AzTrials
AzTrials

Dental CariesNCT04905784

The Impact of Simple Home-based Differential Learning on Oral Hygiene in Children.

A study testing Differential learning and Usual toothbrushing in people with Dental Caries and Gingival Diseases, run by University Medicine Greifswald at 2 sites in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

This randomized clinical trial study aims to investigate the impact of home-based differential learning on tooth brushing, in particular on the reduction of plaque and maintenance of gingival health in children aged 3 to 8 years, compared to the habitual tooth brushing and instruction/demonstration tooth brushing… Read more about this study

Who is it for?
Ages 3 to 8 yearsHealthy volunteers can take part
Conditions the study is for
Dental Caries, Gingival Diseases
What is being tested?
Differential learning and Usual toothbrushing
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
2 sitesGermany
Study dates
31 May 2021to 30 May 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 3 to 8 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Children aged 3 - 8 years.
  • Need for parental assistance with tooth brushing.
  • Need for check-up/ prophylaxis appointment approx. 4 and 12 weeks.

Who cannot join

  • Patients with pain/ patients with signs or symptoms to be treated.
  • Patients with systemic disease that require special attention during their dental treatment.
  • Parents / children who refuse to participate in the study.

Trial locations and contacts

2 sites in 1 country.

Loay Leghrouz, M.Sc. contact

+49 3834-867136

loayleghrouz@hotmail.com

Julian schmoeckel, Dr.,M.Sc. contact

+49 3834-867136

julian.schmoeckel@uni-greifswald.de

Germany2 sites, 2 recruiting
  • Universitätmedizin Greifswald

    Greifswald, Mecklenburg-Vorpommern, 17489

    Christian H Splieth, Prof. Dr., +49 3834-867101, splieth@uni-greifswald.de

    Julian Schmoeckel, Dr., M.Sc., +49 3834-867136, julian.schmoeckel@uni-greifswald.de

    Recruiting
  • University medicine Greifswald

    Greifswald

    Julian Schmoeckel, Dr., 03834 86 7167, julian.schmoeckel@uni-greifswald.de

    Recruiting

Other trials in Germany

About this study

Official title: The Impact of Simple Home-based Differential Learning on Oral Hygiene in Children: A Single-blind Randomized Controlled Clinical Trial

This randomized clinical trial study aims to investigate the impact of home-based differential learning on tooth brushing, in particular on the reduction of plaque and maintenance of gingival health in children aged 3 to 8 years, compared to the habitual tooth brushing and instruction/demonstration tooth brushing learning method.

Read the detailed description

This two-parallel arm single-blind randomized controlled clinical trial will be undertaken at the Department of Preventive and Pediatric Dentistry at the University of Greifswald. The examination of the patient will be undertaken in a dental chair set up using standard infection control guidelines for a dental examination used at the department. The allocation of the patients to the two groups will be done through asking the patients to pick up an envelope randomly from a box which contains the information and explanation for home brushing.

In the first visit, the baseline dental examination and patient acceptance survey will be done to comprehensively assess each participant's oral health status, their oral hygiene status, caries experience and periodontal condition will be recorded.

To assess oral hygiene status we will use plaque index (PI) (Quigley Hein, 1972) on a scale of 0 to 5. Dental caries experience will be recorded by counting the numbers of teeth that are decayed (dt/DT), missing due to caries (mt/MT), and filled (ft/FT) to generate a dmft/DMFT score. Periodontal condition will be recorded using the papillary bleeding index Index (PBI) on a scale of 0 to 4. One trained and calibrated examiner will perform the clinical examinations.

The study and its objectives will be explained to the patients. For the control group, regular instructions and advice will be provided as in any regular prophylaxis session.

For the test group, the exercises and movements to be performed when brushing the teeth will be explained. The patients in both groups will be also provided with explanation leaflet with the exercises and a free toothbrush. There will be no restriction on the type of the fluoridated toothpaste.

The training sheet will include the following exercises:

  • Tooth brushing while lying down.
  • Tooth brushing with one eye covered (i.e. with the hand).
  • Tooth brushing wearing large gloves.
  • Tooth brushing with the non-dominant hand.
  • Tooth brushing using both hands.
  • Different sequence of tooth brushing compared to the practical demonstration (i.e. starting with cleaning the lingual surface instead of occlusal surface).
  • Tooth brushing while both eyes are closed.
  • Tooth brushing with an obstruction on the elbow of the dominant hand (i.e. wraps a piece of cloth/ scarf around the elbow).
  • Tooth brushing while watching 3-5 minutes video (i.e. using YouTube). The parent/ child will be requested to perform each exercise one time a day for 3 days in a row before moving to the next exercise. All parent/ child will be asked to do the exercises in the same sequence. After completing the exercise for each day, children will be asked to put a sticker in the calendar table, which will be provided to them as a motivation to perform the exercises.

There will be 2 follow-ups; the first follow-up after one month will include dental re-examination, using the same methods and criteria as the baseline examination as well as a questionnaire for the parents to assess their experience and acceptance of the used method. The second follow-up will be after 3 months and it will include dental re-examination, using the same methods and criteria as the baseline examination.

Being tested
Differential learning, Usual toothbrushing
Keywords
Caries, Dental, Prevention, Differential, Learning, Toothbrushing
Medical subject headings
Dental Caries, Gingival Diseases

What participants receive

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

  • Differential learningBehavioural

    The patient will be requested to perform different exercises, each exercise one time a day for 3 days in a row before moving to the next exercise. All patient will be asked to do the exercises in the same sequence.

  • Usual toothbrushingBehavioural

    The patients in this group will be provided with the regular oral health instructions, including the traditional toothbrushing recommendations.

Study groups in NCT04905784
Study groupRoleWhat they receive
Control group: Usual brushing.Active comparatorUsual motivation to brush teeth in the clinic (KAI brushing technique) in addition to brushing teeth by the parents.
Receives: Behavioral: Usual toothbrushing
Test group: Differential learning group.ExperimentalUse of differential learning of tooth brushing at home, including children and parents.
Receives: Behavioral: Differential learning

What is being measured

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

  1. Oral hygiene - dental plaque

    Plaque index (QHI: Quigley-Hein plaque index)

    Measured: 1 month

  2. Oral hygiene - dental plaque

    Plaque index (QHI: Quigley-Hein plaque index)

    Measured: 3 months

  3. Oral hygiene - gingivitis

    Gingival bleeding index (PBI: papilla bleeding index)

    Measured: 1 month

  4. Oral hygiene - gingivitis

    Gingival bleeding index (PBI: papilla bleeding index)

    Measured: 3 months

Secondary outcomes (2)
  1. Parental acceptance

    self-designed questionnaire about the acceptance (11 items), assessment using five-point Likert-scale which is from 1 (minimal value) to 5 (maximal value) e.g. with 5 strongly agree and 1 strongly disagree

    Measured: 1 month

  2. Parental acceptance (mid-term)

    self-designed questionnaire about the acceptance (11 items), assessment using five-point Likert-scale which is from 1 (minimal value) to 5 (maximal value) e.g. with 5 strongly agree and 1 strongly disagree

    Measured: 3 months

Timeline

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

  1. First posted28 May 2021
  2. Study start31 May 2021
  3. Primary completion15 Apr 2022 (estimated)
  4. Study completion30 May 2022 (estimated)

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Parallel group, single-blind randomized controlled clinical trial.
Masking
Single blind
Who is masked
Investigator
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04905784
Sponsor's protocol ID
ZZMK KiZHK BB 031/21
Status last verified
Mar 2022
First submitted
3 May 2021
Last updated
17 Mar 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Differential learning and Usual toothbrushing in people with Dental Caries and Gingival Diseases, run by University Medicine Greifswald at 2 sites in Germany.

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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 17 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Germany. 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?

Results are not available in the source record.

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

Contact Loay Leghrouz, M.Sc. (+49 3834-867136, loayleghrouz@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Oral hygiene - dental plaque (time frame: 1 month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 17 Mar 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