The Effectiveness of Conventional and Pulsating Toothbrushes on Mentally Disabled Children

NCT06140459 | Completed

• 1 other identifier: REF: 29601
• Study Type: interventional
• Target: 62
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Periodontal Indexes

Keywords

Mentally disabled children; plaque removal; conventional toothbrush; pulsating toothbrush; plaque index

Outcome Measures

Primary Outcomes (3)

• Modified Sulcus Bleeding Index (MOD-SBI)

  In control with a periodontal probe; It was determined whether there was bleeding in the oral gums of the 1st and 3rd half jaws and in the facial side gums of the 2nd and 4th half jaws. The status was charted as Yes (+) in the presence of bleeding and No (-) in the absence of bleeding. The result was calculated as a percentage.

  First visit, first month, third month, fifth month

• Approximal plaque index (API)

  Half jaws numbered 1 and 3 were evaluated from their oral surfaces, and semi jaws numbered 2 and 4 were evaluated from their facial surfaces. Whether there is only plaque or not is marked on the diagram as Yes (+), No (-). The plaque index value was calculated as a percentage (%).

  First visit, first month, third month, fifth month

• Green and Vermillion oral hygiene index (G&V OHI-S)

  For Green and Vermilion oral hygiene measurement, 2 drops of Mira-2-Ton plaque staining solution are dropped into plastic disposable cups and with the help of a brush, it was applied to the teeth. The child's mouth was rinsed with water for 30 seconds and the stained surface areas were evaluated after one minute. Measurements were made from the buccal surfaces of teeth 16 and 26, the lingual surfaces of teeth 36 and 46, and the labial surfaces of teeth 11 and 31. The amount of plaque was graded with 4 separate scores from 0 to 3, depending on the size of the surface area stained with the staining solution. The index was calculated by dividing the total values by the number of surfaces.

  first visit pre-brushing, first visit post-brushing, first month pre-brushing, first month post-brushing, , third month pre-brushing, third month post-brushing, fifth month pre-brushing, fifth month post-brushing

Study Arms (2)

Disabled children

EXPERIMENTAL

Special education school students

Device: Conventional Toothbrushes; Device: Pulsating Toothbrushes

Healthy children

ACTIVE COMPARATOR

Systemically healthy school children

Device: Conventional Toothbrushes; Device: Pulsating Toothbrushes

Interventions

Conventional Toothbrushes DEVICE

Oral-B Stages 3

Disabled children; Healthy children

Pulsating Toothbrushes DEVICE

Oral-B Pulsar, Colgate 360º Micro Sonic Power

Disabled children; Healthy children

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• not use antibiotics
• not to have received an additional plaque control application in the previous 5 months
• have at least 20 teeth in their mouths
• not to receive orthodontic treatment
• For Group 1 to have an intelligence level close to the average for disabled children
• For Group 2 systemically healthy
• to be capable of brushing on their own

You may not qualify if:

• non-cooperative

Sponsors & Collaborators

• Antalya Bilim University: lead

Related Publications (6)

• Zhou N, Wong HM, McGrath C. Oral health and associated factors among preschool children with special healthcare needs. Oral Dis. 2019 May;25(4):1221-1228. doi: 10.1111/odi.13057. Epub 2019 Feb 21.

  PMID: 30725497 BACKGROUND

• Petrukhina NB, Boriskina OA, Shevlyakov DI. [Clinical analysis of the cleaning effectiveness of toothbrushes of various types in children aged 6-15 years after a single brushing]. Stomatologiia (Mosk). 2021;100(6):76-81. doi: 10.17116/stomat202110006176. Russian.

  PMID: 34953193 BACKGROUND

• Zhou N, Wong HM, McGrath C. The Impact of Adaptive Functioning and Oral Hygiene Practices on Observed Tooth-Brushing Performance Among Preschool Children with Special Health Care Needs. Matern Child Health J. 2019 Dec;23(12):1587-1594. doi: 10.1007/s10995-019-02813-5.

  PMID: 31552578 BACKGROUND

• Dogan MC, Alacam A, Asici N, Odabas M, Seydaoglu G. Clinical evaluation of the plaque-removing ability of three different toothbrushes in a mentally disabled group. Acta Odontol Scand. 2004 Dec;62(6):350-4. doi: 10.1080/00016350410010054.

  PMID: 15848980 BACKGROUND

• Escribano Hernandez A, Hernandez Corral T, Ruiz-Martin E, Porteros Sanchez JA. Results of a dental care protocol for mentally handicapped patients set in a primary health care area in Spain. Med Oral Patol Oral Cir Bucal. 2007 Nov 1;12(7):E492-5.

  PMID: 17978772 BACKGROUND

• Biesbrock AR, Bartizek RD, Walters PA. Improved plaque removal efficacy with a new manual toothbrush. J Contemp Dent Pract. 2008 May 1;9(4):1-8.

  PMID: 18473021 BACKGROUND

Study Officials

• Işın Ulukapı, Prof.

  Okan University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Model Details: 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.

Study Record Dates

• First Submitted: November 6, 2023
• First Posted: November 20, 2023
• Study Start: October 1, 2008
• Primary Completion: March 31, 2009
• Study Completion: March 31, 2009
• Last Updated: November 28, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share