Ignite Creation Date:
2025-12-25 @ 2:52 AM
Ignite Modification Date:
2025-12-26 @ 1:33 AM
Study NCT ID:
NCT04845633
Status:
COMPLETED
Last Update Posted:
2021-08-12
First Post:
2021-04-11
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Effectiveness of Customized Handle Toothbrush
Sponsor:
Damascus University
Organization:
Study Overview
Official Title:
Evaluation of the Effectiveness of Customized Handle Toothbrush in Dental Plaque Control in Healthy Children and Children With Down Syndrome
Status:
COMPLETED
Status Verified Date:
2021-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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
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
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: