The Effectiveness of Conventional and Pulsating Toothbrushes on Mentally Disabled Children
Condition: Periodontal Indexes
Study type: Interventional

Summary: 
      Children, especially the mentally disabled, are generally incapable of obtaining an adequate
      oral hygiene level by manual brushing because of their lack of knowledge about oral hygiene
      and their limited motor skills. To handle those limited skills different designs of manual
      and electric toothbrushes are developed and put on the market. This study aimed to evaluate
      the effectiveness of pulsating toothbrushes with easy-to-use properties against conventional
      toothbrushes and to analyze their benefits on mentally disabled pediatric patients. 31
      healthy and 31 mentally disabled children (aged between 7-12) participated in this study. The
      effectiveness of three different toothbrushes (Oral-B Pulsar, Colgate 360º Micro Sonic Power,
      Oral-B Stages 3) was investigated with a cross-over study design. DMFT, dft, modified sulcus
      bleeding index (MOD-SBI), approximal plaque index (API) and Green and Vermillion simplified
      oral hygiene index (G&V OHI-S) measurements are performed and used to evaluate the oral
      hygiene status.
    

Detailed description: 
      Ages between 7-12 (mean age 11.14±1.08), 31 healthy (17 girls, 14 boys) and 31 educable
      mentally disabled (12 girls, 19 boys) (special education school students), a total of 62
      children were included in the study, following the ethics committee approval (REF: 29601).

      Patient selection The children in the experimental group were educable mental disabled
      children (special education school students) and the control group systemically healthy
      children (primary school students). The children participating in the study were required not
      to use antibiotics, not to have received an additional plaque control application in the
      previous 5 months, to have at least 20 teeth in their mouths and not to receive orthodontic
      treatment, to have an intelligence level close to the average for disabled children, and to
      be capable of brushing on their own. Children in the study group were informed not to perform
      different oral hygiene practices such as mouthwash and dental floss during the study.

      A preliminary meeting was held with the children's parents and they were informed verbally
      and in writing about the content of the study. For this purpose, a voluntary consent form was
      signed, including the content of the study, duration of participation, potential risks and
      problems, possible benefits for the patient, address, and telephone information of the parent
      and the child. One-on-one interviews were held with the children's parents, questions were
      asked about their general health conditions, and records were taken.

      Clinical Evaluation Oral and dental examinations of children were performed with the help of
      a mirror and probe according to the World Health Organization criteria. If any surface of the
      tooth became visible in the mouth, the tooth was considered erupted. If both primary and
      permanent teeth were in the same tooth space at the same time, permanent teeth were included
      in the evaluation. DMFT values for permanent teeth and dft values for primary teeth were
      calculated according to the DMFT index (Decayed, Missing, and Filled Teeth Index). To
      determine oral hygiene, G&V Simplified Oral Hygiene Index [G&V OHI-S (Green and Vermillion
      Oral Hygiene Index-Simplified,1964)], Modified Sulcus Bleeding Index (MOD-SBI) and Aproximal
      Plaque Index (API) were used. The amount of plaque was measured by staining method from
      different surfaces of six teeth, two from the anterior area and four from the posterior area.
      At the beginning of each experimental period, children were instructed not to brush their
      teeth for 24 hours. Bleeding status was evaluated by applying the Modified Sulcus Bleeding
      Index within the clinical examination before brushing on the test day and control
      appointments. The plaque was stained with Mira-2-tone plaque staining solution pre and
      post-brushing during each examination period, and the stained plaque was shown to the child.

      Each child was taught individually how to brush using the Bass Technique, first on the model
      and then in front of the mirror. Children were instructed to brush themselves for 2 minutes
      twice a day, after breakfast and in the evening before going to bed. Families were informed
      with written documents to follow up the brushing. To ensure the accuracy of the brushing
      time, 2-minute hourglasses were given to all children at the beginning of the study, and the
      families of disabled children were specifically warned to monitor the time. Cards prepared to
      mark brushings were sent to families. During the study, toothpaste was sent to the children
      for brushing with a single type of toothpaste (Ipana Complete 7 Care System Night-Procter &
      Gamble).

      Three different types and brands of commercially available toothbrushes (two with pulsating
      features and one conventional) were used in the study. The three toothbrushes were Oral-B
      Pulsar (Procter&Gamble) (No:35), Colgate 360º Micro Sonic Power (Colgate-Palmolive), and
      Oral-B Stages 3 (Procter&Gamble).

      Application Procedure Parents ensured that the children did not brush their teeth 24 hours
      before starting the study. The children included in the study were examined at their schools.
      Decayed, filled, missing, and existing teeth were detected and recorded in the oral follow-up
      form. Each child was taught individually how to brush using the Bass Technique, first on the
      model and then in front of the mirror. On the first day of the test period, Modified Sulcus
      Bleeding Index (MOD-SBI), approximal plaque index (API), and Green and Vermillion oral
      hygiene index (G&V OHI-S) were measured. For Green and Vermilion oral hygiene measurement, 2
      drops of Mira-2-Ton plaque staining solution were used, and with the help of a brush it was
      applied to the teeth. The children rinsed their mouths with water for 30 seconds and the
      stained surface areas were evaluated after one minute. The results were recorded in the
      charts on the oral follow-up form. Then, group 1 toothbrush (Oral-B Pulsar) and toothpaste
      were given and the child was allowed to brush on his/her own for 2 minutes. 1 minute after
      brushing, the teeth determined in Green and Vermillion oral hygiene index (G&V OHI-S) were
      repainted with Mira-2-Ton plaque staining solution. The child was asked to rinse his/her
      mouth with water for 30 seconds. The stained surfaces were examined and plaque levels were
      recorded on the forms. The first group of toothbrushes, one toothpaste, a brushing tracking
      card, an hourglass, and a parent information letter were sent to the children's homes. For a
      month, the children used the toothpaste sent with the 1st group toothbrush, twice a day
      (after breakfast in the morning, before going to bed in the evening) at home, on their own,
      under their parents' control that they were brushing and marking it on the cards. At the end
      of one month, the children were asked to bring their toothbrushes and follow-up cards to
      school with them and not to brush for 24 hours before. Intraoral examinations of the children
      (soft and hard tissues, lips, tongue, sublingual area, inner parts of the cheeks, hard and
      soft palate, and buccal mucosa folds were evaluated), and caries were detected and marked on
      the oral follow-up form), Modified Sulcus Bleeding Index (MOD-SBI), approximal plaque index
      (API), and Green and Vermillion oral hygiene index (G&V OHI-S) were measured. Measurements
      were recorded on charts. Then, brushing was done and Green and Vermillion oral hygiene index
      (G&V OHI-S) was repeated post-brushing. The children's toothbrushes were taken back, a break
      was given for a month, and they were asked to brush with a small-headed, simple-designed
      manual toothbrush that was not included in the study, in order for the children to return to
      their old brushing habits. After a one-month break, the applications were continued with the
      2nd (Colgate 360º Micro Sonic Battery-Powered Toothbrush) and 3rd (Oral-B Stages)
      toothbrushes, respectively, following the same procedures. The study ended in a total of five
      months, with an experimental period in which each participant used all three brushes for one
      month and a one-month interim period between each brush for the children to return to their
      old habits.
    

Intervention name(s): Conventional Toothbrushes; Pulsating Toothbrushes
Intervention type(s): Device; Device
Intervention description(s): Oral-B Stages 3; Oral-B Pulsar, Colgate 360º Micro Sonic Power
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Intervention model description: Each subject can be evaluated as its own control; the number of samples is generally less than in studies designed as comparative parallel groups. Crossover design studies ensure that each patient can use each type of toothbrush. In this study, for the results to be reliable, a crossover design was used to ensure that all participants used each brush.
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Mentally disabled children; plaque removal; conventional toothbrush; pulsating toothbrush; plaque index