Plaque Removal Efficacy of Electric Toothbrushes in ADHD

Dental Plaque Clinical Trial

Official title:

Comparative Evaluation of Plaque Removal Efficacy of Electric Toothbrushes Between Children With Attention Deficit And Hyperactivity Disorder And Healthy Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05935254
• Other study ID #: AdnanMU-ZUCAR.001
• Status: Completed
• Phase: N/A
• Start date: January 29, 2022
• Est. completion date: December 15, 2022

Study information

• Verified date: July 2023
• Source: Aydin Adnan Menderes University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A total of 52 children, 26 of whom were diagnosed with Attention Deficit Hyperactivity Disorder (ADHD) as the experimental group and 26 healthy with no systemic disease as the control group, were included in the study. Then, in order to evaluate the effectiveness of electric and manual toothbrushes, each group was randomly divided into 2 subgroups: Electric and Manual. Children were educated on toothbrushing according to subgroups. DMFT/dft and Löe-Silness Gingival Index (GI) values were recorded. At the first appointment, plaque disclosing was performed and Turesky modification of Quigley-Hein Plaque Index (TQHPI) and Approximal Plaque Index (API) values were recorded to determine the amount of dental plaque before the brushing. Subsequently, children brushed their teeth for 2 minutes with the subgroup's toothbrush type. Then, plaque disclosing and measurements were repeated to determine the amount of plaque removal after brushing. The same procedure steps were repeated at the 1st and 3rd-month appointments, respectively. a p-value below 0.05 was considered statistically significant.

Description:

A total of 52 children, 26 of whom were diagnosed with ADHD, as the experimental group and 26 of whom were healthy, as the control group, were included in the study. Intraoral examination of the children was performed in a dental chair. Standard coding systems and tools developed by the World Health Organization were used to collect data in calculating the criteria for oral health. Soft tissues, tongue, cheek, and palate area were checked in each examination period. Intraoral examination was performed carefully, from the distal right maxillary molars to the most distal right mandibular molars. If there was no cavitation with white spot lesions and black/dark and bright discolorations were considered healthy. According to the DMFT index (Decayed, Missing, and Filled Teeth Index) with the obtained records, DMFT values for permanent teeth and dft values for primary teeth were calculated.

Randomization of the patients to determine the subgroups was carried out by the physician who performed the first examination (B.M.A) using a computer program called www.Random.org (Randomness and Integrity Services Ltd., Ireland). In order to evaluate the effectiveness of electric and manual toothbrushes, each group was divided into 2 subgroups according to the types of brush (electric and manual). There are a total of 4 subgroups in the study. In the manual toothbrush subgroups, the children had a demonstration of how to brush with the Bass Technique on the model. The electric toothbrush subgroups had a demonstration about how to brush their teeth with an electric toothbrush according to the manufacturer's instructions on the model. During the study, children brushed their teeth at home under parental supervision. It is instructed to brush teeth for 2 minutes 2 times a day. During the study period, Sensodyne Promine Kids (GlaxoSmithKline Brazil Ltda, Jacarepagua, Rio de Janeiro, Brazil) were given to children. In both the experimental and control groups and their parents had received instruction to avoid oral hygiene procedures such as flossing and using mouthwash during the study period, except tooth brushing.

After randomization, at the first appointment, Löe-Silness Gingival Index values were recorded in all fully erupted permanent teeth and primary teeth without exfoliation. In order to determine the amount of dental plaque before the first brushing, Mira-2-Ton Plaque Staining Solution (Hager Werken, Germany) was applied to the labial and lingual surfaces of all teeth with a micro brush, and then the children were asked to rinse their mouths with water for 30 seconds. After plaque discoloration, the Approximal Plaque Index and the Turesky Modification of Quigley-Hein Plaque Index values were recorded. The children brushed their teeth in front of a mirror for 2 minutes with the toothbrushes according to subgroups, under the supervision of a physician who was not included in the study. To determine the amount of plaque removal after the first brushing, plaque discoloration was performed again. The Turesky modification of the Quigley-Hein Plaque Index and the Approximal Plaque Index measurements were recorded. The same procedures were repeated to evaluate the brushing habits at the 1st-month and 3rd-month, respectively.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: December 15, 2022
• Est. primary completion date: September 20, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 10 Years

Eligibility

Inclusion Criteria:

• Having not had oral prophylaxis in the last 1 month

• Taking not antibiotics within the last 1 month

• Having not had severe periodontal disease and dental caries

• Having no pain symptoms due to caries in any of their teeth,

• Not using any orthodontic appliances

• Not using an electric toothbrush before

• Having at least 16 teeth in the mouth

Exclusion Criteria:

• Have a complex medical history

• Have psychiatric illness other than attention deficit and hyperactivity disorder

Related Conditions & MeSH terms

• Attention Deficit and Hyperactivity Disorder
• Attention Deficit Disorder with Hyperactivity
• Dental Plaque
• Hyperkinesis

Intervention

Device:
• Plaque removal efficacy of children's electric toothbrush (Oral-B D100 Vitality; Procter & Gamble, Cincinnati, OH, United States)
At the baseline appointment, Löe-Silness Gingival Index values were recorded in all fully erupted permanent teeth and primary teeth without exfoliation. Mira-2-Ton Plaque Staining Solution was applied to the labial and lingual surfaces of all teeth with a micro brush to determine the amount of dental plaque before the first brushing. After plaque discoloration, the Approximal Plaque Index and the Turesky Modification of Quigley-Hein Plaque Index values were recorded. The children brushed their teeth with an electric toothbrush for 2 minutes, under the supervision of a physician who was not included in the study. Plaque discoloration was performed again to determine the amount of plaque removal after the first brushing. Approximal Plaque Index and The Turesky modification of the Quigley-Hein Plaque Index the measurements were recorded. The same procedures were repeated to evaluate the brushing habits at the 1st-month and 3rd-month, respectively.
• Plaque removal efficacy of children's soft manual toothbrush (Oral-B Stages 6-12 years; Procter & Gamble, Cincinnati, OH, United States)
At the baseline appointment, Löe-Silness Gingival Index values were recorded in all fully erupted permanent teeth and primary teeth without exfoliation. Mira-2-Ton Plaque Staining Solution was applied to the labial and lingual surfaces of all teeth with a micro brush to determine the amount of dental plaque before the first brushing. After plaque discoloration, the Approximal Plaque Index and the Turesky Modification of Quigley-Hein Plaque Index values were recorded. The children brushed their teeth with a manual toothbrush for 2 minutes, under the supervision of a physician who was not included in the study. Plaque discoloration was performed again to determine the amount of plaque removal after the first brushing. Approximal Plaque Index and The Turesky modification of the Quigley-Hein Plaque Index the measurements were recorded. The same procedures were repeated to evaluate the brushing habits at the 1st-month and 3rd-month, respectively.

Locations

Country	Name	City	State
Turkey	Aydin Adnan Menderes University Faculty of Dentistry Department of Pediatric Dentistry	Aydin

Sponsors (1)

Lead Sponsor	Collaborator
Aydin Adnan Menderes University

Country where clinical trial is conducted

Turkey, 

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* Note: There are 48 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determination of Gingival Index (GI) values	Evaluation of children's gingival health during the study period	The measurements will be done before the intervention at baseline
Primary	Determination of Gingival Index (GI) values	Evaluation of children's gingival health during the study period	The measurements will be done before the intervention at 1st month
Primary	Determination of Gingival Index (GI) values	Evaluation of children's gingival health during the study period	The measurements will be done before the intervention at 3rd month
Primary	Determination of Turesky modification of Quigley-Hein Plaque Index (TQHPI) values	Evaluation of plaque removal efficiency from labial and lingual surfaces of teeth with a toothbrush	The measurements will be done immediately before the intervention at baseline
Primary	Determination of Turesky modification of Quigley-Hein Plaque Index (TQHPI) values	Evaluation of plaque removal efficiency from labial and lingual surfaces of teeth with a toothbrush	The measurements will be done immediately after the intervention at baseline
Primary	Determination of Turesky modification of Quigley-Hein Plaque Index (TQHPI) values	Evaluation of plaque removal efficiency from labial and lingual surfaces of teeth with a toothbrush	The measurements will be done immediately before the intervention at 1st month
Primary	Determination of Turesky modification of Quigley-Hein Plaque Index (TQHPI) values	Evaluation of plaque removal efficiency from labial and lingual surfaces of teeth with a toothbrush	The measurements will be done immediately after the intervention at 1st month
Primary	Determination of Turesky modification of Quigley-Hein Plaque Index (TQHPI) values	Evaluation of plaque removal efficiency from labial and lingual surfaces of teeth with a toothbrush	The measurements will be done immediately before the intervention at 3rd month
Primary	Determination of Turesky modification of Quigley-Hein Plaque Index (TQHPI) values	Evaluation of plaque removal efficiency from labial and lingual surfaces of teeth with a toothbrush	The measurements will be done immediately after the intervention at 3rd month
Primary	Determination of Approximal Plaque Index (API) values	Evaluation of plaque removal efficiency from proximal surfaces of teeth with a toothbrush	The measurements will be done immediately before the intervention at baseline
Primary	Determination of Approximal Plaque Index (API) values	Evaluation of plaque removal efficiency from proximal surfaces of teeth with a toothbrush	The measurements will be done immediately after the intervention at baseline
Primary	Determination of Approximal Plaque Index (API) values	Evaluation of plaque removal efficiency from proximal surfaces of teeth with a toothbrush	The measurements will be done immediately before the intervention at 1st month
Primary	Determination of Approximal Plaque Index (API) values	Evaluation of plaque removal efficiency from proximal surfaces of teeth with a toothbrush	The measurements will be done immediately after the intervention at 1st month
Primary	Determination of Approximal Plaque Index (API) values	Evaluation of plaque removal efficiency from proximal surfaces of teeth with a toothbrush	The measurements will be done immediately before the intervention at 3rd month
Primary	Determination of Approximal Plaque Index (API) values	Evaluation of plaque removal efficiency from proximal surfaces of teeth with a toothbrush	The measurements will be done immediately after the intervention at 3rd month
Secondary	Determination of the DMFT Index (Decayed, Missing and filled Teeth Index) of the subgroups	To determine the risk of dental caries in the permanent dentition period of children during the study period.	Baseline
Secondary	Determination of the DMFT Index (Decayed, Missing and filled Teeth Index) of the subgroups	To determine the risk of dental caries in the permanent dentition period of children during the study period.	3rd Month
Secondary	Determination of the dft Index (decay filled teeth index) of the subgroups	To determine the risk of dental caries in the primary dentition of children during the study period.	Baseline
Secondary	Determination of the dft Index (decay filled teeth index) of the subgroups	To determine the risk of dental caries in the primary dentition of children during the study period.	3rd Month
Secondary	A questionnaire consisting of 19 questions that all children participating in the study could answer with their parents.	To determine of nutrition, diet, and tooth brushing habits of children and sociodemographic factors	Baseline