Plaque Removal Efficacy of Electric Toothbrushes in ADHD

NCT05935254 | Completed

• 1 other identifier: AdnanMU-ZUCAR.001
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Attention Deficit and Hyperactivity Disorder; Dental Plaque

Outcome Measures

Primary Outcomes (15)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (5)

• Determination of the DMFT Index (Decayed, Missing and filled Teeth Index) of the subgroups

  Baseline

• Determination of the DMFT Index (Decayed, Missing and filled Teeth Index) of the subgroups

  3rd Month

• Determination of the dft Index (decay filled teeth index) of the subgroups

  Baseline

• Determination of the dft Index (decay filled teeth index) of the subgroups

  3rd Month

• A questionnaire consisting of 19 questions that all children participating in the study could answer with their parents.

  Baseline

Study Arms (4)

ADHD-Electric Toothbrush Group

EXPERIMENTAL

Children aged 8-10 years who were diagnosed with Attention Deficit Hyperactivity Disorder (ADHD) according to DSM-5 criteria, who applied to Aydın Adnan Menderes University Faculty of Medicine Child Psychiatry Clinic, were randomly assigned to the electric toothbrush group.

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

ADHD-Manual Toothbrush Group

EXPERIMENTAL

Children aged 8-10 years who were diagnosed with Attention Deficit Hyperactivity Disorder (ADHD) according to DSM-5 criteria, who applied to Aydın Adnan Menderes University Faculty of Medicine Child Psychiatry Clinic, were randomly assigned to the manual toothbrush group.

Device: Plaque removal efficacy of children's soft manual toothbrush (Oral-B Stages 6-12 years; Procter & Gamble, Cincinnati, OH, United States)

Healthy- Electric Toothbrush Group

ACTIVE COMPARATOR

Among the physically and psychologically healthy children aged 8-10 who applied to the Pediatric Dentistry Clinic of ADU Faculty of Dentistry, those assigned to the electric toothbrush group as a result of randomization

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

Healthy- Manual Toothbrush Group

ACTIVE COMPARATOR

Among the physically and psychologically healthy children aged 8-10 who applied to the Pediatric Dentistry Clinic of ADU Faculty of Dentistry, those assigned to the manual toothbrush group as a result of randomization

Device: Plaque removal efficacy of children's soft manual toothbrush (Oral-B Stages 6-12 years; Procter & Gamble, Cincinnati, OH, United States)

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.

ADHD-Electric Toothbrush Group; Healthy- Electric Toothbrush Group

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.

ADHD-Manual Toothbrush Group; Healthy- Manual Toothbrush Group

Eligibility Criteria

• Age: 8 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Have a complex medical history
• Have psychiatric illness other than attention deficit and hyperactivity disorder

Sponsors & Collaborators

• Aydin Adnan Menderes University: lead

Study Sites (1)

Aydın Adnan Menderes University Faculty of Dentistry Department of Pediatric Dentistry

Aydin, 09100, Turkey (Türkiye)

Location

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MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Dental Plaque

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Dental Deposits; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Bahar Melis AKYILDIZ

  Aydın Adnan Menderes University, Turkey

  STUDY DIRECTOR

• Zeynep UÇAR

  Aydın Adnan Menderes University, Turkey

  PRINCIPAL INVESTIGATOR

• Aylin Kaya

  Aydın Adnan Menderes University, Turkey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor Bahar Melis AKYILDIZ

Study Record Dates

• First Submitted: March 6, 2023
• First Posted: July 7, 2023
• Study Start: January 29, 2022
• Primary Completion: September 20, 2022
• Study Completion: December 15, 2022
• Last Updated: July 7, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)