NCT04905784

Brief 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 learning method.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2021

Geographic Reach
1 country

2 active sites

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 3, 2021

Completed
25 days until next milestone

First Posted

Study publicly available on registry

May 28, 2021

Completed
3 days until next milestone

Study Start

First participant enrolled

May 31, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2022

Completed
Last Updated

March 17, 2022

Status Verified

March 1, 2022

Enrollment Period

11 months

First QC Date

May 3, 2021

Last Update Submit

March 16, 2022

Conditions

Dental CariesGingival Diseases

Keywords

CariesDentalPreventionDifferentialLearningToothbrushing

Outcome Measures

Primary Outcomes (4)

  • Oral hygiene - dental plaque

    Plaque index (QHI: Quigley-Hein plaque index)

    1 month

  • Oral hygiene - dental plaque

    Plaque index (QHI: Quigley-Hein plaque index)

    3 months

  • Oral hygiene - gingivitis

    Gingival bleeding index (PBI: papilla bleeding index)

    1 month

  • Oral hygiene - gingivitis

    Gingival bleeding index (PBI: papilla bleeding index)

    3 months

Secondary Outcomes (2)

  • Parental acceptance

    1 month

  • Parental acceptance (mid-term)

    3 months

Study Arms (2)

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.

Behavioral: Usual toothbrushing

Test group: Differential learning group.

EXPERIMENTAL

Use of differential learning of tooth brushing at home, including children and parents.

Behavioral: Differential learning

Interventions

Differential learningBEHAVIORAL

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.

Test group: Differential learning group.
Usual toothbrushingBEHAVIORAL

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

Control group: Usual brushing.

Eligibility Criteria

Age3 Years - 8 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Universitätmedizin Greifswald

Greifswald, Mecklenburg-Vorpommern, 17489, Germany

RECRUITING

University medicine Greifswald

Greifswald, Germany

RECRUITING

MeSH Terms

Conditions

Dental CariesGingival Diseases

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic DiseasesPeriodontal DiseasesMouth Diseases

Study Officials

  • Loay Leghrouz, M.Sc.

    Universitätmedizin Greifswald

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Loay Leghrouz, M.Sc.

CONTACT

+49 3834-867136loayleghrouz@hotmail.com

Julian schmoeckel, Dr.,M.Sc.

CONTACT

+49 3834-867136julian.schmoeckel@uni-greifswald.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
The information and instructions for the two groups will be placed in 70 envelopes, each group has 35 envelopes, and then these envelopes will be mixed randomly (as in playing cards) and at the end these envelopes will be placed in a box. Patients will be asked to randomly select an envelope from the box. The investigator assesses oral hygiene in check-up appointments without knowledge of group allocation.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Parallel group, single-blind randomized controlled clinical trial.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2021

First Posted

May 28, 2021

Study Start

May 31, 2021

Primary Completion

April 15, 2022

Study Completion

May 30, 2022

Last Updated

March 17, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

DE(2)