AzTrials
AzTrials

Plaque, DentalNCT05372848

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

A study testing Manual toothbrush and Electric toothbrush in people with Plaque, Dental, run by Marmara University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 20 to 30 yearsHealthy volunteers can take part
Conditions the study is for
Plaque, Dental
What is being tested?
Manual toothbrush and Electric toothbrush
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteTurkey (Türkiye)
Study dates
3 Jan 2022to 25 Mar 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 30 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • using manual or electric toothbrush for at least 2 years

Who cannot join

  • systemic disease,
  • restoration or caries in anterior teeth

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Marmara University Faculty of Dentistry

    Istanbul, Türkiye, 34854

Other trials in Turkey (Türkiye)

About this study

Official title: Clinical Evaluation of an Electric and a Manual Toothbrush in Removal of Dental Plaque by Intraoral Imaging Systems

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.

Read the 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.

Conditions
Plaque, Dental
Being tested
Manual toothbrush, Electric toothbrush
Keywords
manual toothbrush, electric toothbrush, fluorescence, intraoral scanner, FluoreCam
Medical subject headings
Dental Plaque

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Manual toothbrushDiagnostic test

    volunteers who used manual toothbrush for at least 2 years

  • Electric toothbrushDiagnostic test

    volunteers who used electric toothbrush for at least 2 years

Study groups in NCT05372848
Study groupRoleWhat they receive
Group 1OtherGroup 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.
Receives: Diagnostic Test: Manual toothbrush
Group 2OtherGroup 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.
Receives: Diagnostic Test: Electric toothbrush

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Plaque index

    Plaque was evaluated according to Quigley and Hein's Plaque Index criteria

    Measured: 1 week

  2. Gingival index

    Gingival index was evaluated through Sillness\&Löe Gingival Index

    Measured: 1 week

  3. 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.

    Measured: 1 week

  4. 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

    Measured: 1 week

  5. intraoral scanner

    plaque was evaluated visually using iTero Flex intraoral scanner

    Measured: 1 week

Secondary outcomes (5)
  1. Plaque index

    Plaque was evaluated according to Quigley and Hein's Plaque Index criteria

    Measured: 1 month

  2. Gingival index

    Gingival index was evaluated through Sillness\&Löe Gingival Index

    Measured: 1 month

  3. 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.

    Measured: 1 month

  4. 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

    Measured: 1 month

  5. intraoral scanner

    plaque was evaluated visually using iTero Flex intraoral scanner

    Measured: 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 May 2022
  2. Study start3 Jan 2022
  3. Primary completion17 Jan 2022
  4. Study completion25 Mar 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Non-randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Participant
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05372848
Sponsor's protocol ID
mudis34
Status last verified
May 2022
First submitted
6 May 2022
Last updated
13 May 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Data obtained from the study will be presented and published internationally

Publications

  • 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.

    PubMed 14489483
  • 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.

    PubMed 14121956
  • 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.

    PubMed 28631885

Questions about this trial

What is this clinical trial studying?

A study testing Manual toothbrush and Electric toothbrush in people with Plaque, Dental, run by Marmara University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Plaque index (time frame: 1 week). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05372848, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2022.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in