
Results Reference
background
PubMed Identifier
28631885
Citation
Abufarwa M, Noureldin A, Campbell PM, Buschang PH. Reliability and validity of FluoreCam for white-spot lesion detection: An in vitro study. J Investig Clin Dent. 2018 Feb;9(1). doi: 10.1111/jicd.12277. Epub 2017 Jun 20.
Results Reference
background

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Clinical Evaluation of an Electric and a Manual Toothbrush in Removal of Dental Plaque

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