Effectiveness of Customized Handle Toothbrush

Not Applicable

Completed

Conditions: Dental Prophylaxis
Dental Plaque
Dental Care

Interventions: Other: Evaluation of the Effectiveness of Conventional Toothbrush in Dental Plaque Control in Children with Down Syndrome
Other: Evaluation of the Effectiveness of Customized Handle Toothbrush in Dental Plaque Control in Healthy Children
Other: Evaluation of the Effectiveness of Conventional Toothbrush in Dental Plaque Control in Healthy Children
Other: Evaluation of the Effectiveness of Customized Handle Toothbrush in Dental Plaque Control in Children with Down Syndrome

Registration Number: NCT04845633

Lead Sponsor: Damascus University

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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 48

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Children with Down syndrome using conventional toothbrush	Evaluation of the Effectiveness of Conventional Toothbrush in Dental Plaque Control in Children with Down Syndrome	-
Healthy children using toothbrush with Customized Handle	Evaluation of the Effectiveness of Customized Handle Toothbrush in Dental Plaque Control in Healthy Children	-
Healthy children using conventional toothbrush	Evaluation of the Effectiveness of Conventional Toothbrush in Dental Plaque Control in Healthy Children	-
Children with Down syndrome using toothbrush with Customized Handle	Evaluation of the Effectiveness of Customized Handle Toothbrush in Dental Plaque Control in Children with Down Syndrome	-

Primary Outcome Measures

Name	Time	Method
Clinical Plaque Evaluation of Healthy Children and Down Syndrome of Both Groups at the Baseline	Baseline: Pre-brushing	Plaque scores will be assessed with Turesky Modification of the Quigley-Hein Plaque Index (TMQHPI). Plaque will be detected using plaque disclosing agent. In this index the plaque is evaluated and revealed on the buccal and lingual non-restored surfaces of the teeth on a scale of 0 to 5. Where 0 means no plaque presence which is considered as a perfect state, 1 separated ﬂecks of plaque at the cervical margin, 2 a thin continuous back of plaque (up to 1 mm) at the cervical margin, 3 a band of plaque wider than 1 mm but covering less than one-third of the side of the crown of the tooth, 4 plaque covering at least one-third but less than two-thirds of the side of crown of the tooth and finally 5 is considered as the worst state by plaque covering two-thirds or more of the side of the crown of the tooth. All teeth are assessed. The final outcome is determined by an index of the entire mouth by dividing the total score by the number of surfaces examined.
Clinical Plaque Evaluation of Healthy Children and Down Syndrome of Both Groups After Brushing	Post-brushing	Plaque scores will be assessed with Turesky Modification of the Quigley-Hein Plaque Index (TMQHPI). Plaque will be detected using plaque disclosing agent. In this index the plaque is evaluated and revealed on the buccal and lingual non-restored surfaces of the teeth on a scale of 0 to 5. Where 0 means no plaque presence which is considered as a perfect state, 1 separated ﬂecks of plaque at the cervical margin, 2 a thin continuous back of plaque (up to 1 mm) at the cervical margin, 3 a band of plaque wider than 1 mm but covering less than one-third of the side of the crown of the tooth, 4 plaque covering at least one-third but less than two-thirds of the side of crown of the tooth and finally 5 is considered as the worst state by plaque covering two-thirds or more of the side of the crown of the tooth. All teeth are assessed. The final outcome is determined by an index of the entire mouth by dividing the total score by the number of surfaces examined.

Secondary Outcome Measures

Name	Time	Method
Clinical Plaque Evaluation of Healthy Children and Down Syndrome of Both Groups After a Week	1 week	Plaque scores will be assessed with Turesky Modification of the Quigley-Hein Plaque Index (TMQHPI). Plaque will be detected using plaque disclosing agent. In this index the plaque is evaluated and revealed on the buccal and lingual non-restored surfaces of the teeth on a scale of 0 to 5. Where 0 means no plaque presence which is considered as a perfect state, 1 separated ﬂecks of plaque at the cervical margin, 2 a thin continuous back of plaque (up to 1 mm) at the cervical margin, 3 a band of plaque wider than 1 mm but covering less than one-third of the side of the crown of the tooth, 4 plaque covering at least one-third but less than two-thirds of the side of crown of the tooth and finally 5 is considered as the worst state by plaque covering two-thirds or more of the side of the crown of the tooth. All teeth are assessed. The final outcome is determined by an index of the entire mouth by dividing the total score by the number of surfaces examined.