Effectiveness of Toothbrushing Habits of Preschool Children, With or Without a Toothbrushing Assisting Application

NCT05788692 | Completed

• 1 other identifier: 523
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 6

Brief Summary

The aim of this study is to investigate the effectiveness of the use of a toothbrushing assisting mobile application in dental plaque removal and adherence to the toothbrushing routine, in preschool children (3-5 yrs old) when brushing with either manual or powered toothbrush. Objectives: To identify the effectiveness in dental plaque control in relation to the following parental characteristics:

• Sociodemographic (area of residence, average income, education level)
• Oral Health status
• Oral Health Literacy
• Parenting style
• Parental oral hygiene practices

Conditions

Dental Plaque; Gingivitis

Keywords

plaque; toothbrush; toothbrush assisting application; children

Outcome Measures

Primary Outcomes (8)

• Change from baseline of mean Plaque score in one month

  According to TURESKY QUIGLEY/HEIN plaque index: '0' = No plaque present, '1' = Separate flecks of plaque at the cervical margin, '2' = A thin continuous band of plaque (up to 1 mm) at the cervical margin,'3'= A band of plaque wider than 1 mm but covering less than one-third of the side of the crown of the tooth. '4' = Plaque covering at least one-third but less than two-thirds of the side of crown of the tooth, '5' = Plaque covering two-thirds or more of the side of the crown of the tooth.

  one month

• Change from baseline of Gingival Index score in one month

  Gingivitis according to Gingival Index (GI) by Löe - Silness, on 6 sites of teeth.Scoring criteria for GI are 0=Normal gingival, 1=Mild inflammation slight change in color, slight edema, no bleeding on probing, 2=Moderate inflammation, redness, edema and glazing, bleeding on probing, 3=Severe inflammation, marked redness and edema, ulceration, tendency for spontaneous bleeding.

  one month

• Change from baseline of Calculus Index score in one month

  Will be recorded using Calculus Surface Index (CSI). Presence (=0) or absence (=1) of calculus on the lingual surface of the lower 4 anterior teeth will be assessed by visual examination with mouth mirror and the percentage of the surfaces with calculus to those examined in total will be recorded for each individual

  one month

• Change in times of brushing in one month

  Will be collected via a checklist

  one month

• Change from baseline of mean Plaque score in six months

  According to TURESKY QUIGLEY/HEIN plaque index: '0' = No plaque present, '1' = Separate flecks of plaque at the cervical margin, '2' = A thin continuous band of plaque (up to 1 mm) at the cervical margin,'3'= A band of plaque wider than 1 mm but covering less than one-third of the side of the crown of the tooth. '4' = Plaque covering at least one-third but less than two-thirds of the side of crown of the tooth, '5' = Plaque covering two-thirds or more of the side of the crown of the tooth.

  six months

• Change from baseline of Gingival Index score in six months

  Gingivitis according to Gingival Index (GI) by Löe - Silness, on 6 sites of teeth.Scoring criteria for GI are 0=Normal gingival, 1=Mild inflammation slight change in color, slight edema, no bleeding on probing, 2=Moderate inflammation, redness, edema and glazing, bleeding on probing, 3=Severe inflammation, marked redness and edema, ulceration, tendency for spontaneous bleeding.

  six months

• Change from baseline of Calculus Index score in six months

  Will be recorded using Calculus Surface Index (CSI). Presence (=0) or absence (=1) of calculus on the lingual surface of the lower 4 anterior teeth will be assessed by visual examination with mouth mirror and the percentage of the surfaces with calculus to those examined in total will be recorded for each individual

  six months

• Change in times of brushing in six month

  Will be collected via a checklist

  six months

Secondary Outcomes (1)

• Change from baseline in mean dmft score in 6 months

  six months

Study Arms (4)

electric toothbrush using a toothbrushing assisting application

EXPERIMENTAL

Children will be brushing with an electric toothbrush two times/day using a toothbrushing assisting application

Device: electric tootbrush; Device: toothbrushing assisting application

electric toothbrush without the application

EXPERIMENTAL

Children will be brushing with an electric toothbrush two times/day without the toothbrushing assisting application

Device: electric tootbrush

manual toothbrush using a toothbrushing assisting application

EXPERIMENTAL

Children will be brushing with a manual toothbrush two times /day using a toothbrushing assisting application

Device: manual toothbrush; Device: toothbrushing assisting application

manual toothbrush without using the application during brushing

EXPERIMENTAL

Children will be brushing with a manual toothbrush two times /day without using the toothbrushing assisting application

Device: manual toothbrush

Interventions

electric tootbrush DEVICE

Participants will brush twice per day with an electric toothbrush

electric toothbrush using a toothbrushing assisting application; electric toothbrush without the application

manual toothbrush DEVICE

Participants will brush twice per day with a manual toothbrush

manual toothbrush using a toothbrushing assisting application; manual toothbrush without using the application during brushing

toothbrushing assisting application DEVICE

Participants will brush twice per day with toothbrushing assisting application

electric toothbrush using a toothbrushing assisting application; manual toothbrush using a toothbrushing assisting application

Eligibility Criteria

• Age: 3 Years - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• children 3-5 years of age
• good general health
• born in Greece and understand Greek language
• at least 16 fully erupted primary teeth with facial and lingual surfaces that can be scored (erupting teeth will not be scored).
• living in the same household with the parent consenting for participation in the study

You may not qualify if:

• any medical condition or medications that affect gingival condition (e.g. antiepileptics)
• tooth surfaces that plaque cannot be scored due to extensive carious lesions
• presence of abscess or fistula , pain or need for urgent dental treatment
• difficulties in communication due to language issues
• lack of cooperation
• use of powered toothbrush in the past

Sponsors & Collaborators

• National and Kapodistrian University of Athens: lead

Study Sites (6)

Paidikos Stathmos of 251 Air Force General Hospital

Athens, 11527, Greece

Location

A Paidikos Stathmos NKUA

Athens, 15772, Greece

Location

B Paidikos Stathmos NKUA

Athens, 16121, Greece

Location

3rd Paidikos Stathmos Vrilissia

Vrilissia, 152 38, Greece

Location

4th Paidikos Stathmos Vrilissia

Vrilissia, 152 38, Greece

Location

1st Paidikos Stathmos Vrilissia

Vrilissia, 15235, Greece

Location

MeSH Terms

Conditions

Dental Plaque; Gingivitis; Plaque, Amyloid

Condition Hierarchy (Ancestors)

Dental Deposits; Tooth Diseases; Stomatognathic Diseases; Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Sotiria Gizani

  Associate Professor and Head, Department of Paediatric Dentistry, School of Dentistry, NKUA

  STUDY CHAIR

• William Papaioanou

  Associate Professor, Department of Preventive and Community Dentistry, School of Dentistry, NKUA

  STUDY DIRECTOR

• Andreas Agouropoulos

  Assistant Professor, Department of Paediatric Dentistry, School of Dentistry, NKUA

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: A unique trial identification number (trial ID) will be generated for each participant, details of which will be entered into the trial management system.
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This trial is a 2x2 factorial design, since the four groups of children are formed by the cross-classification of the two factors toothbrush type (powered/manual) and use of the App (yes/no), which both have two levels. Children from sampled schools will be assigned randomly to one of the four experimental groups (A, B, C, D) using pre-prepared lists.

Study Record Dates

• First Submitted: March 12, 2023
• First Posted: March 29, 2023
• Study Start: February 15, 2023
• Primary Completion: June 25, 2023
• Study Completion: September 26, 2023
• Last Updated: November 9, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

GR (6)