NCT05372848

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 3, 2022

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 17, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 6, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 13, 2022

Completed
Last Updated

May 13, 2022

Status Verified

May 1, 2022

Enrollment Period

14 days

First QC Date

May 6, 2022

Last Update Submit

May 12, 2022

Conditions

Keywords

manual toothbrushelectric toothbrushfluorescenceintraoral scannerFluoreCam

Outcome Measures

Primary Outcomes (5)

  • Plaque index

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

    1 week

  • Gingival index

    Gingival index was evaluated through Sillness\&Löe Gingival Index

    1 week

  • 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.

    1 week

  • 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

    1 week

  • intraoral scanner

    plaque was evaluated visually using iTero Flex intraoral scanner

    1 week

Secondary Outcomes (5)

  • Plaque index

    1 month

  • Gingival index

    1 month

  • Fluorescence assesment

    1 month

  • intraoral dental photography

    1 month

  • intraoral scanner

    1 month

Study Arms (2)

Group 1

OTHER

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.

Diagnostic Test: Manual toothbrush

Group 2

OTHER

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.

Diagnostic Test: Electric toothbrush

Interventions

Manual toothbrushDIAGNOSTIC_TEST

volunteers who used manual toothbrush for at least 2 years

Group 1
Electric toothbrushDIAGNOSTIC_TEST

volunteers who used electric toothbrush for at least 2 years

Group 2

Eligibility Criteria

Age20 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • using manual or electric toothbrush for at least 2 years

You may not qualify if:

  • systemic disease,
  • restoration or caries in anterior teeth

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University Faculty of Dentistry

Istanbul, Türkiye, 34854, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    PMID: 14489483BACKGROUND
  • 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.

    PMID: 14121956BACKGROUND
  • 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.

    PMID: 28631885BACKGROUND

MeSH Terms

Conditions

Dental Plaque

Condition Hierarchy (Ancestors)

Dental DepositsTooth DiseasesStomatognathic Diseases

Study Officials

  • Dilek Tağtekin, Prof. Dr.

    Marmara University Faculty of Dentistry Department of Restorative Dentistry

    STUDY DIRECTOR
  • Elif Alkan, Res. Asst.

    Marmara University Faculty of Dentistry Department of Restorative Dentistry

    PRINCIPAL INVESTIGATOR
  • Ataberk Kayhan, Student

    Marmara University Faculty of Dentistry

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SCREENING
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2022

First Posted

May 13, 2022

Study Start

January 3, 2022

Primary Completion

January 17, 2022

Study Completion

March 25, 2022

Last Updated

May 13, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will share

Data obtained from the study will be presented and published internationally

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
Data will be available after the article is published.
Access Criteria
After the article published, corresponding author will share the data when asked.

Locations