Effectiveness of Customized Handle Toothbrush

Status Completed

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04845633
Study type	Interventional
Source	Damascus University
Contact
Status	Completed
Phase	N/A
Start date	April 9, 2021
Completion date	May 16, 2021

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.