CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 52 enrolled
Drug / intervention
Plaque removal efficacy of children's electric toothbrush (Oral-B D100 Vitality; Procter & Gamble, Cincinnati, OH, United States) +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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Search/NCT05935254
NCT05935254N/ACompleted

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

Aydin Adnan Menderes University·interventional·Posted Jul 7, 2023·Updated Jul 7, 2023

In Brief

A clinical study evaluating Plaque removal efficacy of children's electric toothbrush (Oral-B D100 Vitality; Procter & Gamble, Cincinnati, OH, United States) and Plaque removal efficacy of children's soft manual toothbrush (Oral-B Stages 6-12 years; Procter & Gamble, Cincinnati, OH, United States) for Attention Deficit and Hyperactivity Disorder and Dental Plaque. Completed, enrolled 52 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesTurkey (Türkiye)
Collaborators--

Timeline

N/ACompletedFinished
20222023202420252026
First PostedJul 7, 2023
Enrollment StartJan 29, 2022
Primary CompletionSep 20, 2022
Study CompletionDec 15, 2022
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 3.0 years ago

Interventions

Plaque removal efficacy of children's electric toothbrush (Oral-B D100 Vitality; Procter & Gamble, Cincinnati, OH, United States)device

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)device

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.