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

See also
Status	Clinical Trial	Phase
Completed	`NCT04881357` - Antiplaque/Antigingivitis Effect of Lacer Oros Integral	N/A
Completed	`NCT04561960` - Efficacy of Miswak in Oral Hygiene Maintenance	Phase 4
Completed	`NCT04025684` - Efficacy of Manual Toothbrushes in Removing Dental Plaque	N/A
Completed	`NCT03394729` - Effect of a Propolis Tablet on the Saliva and the Amount of Adolescent Dental Plaque Microbes	Phase 2/Phase 3
Completed	`NCT05187507` - Effectiveness of Theobromine Toothpaste	N/A
Completed	`NCT04485520` - Efficacy of the Extract of Carica Papaya as an Inhibitor of Streptococcus Mutans	N/A
Completed	`NCT02552589` - Effect of Toothpaste on the Reduction of Plaque and Inflammation	N/A
Completed	`NCT02884817` - Essential Oil+ELA, Plaque and Gingivitis	Phase 4
Completed	`NCT02194023` - Clinical Effects of Two New Chlorhexidine Digluconate Formulations: 0.12% and 0.03%.	Phase 2
Completed	`NCT01237782` - Efficacy of a Propolis-based Denture Cleanser	N/A
Completed	`NCT00758394` - Clinical Study to Compare Dental Plaque Control	Phase 3
Completed	`NCT00254345` - Effect of Provisional-Crown Surface Coating on Biofilm Formation	Phase 1
Completed	`NCT05579938` - Effect of Enzymes on Dental Biofilm Accumulation	N/A
Completed	`NCT05038293` - Efficacy of Plaque Removal of a Novel Brushing Device	N/A
Terminated	`NCT05082103` - Effect of Enzymes on Dental Biofilm Accumulation in Healthy Individuals	N/A
Not yet recruiting	`NCT06081868` - RCT on Effectiveness of Oral Health Preventive Programmes in School Children in Uganda	N/A
Completed	`NCT05853679` - Regular Antibacterial Photodynamic Therapy on Oral Hygiene in Elderly Residents	N/A
Completed	`NCT05521230` - Short-Term Anti-plaque Effect of Cymenol Mouthwash Analysed Using Dentius Deep Plaque Software	Phase 1
Completed	`NCT03311438` - Oral Health Intervention Program for Children With Congenital Heart Defects	N/A
Enrolling by invitation	`NCT06122636` - Efficacy of a Probiotic and Microbiological Analysis on Oral Complications Induced by Antineoplastic Therapies in Patients With HNC	N/A

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.