Clinical trial NCT04845633: Effectiveness of Customized Handle Toothbrush
Official title: Evaluation of the Effectiveness of Customized Handle Toothbrush in Dental Plaque Control in Healthy Children and Children With Down Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Plaque
Dental Prophylaxis
Dental Care
Keywords: Customized Handle Toothbrush
Dental Primary Prevention
Down Syndrome
Lead sponsor: Damascus University
Sponsor class: OTHER
First posted: 2021-04-15
Enrollment: 48
Sex: ALL
Minimum age (years): 6
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: People with special needs suffer from many difficulties, including mental, physical or motor, which increase the difficulty of obtaining good oral health.

Therefore, some adjustments must be made to help these patients maintain oral health.

The aim of the current research is to modify the traditional toothbrush grip by manufacturing a Customized Handle of every young child or people with special needs to improve oral health for those patients by relying on themselves with an effectively way.

Detailed description: Participants will be examined to ensure that the participants have met the sample entry criteria, then the participants will be randomly assigned to four groups each one according to a group:

1. A group of healthy children using conventional toothbrush (12 children).
2. A group of healthy children using toothbrush with Customized Handle (12 children).
3. A group of children with Down syndrome using conventional toothbrush (12 children).
4. A group of children with Down syndrome using toothbrush with Customized Handle (12 children).

Secondly,

1. Researcher will take an impression of the child hand grasp silicon impression material.
2. Researcher will scan the impression with a model scanner and copy it to the computer, then convert it -through a specialized program- to a 3D analog.
3. The program will print the digital analog via the 3D printer using Poly Lactic Acid compound and convert it into a model similar to the patient hand grasp, this model has a place to put the toothbrush.

Third, Brushing instructions:

1. The researcher will teach the participants how to brush by using (tell-show -do) technique.
2. The brushing method that will be used is the modified Stillman technique.
3. Brushing duration must be at least 3 minutes.
4. The brushing must be twice a day.
5. The amount of toothpaste is pea size.

Finally, Mechanism of examination and follow up:

After apply the plaque disclosing solution on the teeth with a bond brush, the plaque will be evaluated with Turesky Modification Quigley-Hein Plaque Index, checking on the buccal and lingual surfaces of all the teeth existing in the participant's mouth.

The participants will be observed in the same day, before and after brushing, and after one week and three weeks

Eligibility criteria: Inclusion criteria:

* Ages between 6-9 years old.
* Participant must have at least 10 teeth free from dental caries on both buccal and lingual surfaces of the teeth.
* TMQHPI is at least 2.
* Cooperative participant (Positive according to Frankel's behavioral rating scale).
* Parents' consent.
* Participant with down syndrome must have been diagnosed by specialist.

Exclusion criteria:

* Children undergoing orthodontic treatment.
* Allergic to any of the toothpaste ingredient used the study.
* Participant used any toothbrush other than the conventional brush before.
* Healthy children Participant with systemic diseases
* Excluding children with Down syndrome who suffer from chronic weakness such as epilepsy or taking medications continuously.

Primary outcomes:
measure: Clinical Plaque Evaluation of Healthy Children and Down Syndrome of Both Groups at the Baseline
timeFrame: Baseline: Pre-brushing
measure: Clinical Plaque Evaluation of Healthy Children and Down Syndrome of Both Groups After Brushing
timeFrame: Post-brushing
Secondary outcomes:
measure: Clinical Plaque Evaluation of Healthy Children and Down Syndrome of Both Groups After a Week
timeFrame: 1 week
Other outcomes:
Locations:
city: Damascus
country: Syrian Arab Republic
facility: Damascus University
Study officials:
affiliation: MSc student in Pedodontics, University of Damascus
name: Line B Droubi, DDs
role: PRINCIPAL_INVESTIGATOR
affiliation: Professor of Pedodontics, Department of Pedodontics, University of Damascus
name: Mohannad G Laflouf, Phd
role: STUDY_DIRECTOR
References:
citation: Reeson MG, Jepson NJ. Customizing the size of toothbrush handles for patients with restricted hand and finger movement. J Prosthet Dent. 2002 Jun;87(6):700. doi: 10.1067/mpr.2002.120840. No abstract available.
citation: Kammers AC, Zanetti AL, Lacerda TE, Aroca JP, Camilotti V, Mendonca MJ. Toothbrush Handles Individually Adapted for Use by Elderly Patients to Reduce Biofilm on Complete Dentures: A Pilot Study. J Clin Diagn Res. 2015 May;9(5):ZC94-7. doi: 10.7860/JCDR/2015/11261.5975. Epub 2015 May 1.