Attention Deficit and Hyperactivity DisorderNCT05935254
Plaque Removal Efficacy of Electric Toothbrushes in ADHD
A study testing 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) in people with Attention Deficit and Hyperactivity Disorder and Dental Plaque, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 8 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit and Hyperactivity Disorder, Dental Plaque
- What is being tested?
- 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)
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 Jan 2022to 15 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- Have a complex medical history
- Have psychiatric illness other than attention deficit and hyperactivity disorder
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Aydın Adnan Menderes University Faculty of Dentistry Department of Pediatric Dentistry
Aydin, 09100
About this study
Official title: Comparative Evaluation of Plaque Removal Efficacy of Electric Toothbrushes Between Children With Attention Deficit And Hyperactivity Disorder And Healthy Children
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.
Read the 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.
- Being tested
- Plaque removal efficacy of children's electric toothbrush (Oral-B D100 Vitality; Procter & Gamble, Cincinnati, OH, United States), Plaque removal efficacy of children's soft manual toothbrush (Oral-B Stages 6-12 years; Procter & Gamble, Cincinnati, OH, United States)
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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 Receives: 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 Receives: Device: Plaque removal efficacy of children's soft manual toothbrush (Oral-B Stages 6-12 years; Procter & Gamble, Cincinnati, OH, United States) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of Gingival Index (GI) values
Evaluation of children's gingival health during the study period
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
To determine the risk of dental caries in the permanent dentition period of children during the study period.
Measured: Baseline
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.
Measured: 3rd Month
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.
Measured: Baseline
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.
Measured: 3rd Month
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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2023
- Study start29 Jan 2022
- Primary completion20 Sep 2022
- Study completion15 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (49)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit and Hyperactivity DisorderStudies of the same condition, open and under way.
- More trials run by Aydin Adnan Menderes UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melis AKYILDIZ, Aydin Adnan Menderes University
- Investigators
- Bahar Melis AKYILDIZ, Study director, Aydın Adnan Menderes University, TurkeyZeynep UÇAR, Principal investigator, Aydın Adnan Menderes University, TurkeyAylin Kaya, Principal investigator, Aydın Adnan Menderes University, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05935254
- Sponsor's protocol ID
- AdnanMU-ZUCAR.001
- Status last verified
- Jul 2023
- First submitted
- 6 Mar 2023
- Last updated
- 7 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Polanczyk GV, Salum GA, Sugaya LS, Caye A, Rohde LA. Annual research review: A meta-analysis of the worldwide prevalence of mental disorders in children and adolescents. J Child Psychol Psychiatry. 2015 Mar;56(3):345-65. doi: 10.1111/jcpp.12381. Epub 2015 Feb 3.
PubMed 25649325Drumond VZ, Souza GLN, Pereira MJC, Mesquita RA, Amin M, Abreu LG. Dental Caries in Children with Attention Deficit/Hyperactivity Disorder: A Meta-Analysis. Caries Res. 2022;56(1):3-14. doi: 10.1159/000521142. Epub 2021 Dec 20.
PubMed 34929707Paszynska E, Krahel A, Pawinska M, Dmitrzak-Weglarz M, Perczak A, Slopien A, Gawriolek M. Management for Caries Prevention in ADHD Children. Int J Environ Res Public Health. 2022 Jun 17;19(12):7455. doi: 10.3390/ijerph19127455.
PubMed 35742701Atmetlla G, Burgos V, Carrillo A, Chaskel R. Behavior and orofacial characteristics of children with attention-deficit hyperactivity disorder during a dental visit. J Clin Pediatr Dent. 2006 Spring;30(3):183-90. doi: 10.17796/jcpd.30.3.g66h2750h11242p6.
PubMed 16683663Pirila-Parkkinen K, Pirttiniemi P, Nieminen P, Tolonen U, Pelttari U, Lopponen H. Dental arch morphology in children with sleep-disordered breathing. Eur J Orthod. 2009 Apr;31(2):160-7. doi: 10.1093/ejo/cjn061. Epub 2008 Nov 20.
PubMed 19028674Andersson H, Sonnesen L. Sleepiness, occlusion, dental arch and palatal dimensions in children attention deficit hyperactivity disorder (ADHD). Eur Arch Paediatr Dent. 2018 Apr;19(2):91-97. doi: 10.1007/s40368-018-0330-3. Epub 2018 Mar 14.
PubMed 29542042Avsar A, Akbas S, Ataibis T. Traumatic dental injuries in children with attention deficit/hyperactivity disorder. Dent Traumatol. 2009 Oct;25(5):484-9. doi: 10.1111/j.1600-9657.2009.00792.x. Epub 2009 Jun 1.
PubMed 19496799Blomqvist M, Holmberg K, Fernell E, Dahllof G. A retrospective study of dental behavior management problems in children with attention and learning problems. Eur J Oral Sci. 2004 Oct;112(5):406-11. doi: 10.1111/j.1600-0722.2004.00150.x.
PubMed 15458498Sujlana A, Dang R. Dental care for children with attention deficit hyperactivity disorder. J Dent Child (Chic). 2013 May-Aug;80(2):67-70.
PubMed 24011294Marsh PD. Dental plaque: biological significance of a biofilm and community life-style. J Clin Periodontol. 2005;32 Suppl 6:7-15. doi: 10.1111/j.1600-051X.2005.00790.x.
PubMed 16128825Nishihara T, Koseki T. Microbial etiology of periodontitis. Periodontol 2000. 2004;36:14-26. doi: 10.1111/j.1600-0757.2004.03671.x. No abstract available.
PubMed 15330940Schmidt JC, Zaugg C, Weiger R, Walter C. Brushing without brushing?--a review of the efficacy of powered toothbrushes in noncontact biofilm removal. Clin Oral Investig. 2013 Apr;17(3):687-709. doi: 10.1007/s00784-012-0836-8. Epub 2012 Sep 23.
PubMed 23001187Turgut MD, Keceli TI, Tezel B, Cehreli ZC, Dolgun A, Tekcicek M. Number, length and end-rounding quality of bristles in manual child and adult toothbrushes. Int J Paediatr Dent. 2011 May;21(3):232-9. doi: 10.1111/j.1365-263X.2010.01102.x. Epub 2010 Oct 21.
PubMed 20961341Slot DE, Wiggelinkhuizen L, Rosema NA, Van der Weijden GA. The efficacy of manual toothbrushes following a brushing exercise: a systematic review. Int J Dent Hyg. 2012 Aug;10(3):187-97. doi: 10.1111/j.1601-5037.2012.00557.x. Epub 2012 Jun 6.
PubMed 22672101Thomassen TMJA, Van der Weijden FGA, Slot DE. The efficacy of powered toothbrushes: A systematic review and network meta-analysis. Int J Dent Hyg. 2022 Feb;20(1):3-17. doi: 10.1111/idh.12563. Epub 2021 Dec 31.
PubMed 34877772
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Plaque Removal Efficacy of Electric Toothbrushes Between Children With Attention Deficit And Hyperactivity Disorder And Healthy Children
- ClinicalTrials.gov ID
- NCT05935254
- Acronym / sponsor ID
- AdnanMU-ZUCAR.001
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- 29 Jan 2022 (actual)
- Primary completion
- 20 Sep 2022 (actual)
- Study completion
- 15 Dec 2022 (actual)
- First posted
- 7 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ADHD-Electric Toothbrush Group | Experimental | Device: Plaque removal efficacy of children's electric toothbrush (Oral-B D100 Vitality; Procter & Gamble, Cincinnati, OH, United States)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. |
| ADHD-Manual Toothbrush Group | Experimental | Device: Plaque removal efficacy of children's soft manual toothbrush (Oral-B Stages 6-12 years; Procter & Gamble, Cincinnati, OH, United States)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. |
| Healthy- Electric Toothbrush Group | Active comparator | Device: Plaque removal efficacy of children's electric toothbrush (Oral-B D100 Vitality; Procter & Gamble, Cincinnati, OH, United States)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 |
| Healthy- Manual Toothbrush Group | Active comparator | Device: Plaque removal efficacy of children's soft manual toothbrush (Oral-B Stages 6-12 years; Procter & Gamble, Cincinnati, OH, United States)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 |
Who may qualify
- Ages
- 8 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- Have a complex medical history
- Have psychiatric illness other than attention deficit and hyperactivity disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | 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)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. | Device | ADHD-Manual Toothbrush Group, Healthy- Manual Toothbrush Group |
Primary outcome
Determination of Gingival Index (GI) values
Time frame: The measurements will be done before the intervention at baseline
Evaluation of children's gingival health during the study period
Determination of Gingival Index (GI) values
Time frame: The measurements will be done before the intervention at 1st month
Evaluation of children's gingival health during the study period
Determination of Gingival Index (GI) values
Time frame: The measurements will be done before the intervention at 3rd month
Evaluation of children's gingival health during the study period
Determination of Turesky modification of Quigley-Hein Plaque Index (TQHPI) values
Time frame: The measurements will be done immediately before the intervention at baseline
Evaluation of plaque removal efficiency from labial and lingual surfaces of teeth with a toothbrush
Determination of Turesky modification of Quigley-Hein Plaque Index (TQHPI) values
Time frame: The measurements will be done immediately after the intervention at baseline
Evaluation of plaque removal efficiency from labial and lingual surfaces of teeth with a toothbrush
Determination of Turesky modification of Quigley-Hein Plaque Index (TQHPI) values
Time frame: The measurements will be done immediately before the intervention at 1st month
Evaluation of plaque removal efficiency from labial and lingual surfaces of teeth with a toothbrush
Determination of Turesky modification of Quigley-Hein Plaque Index (TQHPI) values
Time frame: The measurements will be done immediately after the intervention at 1st month
Evaluation of plaque removal efficiency from labial and lingual surfaces of teeth with a toothbrush
Determination of Turesky modification of Quigley-Hein Plaque Index (TQHPI) values
Time frame: The measurements will be done immediately before the intervention at 3rd month
Evaluation of plaque removal efficiency from labial and lingual surfaces of teeth with a toothbrush
Determination of Turesky modification of Quigley-Hein Plaque Index (TQHPI) values
Time frame: The measurements will be done immediately after the intervention at 3rd month
Evaluation of plaque removal efficiency from labial and lingual surfaces of teeth with a toothbrush
Determination of Approximal Plaque Index (API) values
Time frame: The measurements will be done immediately before the intervention at baseline
Evaluation of plaque removal efficiency from proximal surfaces of teeth with a toothbrush
Determination of Approximal Plaque Index (API) values
Time frame: The measurements will be done immediately after the intervention at baseline
Evaluation of plaque removal efficiency from proximal surfaces of teeth with a toothbrush
Determination of Approximal Plaque Index (API) values
Time frame: The measurements will be done immediately before the intervention at 1st month
Evaluation of plaque removal efficiency from proximal surfaces of teeth with a toothbrush
Determination of Approximal Plaque Index (API) values
Time frame: The measurements will be done immediately after the intervention at 1st month
Evaluation of plaque removal efficiency from proximal surfaces of teeth with a toothbrush
Determination of Approximal Plaque Index (API) values
Time frame: The measurements will be done immediately before the intervention at 3rd month
Evaluation of plaque removal efficiency from proximal surfaces of teeth with a toothbrush
Determination of Approximal Plaque Index (API) values
Time frame: The measurements will be done immediately after the intervention at 3rd month
Evaluation of plaque removal efficiency from proximal surfaces of teeth with a toothbrush
5 secondary outcomes
Determination of the DMFT Index (Decayed, Missing and filled Teeth Index) of the subgroups
Time frame: Baseline
Determination of the DMFT Index (Decayed, Missing and filled Teeth Index) of the subgroups
Time frame: 3rd Month
Determination of the dft Index (decay filled teeth index) of the subgroups
Time frame: Baseline
Determination of the dft Index (decay filled teeth index) of the subgroups
Time frame: 3rd Month
A questionnaire consisting of 19 questions that all children participating in the study could answer with their parents.
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2023.
- Background: PubMed 25649325Polanczyk GV, Salum GA, Sugaya LS, Caye A, Rohde LA. Annual research review: A meta-analysis of the worldwide prevalence of mental disorders in children and adolescents. J Child Psychol Psychiatry. 2015 Mar;56(3):345-65. doi: 10.1111/jcpp.12381. Epub 2015 Feb 3.
- Background: PubMed 34929707Drumond VZ, Souza GLN, Pereira MJC, Mesquita RA, Amin M, Abreu LG. Dental Caries in Children with Attention Deficit/Hyperactivity Disorder: A Meta-Analysis. Caries Res. 2022;56(1):3-14. doi: 10.1159/000521142. Epub 2021 Dec 20.
- Background: PubMed 35742701Paszynska E, Krahel A, Pawinska M, Dmitrzak-Weglarz M, Perczak A, Slopien A, Gawriolek M. Management for Caries Prevention in ADHD Children. Int J Environ Res Public Health. 2022 Jun 17;19(12):7455. doi: 10.3390/ijerph19127455.
- Background: PubMed 16683663Atmetlla G, Burgos V, Carrillo A, Chaskel R. Behavior and orofacial characteristics of children with attention-deficit hyperactivity disorder during a dental visit. J Clin Pediatr Dent. 2006 Spring;30(3):183-90. doi: 10.17796/jcpd.30.3.g66h2750h11242p6.
- Background: PubMed 19028674Pirila-Parkkinen K, Pirttiniemi P, Nieminen P, Tolonen U, Pelttari U, Lopponen H. Dental arch morphology in children with sleep-disordered breathing. Eur J Orthod. 2009 Apr;31(2):160-7. doi: 10.1093/ejo/cjn061. Epub 2008 Nov 20.
- Background: PubMed 29542042Andersson H, Sonnesen L. Sleepiness, occlusion, dental arch and palatal dimensions in children attention deficit hyperactivity disorder (ADHD). Eur Arch Paediatr Dent. 2018 Apr;19(2):91-97. doi: 10.1007/s40368-018-0330-3. Epub 2018 Mar 14.
- Background: PubMed 19496799Avsar A, Akbas S, Ataibis T. Traumatic dental injuries in children with attention deficit/hyperactivity disorder. Dent Traumatol. 2009 Oct;25(5):484-9. doi: 10.1111/j.1600-9657.2009.00792.x. Epub 2009 Jun 1.
- Background: PubMed 15458498Blomqvist M, Holmberg K, Fernell E, Dahllof G. A retrospective study of dental behavior management problems in children with attention and learning problems. Eur J Oral Sci. 2004 Oct;112(5):406-11. doi: 10.1111/j.1600-0722.2004.00150.x.
- Background: PubMed 24011294Sujlana A, Dang R. Dental care for children with attention deficit hyperactivity disorder. J Dent Child (Chic). 2013 May-Aug;80(2):67-70.
- Background: PubMed 16128825Marsh PD. Dental plaque: biological significance of a biofilm and community life-style. J Clin Periodontol. 2005;32 Suppl 6:7-15. doi: 10.1111/j.1600-051X.2005.00790.x.
- Background: PubMed 15330940Nishihara T, Koseki T. Microbial etiology of periodontitis. Periodontol 2000. 2004;36:14-26. doi: 10.1111/j.1600-0757.2004.03671.x. No abstract available.
- Background: PubMed 23001187Schmidt JC, Zaugg C, Weiger R, Walter C. Brushing without brushing?--a review of the efficacy of powered toothbrushes in noncontact biofilm removal. Clin Oral Investig. 2013 Apr;17(3):687-709. doi: 10.1007/s00784-012-0836-8. Epub 2012 Sep 23.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bahar Melis AKYILDIZ study director
Aydın Adnan Menderes University, Turkey
Zeynep UÇAR principal investigator
Aydın Adnan Menderes University, Turkey
Aylin Kaya principal investigator
Aydın Adnan Menderes University, Turkey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 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) in people with Attention Deficit and Hyperactivity Disorder and Dental Plaque, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of Gingival Index (GI) values (time frame: The measurements will be done before the intervention at baseline). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05935254, which also lists 49 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2023.