Clinical trial NCT05935254: Plaque Removal Efficacy of Electric Toothbrushes in ADHD
Official title: Comparative Evaluation of Plaque Removal Efficacy of Electric Toothbrushes Between Children With Attention Deficit And Hyperactivity Disorder And Healthy Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attention Deficit and Hyperactivity Disorder
Dental Plaque
Lead sponsor: Aydin Adnan Menderes University
Sponsor class: OTHER
First posted: 2023-07-07
Enrollment: 52
Sex: ALL
Minimum age (years): 8
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Determination of Gingival Index (GI) values
timeFrame: The measurements will be done before the intervention at baseline
measure: Determination of Gingival Index (GI) values
timeFrame: The measurements will be done before the intervention at 1st month
measure: Determination of Gingival Index (GI) values
timeFrame: The measurements will be done before the intervention at 3rd month
measure: Determination of Turesky modification of Quigley-Hein Plaque Index (TQHPI) values
timeFrame: The measurements will be done immediately before the intervention at baseline
measure: Determination of Turesky modification of Quigley-Hein Plaque Index (TQHPI) values
timeFrame: The measurements will be done immediately after the intervention at baseline
measure: Determination of Turesky modification of Quigley-Hein Plaque Index (TQHPI) values
timeFrame: The measurements will be done immediately before the intervention at 1st month
measure: Determination of Turesky modification of Quigley-Hein Plaque Index (TQHPI) values
timeFrame: The measurements will be done immediately after the intervention at 1st month
measure: Determination of Turesky modification of Quigley-Hein Plaque Index (TQHPI) values
timeFrame: The measurements will be done immediately before the intervention at 3rd month
measure: Determination of Turesky modification of Quigley-Hein Plaque Index (TQHPI) values
timeFrame: The measurements will be done immediately after the intervention at 3rd month
measure: Determination of Approximal Plaque Index (API) values
timeFrame: The measurements will be done immediately before the intervention at baseline
measure: Determination of Approximal Plaque Index (API) values
timeFrame: The measurements will be done immediately after the intervention at baseline
measure: Determination of Approximal Plaque Index (API) values
timeFrame: The measurements will be done immediately before the intervention at 1st month
measure: Determination of Approximal Plaque Index (API) values
timeFrame: The measurements will be done immediately after the intervention at 1st month
measure: Determination of Approximal Plaque Index (API) values
timeFrame: The measurements will be done immediately before the intervention at 3rd month
measure: Determination of Approximal Plaque Index (API) values
timeFrame: The measurements will be done immediately after the intervention at 3rd month
Secondary outcomes:
measure: Determination of the DMFT Index (Decayed, Missing and filled Teeth Index) of the subgroups
timeFrame: Baseline
measure: Determination of the DMFT Index (Decayed, Missing and filled Teeth Index) of the subgroups
timeFrame: 3rd Month
measure: Determination of the dft Index (decay filled teeth index) of the subgroups
timeFrame: Baseline
measure: Determination of the dft Index (decay filled teeth index) of the subgroups
timeFrame: 3rd Month
measure: A questionnaire consisting of 19 questions that all children participating in the study could answer with their parents.
timeFrame: Baseline
Other outcomes:
Locations:
city: Aydın
country: Turkey
facility: Aydın Adnan Menderes University Faculty of Dentistry Department of Pediatric Dentistry
Study officials:
affiliation: Aydın Adnan Menderes University, Turkey
name: Bahar Melis AKYILDIZ
role: STUDY_DIRECTOR
affiliation: Aydın Adnan Menderes University, Turkey
name: Zeynep UÇAR
role: PRINCIPAL_INVESTIGATOR
affiliation: Aydın Adnan Menderes University, Turkey
name: Aylin Kaya
role: PRINCIPAL_INVESTIGATOR
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