Ignite Creation Date:
2024-05-06 @ 7:49 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06140459
Status:
COMPLETED
Last Update Posted:
2023-11-28
First Post:
2023-11-06
Brief Title:
The Effectiveness of Conventional and Pulsating Toothbrushes on Mentally Disabled Children
Sponsor:
Antalya Bilim University
Organization:
Antalya Bilim University
Study Overview
Official Title:
The Evaluation of the Effectiveness of Conventional and Pulsating Toothbrushes on Oral Health of Healthy and Mentally Disabled Pediatric Patients
Status:
COMPLETED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 GV OHI-S measurements are performed and used to evaluate the oral hygiene status
Detailed Description:
Ages between 7-12 mean age 1114108 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 childrens 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 childrens 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 GV Simplified Oral Hygiene Index GV OHI-S Green and Vermillion Oral Hygiene Index-Simplified1964 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 ProcterGamble No35 Colgate 360º Micro Sonic Power Colgate-Palmolive and Oral-B Stages 3 ProcterGamble
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 GV 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 hisher own for 2 minutes 1 minute after brushing the teeth determined in Green and Vermillion oral hygiene index GV OHI-S were repainted with Mira-2-Ton plaque staining solution The child was asked to rinse hisher 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 childrens 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 GV OHI-S were measured Measurements were recorded on charts Then brushing was done and Green and Vermillion oral hygiene index GV OHI-S was repeated post-brushing The childrens 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
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 childrens 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 childrens 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 GV Simplified Oral Hygiene Index GV OHI-S Green and Vermillion Oral Hygiene Index-Simplified1964 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 ProcterGamble No35 Colgate 360º Micro Sonic Power Colgate-Palmolive and Oral-B Stages 3 ProcterGamble
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 GV 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 hisher own for 2 minutes 1 minute after brushing the teeth determined in Green and Vermillion oral hygiene index GV OHI-S were repainted with Mira-2-Ton plaque staining solution The child was asked to rinse hisher 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 childrens 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 GV OHI-S were measured Measurements were recorded on charts Then brushing was done and Green and Vermillion oral hygiene index GV OHI-S was repeated post-brushing The childrens 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None