Ignite Creation Date:
2024-05-06 @ 8:59 AM
Last Modification Date:
2024-10-26 @ 12:08 PM
Study NCT ID:
NCT02877888
Status:
COMPLETED
Last Update Posted:
2018-12-12
First Post:
2016-08-11
Brief Title:
Effectiveness of Fluoride Varnish in Prevention of Dental Caries in School Children
Sponsor:
University of Peradeniya
Organization:
University of Peradeniya
Study Overview
Official Title:
A Randomised Controlled Trial to Measure Effectiveness of Sodium Fluoride Varnish to Prevent Dental Caries in School Children Between Age of 6 and 7 Years
Status:
COMPLETED
Status Verified Date:
2018-12
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:
Despite the availability of free health dental service in Sri Lanka the prevalence and severity of dental caries among 6year old school children stand at a very high level according to the results of national oral health survey in 198384 9495 and 20022003 Professional fluoride varnish application has become popular as variety of studies has found that it is an efficient method in reducing dental caries The simplicity of its application makes it very suitable and practical for use in dental clinics and outreach dental services especially in young children
Aim of this study is to evaluate the cost effectiveness of 6 monthly application of sodium fluoride varnish in prevention of dental caries in permanent incisors and molars in children between 6 and 7 years in a suburban setting in Sri Lanka This will be a double-blind randomized controlled trial A sample of school children 6-7 years will be randomized into varnish and control groups All the children will receive routine caries preventive measures of oral hygiene instructions dietary advice and professional cleaning Children in varnish group will receive fluoride varnish professionally applied after prophylaxis every 6 months Clinical examinations of all children will be performed at the beginning of the study and 1 year and 2 years later All the caries at the dentinal level of both groups will be stabilized with temporary restorations at the beginning During this period each school will be visited four times at 6-month interval for recruitment dental examinations and fluoride varnish applications Recruited children will be randomly assigned to either a treatment 5 NaF varnish or a control group Caries examinations will be conducted using the International Caries Detection and Assessment System ICDAS The cost for the dental teams school visits cost involved in the treatment of dental caries throughout the course of the study in both groups will be evaluated and compared at the end of the study The sample size is calculated as 160 each arm to detect 5 caries change with 80 power Analysis The effect of intervention will be measured by number of caries prevented New caries in the usual care and intervention group will be calculated after the completion of the study The costs for intervention will be estimated The costs will be estimated for the dental material time for human resources and indirect costs
Aim of this study is to evaluate the cost effectiveness of 6 monthly application of sodium fluoride varnish in prevention of dental caries in permanent incisors and molars in children between 6 and 7 years in a suburban setting in Sri Lanka This will be a double-blind randomized controlled trial A sample of school children 6-7 years will be randomized into varnish and control groups All the children will receive routine caries preventive measures of oral hygiene instructions dietary advice and professional cleaning Children in varnish group will receive fluoride varnish professionally applied after prophylaxis every 6 months Clinical examinations of all children will be performed at the beginning of the study and 1 year and 2 years later All the caries at the dentinal level of both groups will be stabilized with temporary restorations at the beginning During this period each school will be visited four times at 6-month interval for recruitment dental examinations and fluoride varnish applications Recruited children will be randomly assigned to either a treatment 5 NaF varnish or a control group Caries examinations will be conducted using the International Caries Detection and Assessment System ICDAS The cost for the dental teams school visits cost involved in the treatment of dental caries throughout the course of the study in both groups will be evaluated and compared at the end of the study The sample size is calculated as 160 each arm to detect 5 caries change with 80 power Analysis The effect of intervention will be measured by number of caries prevented New caries in the usual care and intervention group will be calculated after the completion of the study The costs for intervention will be estimated The costs will be estimated for the dental material time for human resources and indirect costs
Detailed Description:
Background
Dental caries remains a significant public health problem with socioeconomic dietary and microbiological factors playing a major role as risk factors in initiation and progression of the disease It is the most common cause of toothache and hospital admissions in young children Dental caries in school children not only causes pain but also impacts school attendance parents work hours childrens ability to eat play and sleep Therefore dental caries when present significantly reduces the health related quality of life of a child
Evidence-based studies indicate oral health prevention is cost-effective and saves children from pain and lost days of schoolTherefore the measures taken to prevent the development of dental caries could include bacterial biofilm control dietary counselling fluoride toothpastes mouth rinses varnishes gels and foams and casein-derived remineralisation pastes and placing resin-basedglass-ionomer pit and fissure sealants Professional fluoride varnish application has become popular as variety of studies has discussed its effect in reducing dental caries
Fluoride varnish was incorporated into clinical dentistry to reduce caries its use in the US has increased progressively since it was approved by the FDA in 1994 Fluoride varnishs effectiveness in caries prevention ease of application and safety give it an advantage over other types of topical fluoride treatments such as gels and rinses or other caries management methods As a result it is regarded as one of the superior topical fluoride agents for young children Fluoride varnish also prolongs the contact time between fluoride and tooth surface to reduce caries Its active ingredient is usually 5 sodium fluoride or 22600 ppm fluoride It also has recently gained much attention in dentistry because the risk of dental fluorosis is also minimalThe simplicity of its application makes it very suitable and practical for use in dental clinics and outreach dental services especially in young children and in other special needs groups
Justification
Despite the availability of free health dental service in Sri Lanka the prevalence and severity of dental caries among six and seven years old school children in Sri Lanka stand at a very high level according to the results of national oral health survey in 198384 9495 and 20022003 The prevalence is 78 8384 764 9495 and 655 20022003 whereas the dmft is 44 41 and 36
The simplicity of its application makes it very suitable and practical for use in dental clinics and outreach dental services especially in young children and in other special needs groups
Up to date there is no other study carried out on cost effectiveness of fluoride varnish application on teeth in Sri Lankan population Therefore the results of the study will be beneficial in implementation and identification of advantages of fluoride varnish application on teeth in young children
Aim
the main objective of this study was to evaluate the effectiveness of six monthly application of sodium fluoride varnish in prevention of dental caries in deciduous teeth permanent incisors and molars in children between six and seven years in Sri Lanka
The specific objective is
1 To find out the association between dental caries and the social status of the child eg mothers education fathers education monthly family income etc
Methods
This was a double-blind randomized controlled trial The study has been registered with clinical trials registry NCT02877888
The study population was school children aged six to seven years living in Kurunegala district The inclusion and exclusion criteria used in the study are described below The study was conducted at Maliyadeva Adarsha Vidyalaya and Wayamba Royal college Kurunegala from month year to month year The sample was selected according to below criteria
Inclusion Criteria
Children with at least one permanent tooth present
Age 6 to 7 years Children under 6 years of age were enrolled in the study if at least one permanent tooth has erupted
Residing in Kurunegala municipal council region and tap water is consumed fluoride levels in drinking water was considered similar
Exclusion Criteria
Children with ulcerative gingivitis and stomatitis These children were referred for treatment
No permanent tooth present or stainless steel crowns only
The students meeting the inclusion and exclusion criteria was randomly assigned using block randomization in blocks of four using a computer generated set of random numbers to either varnish 5 Sodium Fluoride or control group A set of random numbers was used to create an allocation sequence which was contained in individual opaque envelopes for used by the chief investigator As the patients were recruited the next envelope in the sequence was opened and the student was assigned to the stated group All randomisation sequence generation and preparation of group allocation materials was performed by a third party who had no direct contact with the clinical aspects of the trial
The sample size was calculated as 160 each arm to detect 5 caries change with 80 power All children in both groups were provided with a self-administered pre tested questionnaire to assess the quality of life associated with presence of dental caries Further all the children received routine caries preventive measures of oral hygiene instructions dietary advice and professional cleaning Clinical examinations of all children were performed at the beginning of the study and 1 year and 2 years later All the caries at the dentinal level of both groups were stabilized with temporary restorations at the beginning Both varnish and control groups were subjected to use of fluoride tooth paste of 1000ppm Children in the intervention group received fluoride varnish professionally applied after prophylaxis every 6 months combined with counselling on maintenance of oral hygiene and diet for a period of 2 years The control group was only subjected to counselling on maintenance of oral hygiene and diet
During the period of two years a team visited each school four times at six months interval for recruitment dental examinations and fluoride varnish applications Trained interviewers collected data on oral health habits and sociodemographic characteristics of the children Caries examinations were conducted using the International Caries Detection and Assessment System ICDAS
The primary outcome studied was the number of new caries in the two study groups Students and the interviewers were blinded to the intervention varnish application or control and they were blinded to the hypothesis which was investigated in this study
Analysis
The mean number of caries between different groups segregated according to the variables assessed in the study were compared The mean number of caries in a particular group was calculated by dividing the total number of caries in a particular group by the total number of students in that group As the number of caries showed a skewed distribution Mann-Whitney U test was used compare the groups Level of significance was considered as p005
The effect of intervention was measured by the mean number of new caries in different groups The number of new caries in the usual care and intervention group was calculated at each time point of the survey The mean number of new caries between the two groups were compared using Mann-Whitney U test To assess the independent effect of the intervention on the incidence of caries when other factors are controlled multiple linear regression was applied
Dental caries remains a significant public health problem with socioeconomic dietary and microbiological factors playing a major role as risk factors in initiation and progression of the disease It is the most common cause of toothache and hospital admissions in young children Dental caries in school children not only causes pain but also impacts school attendance parents work hours childrens ability to eat play and sleep Therefore dental caries when present significantly reduces the health related quality of life of a child
Evidence-based studies indicate oral health prevention is cost-effective and saves children from pain and lost days of schoolTherefore the measures taken to prevent the development of dental caries could include bacterial biofilm control dietary counselling fluoride toothpastes mouth rinses varnishes gels and foams and casein-derived remineralisation pastes and placing resin-basedglass-ionomer pit and fissure sealants Professional fluoride varnish application has become popular as variety of studies has discussed its effect in reducing dental caries
Fluoride varnish was incorporated into clinical dentistry to reduce caries its use in the US has increased progressively since it was approved by the FDA in 1994 Fluoride varnishs effectiveness in caries prevention ease of application and safety give it an advantage over other types of topical fluoride treatments such as gels and rinses or other caries management methods As a result it is regarded as one of the superior topical fluoride agents for young children Fluoride varnish also prolongs the contact time between fluoride and tooth surface to reduce caries Its active ingredient is usually 5 sodium fluoride or 22600 ppm fluoride It also has recently gained much attention in dentistry because the risk of dental fluorosis is also minimalThe simplicity of its application makes it very suitable and practical for use in dental clinics and outreach dental services especially in young children and in other special needs groups
Justification
Despite the availability of free health dental service in Sri Lanka the prevalence and severity of dental caries among six and seven years old school children in Sri Lanka stand at a very high level according to the results of national oral health survey in 198384 9495 and 20022003 The prevalence is 78 8384 764 9495 and 655 20022003 whereas the dmft is 44 41 and 36
The simplicity of its application makes it very suitable and practical for use in dental clinics and outreach dental services especially in young children and in other special needs groups
Up to date there is no other study carried out on cost effectiveness of fluoride varnish application on teeth in Sri Lankan population Therefore the results of the study will be beneficial in implementation and identification of advantages of fluoride varnish application on teeth in young children
Aim
the main objective of this study was to evaluate the effectiveness of six monthly application of sodium fluoride varnish in prevention of dental caries in deciduous teeth permanent incisors and molars in children between six and seven years in Sri Lanka
The specific objective is
1 To find out the association between dental caries and the social status of the child eg mothers education fathers education monthly family income etc
Methods
This was a double-blind randomized controlled trial The study has been registered with clinical trials registry NCT02877888
The study population was school children aged six to seven years living in Kurunegala district The inclusion and exclusion criteria used in the study are described below The study was conducted at Maliyadeva Adarsha Vidyalaya and Wayamba Royal college Kurunegala from month year to month year The sample was selected according to below criteria
Inclusion Criteria
Children with at least one permanent tooth present
Age 6 to 7 years Children under 6 years of age were enrolled in the study if at least one permanent tooth has erupted
Residing in Kurunegala municipal council region and tap water is consumed fluoride levels in drinking water was considered similar
Exclusion Criteria
Children with ulcerative gingivitis and stomatitis These children were referred for treatment
No permanent tooth present or stainless steel crowns only
The students meeting the inclusion and exclusion criteria was randomly assigned using block randomization in blocks of four using a computer generated set of random numbers to either varnish 5 Sodium Fluoride or control group A set of random numbers was used to create an allocation sequence which was contained in individual opaque envelopes for used by the chief investigator As the patients were recruited the next envelope in the sequence was opened and the student was assigned to the stated group All randomisation sequence generation and preparation of group allocation materials was performed by a third party who had no direct contact with the clinical aspects of the trial
The sample size was calculated as 160 each arm to detect 5 caries change with 80 power All children in both groups were provided with a self-administered pre tested questionnaire to assess the quality of life associated with presence of dental caries Further all the children received routine caries preventive measures of oral hygiene instructions dietary advice and professional cleaning Clinical examinations of all children were performed at the beginning of the study and 1 year and 2 years later All the caries at the dentinal level of both groups were stabilized with temporary restorations at the beginning Both varnish and control groups were subjected to use of fluoride tooth paste of 1000ppm Children in the intervention group received fluoride varnish professionally applied after prophylaxis every 6 months combined with counselling on maintenance of oral hygiene and diet for a period of 2 years The control group was only subjected to counselling on maintenance of oral hygiene and diet
During the period of two years a team visited each school four times at six months interval for recruitment dental examinations and fluoride varnish applications Trained interviewers collected data on oral health habits and sociodemographic characteristics of the children Caries examinations were conducted using the International Caries Detection and Assessment System ICDAS
The primary outcome studied was the number of new caries in the two study groups Students and the interviewers were blinded to the intervention varnish application or control and they were blinded to the hypothesis which was investigated in this study
Analysis
The mean number of caries between different groups segregated according to the variables assessed in the study were compared The mean number of caries in a particular group was calculated by dividing the total number of caries in a particular group by the total number of students in that group As the number of caries showed a skewed distribution Mann-Whitney U test was used compare the groups Level of significance was considered as p005
The effect of intervention was measured by the mean number of new caries in different groups The number of new caries in the usual care and intervention group was calculated at each time point of the survey The mean number of new caries between the two groups were compared using Mann-Whitney U test To assess the independent effect of the intervention on the incidence of caries when other factors are controlled multiple linear regression was applied
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