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.
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
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- 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.
Germany2 sites, 2 recruiting
- 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
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.
- Conditions
- Dental Caries, Gingival Diseases
- 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 group | Role | What they receive |
|---|---|---|
| Control group: Usual brushing. | Active comparator | Usual 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. | Experimental | Use 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.
Oral hygiene - dental plaque
Plaque index (QHI: Quigley-Hein plaque index)
Measured: 1 month
Oral hygiene - dental plaque
Plaque index (QHI: Quigley-Hein plaque index)
Measured: 3 months
Oral hygiene - gingivitis
Gingival bleeding index (PBI: papilla bleeding index)
Measured: 1 month
Oral hygiene - gingivitis
Gingival bleeding index (PBI: papilla bleeding index)
Measured: 3 months
Secondary outcomes (2)
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
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.
- First posted28 May 2021
- Study start31 May 2021
- Primary completion15 Apr 2022 (estimated)
- Study completion30 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University Medicine Greifswald
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Loay Leghrouz, M.Sc., Principal investigator, Universitätmedizin Greifswald
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
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Simple Home-based Differential Learning on Oral Hygiene in Children: A Single-blind Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04905784
- Acronym / sponsor ID
- ZZMK KiZHK BB 031/21
- Conditions
- Dental Caries, Gingival Diseases
- Keywords
- Caries, Dental, Prevention, Differential, Learning, Toothbrushing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University Medicine GreifswaldUniversity, hospital or other
- Study start
- 31 May 2021 (actual)
- Primary completion
- 15 Apr 2022 (estimated)
- Study completion
- 30 May 2022 (estimated)
- First posted
- 28 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Parallel group, single-blind randomized controlled clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Control group: Usual brushing. | Active comparator | Behavioral: Usual toothbrushingUsual motivation to brush teeth in the clinic (KAI brushing technique) in addition to brushing teeth by the parents. |
| Test group: Differential learning group. | Experimental | Behavioral: Differential learningUse of differential learning of tooth brushing at home, including children and parents. |
Who may qualify
- Ages
- 3 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children aged 3 - 8 years.
- Need for parental assistance with tooth brushing.
- Need for check-up/ prophylaxis appointment approx. 4 and 12 weeks.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Differential learningThe 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. | Behavioural | Test group: Differential learning group. |
| Usual toothbrushingThe patients in this group will be provided with the regular oral health instructions, including the traditional toothbrushing recommendations. | Behavioural | Control group: Usual brushing. |
Primary outcome
Oral hygiene - dental plaque
Time frame: 1 month
Plaque index (QHI: Quigley-Hein plaque index)
Oral hygiene - dental plaque
Time frame: 3 months
Plaque index (QHI: Quigley-Hein plaque index)
Oral hygiene - gingivitis
Time frame: 1 month
Gingival bleeding index (PBI: papilla bleeding index)
Oral hygiene - gingivitis
Time frame: 3 months
Gingival bleeding index (PBI: papilla bleeding index)
2 secondary outcomes
Parental acceptance
Time frame: 1 month
Parental acceptance (mid-term)
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Loay Leghrouz, M.Sc. principal investigator
Universitätmedizin Greifswald
2 sites in 1 country: see every site and its status.
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.