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CTRI Trial Data PDF of Trial CTRI Website URL - http://ctri.nic.in Clinical Trial Details (PDF Generation Date :- Tue, 28 Sep 2021 19:57:51 GMT) CTRI Number CTRI/2020/07/026431 [Registered on: 08/07/2020] - Trial Registered Prospectively Last Modified On 04/07/2020 Post Graduate Thesis No Type of Trial Interventional Type of Study Diagnostic Screening Dentistry Study Design Randomized, Parallel Group, Active Controlled Trial Public Title of Study A clinical trial to find out the effectiveness of traditional awareness method and anticipatory guidance through motivational interviewing. Scientific Title of Effectiveness of awareness programme in mothers on prevention of early childhood caries during Study covid 19 pandemic in sullia - a randomized control trial Secondary IDs if Any Secondary ID Identifier Details of Principal Details of Principal Investigator Investigator or overall Name Dr Savitha N S Trial Coordinator (multi-center study) Designation Head of Department Affiliation KVG Dental College and Hospital Address Department of Pedodontics & Preventive Dentistry 3rd floor, Room No 6 KVG Dental College & Hospital Kurunjibhag p o Sullia DK Dakshina Kannada KARNATAKA 574327 India Phone 7975047946 Fax Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Dr Savitha N S Query) Designation Head of Department Affiliation KVG Dental College and Hospital Address Department of Pedodntics & Preventive Dentistry 3rd floor, Room No 6 KVG Dental College Kurunjibhag Sullia DK Dakshina Kannada KARNATAKA 574327 India Phone 7975047946 Fax Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name Dr Allwin Antony Designation Senior Lecturer Affiliation KVG Dental College and Hospital Address Department of Pedodontics & preventive Dentistry 3rd Floor, Room no: 6 KVG Dental College& Hospital kurunjibhag p o sullia DK Dakshina Kannada KARNATAKA 574327 India page 1 / 5 PDF of Trial CTRI Website URL - http://ctri.nic.in Phone 7411994160 Fax Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > KVG Dental College & Hospital Kurunjibhag P O Sullia DK Karanataka 574327 Primary Sponsor Primary Sponsor Details Name KVG Dental College Hospital Address Kurunjibhag, Sullia, DK, Karnataka 574327 Type of Sponsor Research institution and hospital Details of Secondary Name Address Sponsor NIL NIL Countries of List of Countries Recruitment India Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email Investigator Dr Savitha KVG Dental College Department of 7975047946 sathyaprasad and Hospital Pedodontics & Preventive Dentistry 3rd drsavithaks123@gmail. floor, Room no 6 KVG com Dental College & Hospital Kurujibhag sullia DK 574327 Dakshina Kannada KARNATAKA Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? Institutional Ethical Approved 10/06/2020 No Committe KVG Dental College and Hospital Regulatory Clearance Status Date Status from DCGI Not Applicable No Date Specified Health Condition / Health Type Condition Problems Studied Healthy Human Volunteers Early childhood caries Intervention / Type Name Details Comparator Agent Intervention ONLINE GROUP The mother & child pairs who fall randomly into online group will be allocated by a stratified randomisation method at the subject level using a personal computer into the following two groups; group 1 (Traditional awareness group) and group 2 (Awareness using with motivational interviewing & anticipatory guidance). There will be no negative control group for ethical consideration. The group 1 will undertake awareness by presentation, videos & posters after consent. The group 2 will then undertake awareness through counselling page 2 / 5 PDF of Trial CTRI Website URL - http://ctri.nic.in sessions (last up to 30 minutes) done within 4 weeks after consent with one additional counselling sessions and the study participant has to face-to-face or phone contact, after first 6 months for review). Evaluation of the implemented awareness session will be done using questionnaires, nyvad index, dmft/def index & caries risk assessment tool. Comparator Agent OFFLINE GROUP The mother & child pairs who fall under offline group will be allocated using a stratified randomisation method at the subject level with a personal computer into the following two groups; group 1 (Traditional awareness group) and group 2 (Awareness using with motivational interviewing & anticipatory guidance). The group 1 will undertake awareness by presentation, videos & posters after consent. The group 2 will then undertake awareness through counselling sessions (last up to 30 minutes) done within 4 weeks after consent with one additional counselling sessions and the study participant has to face-to-face or phone contact, after first 6 months for review. Evaluation of the implemented awareness session will be done using questionnaires, nyvad index, dmft/def index & caries risk assessment tool. Inclusion Criteria Inclusion Criteria Age From 0.00 Month(s) Age To 24.00 Month(s) Gender Both Details 1) Mother accompanied by children less than 2 years old<br/> 2) Mother child pairs who are willing to participate <br/> 3) Mother child pairs who are willing to informed consent. <br/> Exclusion Criteria Exclusion Criteria Details 1) Child having major systemic diseases, such as bleed disorder, cardiac disorder or renal disorder; 2) Children who are on long-term medication such as antiepileptic drugs. 3) Children with oral soft tissue lesion/s, history of allergy to the constituents of fluoride gel, systemic illness and those requiring extensive rehabilitation 4) Mother & child pair who have/had fever or any symptoms of fever 5) Mother & child pair who have/had recent travel history page 3 / 5 PDF of Trial CTRI Website URL - http://ctri.nic.in Method of Generating Computer generated randomization Random Sequence Method of Centralized Concealment Blinding/Masking Participant and Outcome Assessor Blinded Primary Outcome Outcome Timepoints The primary outcome measure will check the Reversal of white spot lesion by awareness effectiveness of awareness by reversal of white Incidence of dental decay Caries risk spot lesions on the anterior teeth examined assessment 24 months using nyvad index and caries risk assessment tool. Incidence of dental decay measured at 6, 12, 18 and 24 months of age using dmft/def index and at 24 months by criteria specified by WHO. Secondary Outcome Outcome Timepoints Secondary outcome measures will record Knowledge, attitude, and awareness of parents changes in knowledge, attitude, and awareness prevalence of dental decay and referral for child of parents towards the oral health of their child dental care 24 months and differences in nutritional and dietary patterns between groups. Long-term outcomes will be the prevalance of dental decay and referral for child dental care among the groups when the child is 4 years of age. Target Sample Size Total Sample Size=700 Sample Size from India=700 Final Enrollment numbers achieved (Total)=Applicable only for Completed/Terminated trials Final Enrollment numbers achieved (India)=Applicable only for Completed/Terminated trials Phase of Trial Phase 1/ Phase 2 Date of First 01/09/2020 Enrollment (India) Date of First No Date Specified Enrollment (Global) Estimated Duration of Years=2 Trial Months=0 Days=0 Recruitment Status of Not Applicable Trial (Global) Recruitment Status of Not Yet Recruiting Trial (India) Publication Details NIL Brief Summary The covid times have made the personal visit to the clinic more of a threat to the mother and child so prevention becomes imperative and early childhood caries a devastating diseases of teeth that can lead to life threatening aftermath if not treated in time. It can be very crippling to neglect it so anticipatory guidance can be very practical in motivating mothers to avoid the known etiologic factors like wrong practice of feeding milk along with other factors. The initial lesion of dental caries which usually begins as a white spot lesion in young child so the mother, the primary care taker will be taught to do the lift the lip technique and show them through video conferencing and lesions will be recorded and after few months the mother will be guided through the reversal of white spot lesion; by the influence of awareness methods and improved oral hygiene aids used which inturn result in shifting the critical ph to neutral and favouring remineralisation which will be evaluated later by the disappearance of white spot lesions. The parent/caregiver, usually the mother, has a critical role in the adoption of protective health care behaviours and parental feeding practices strongly influence children’s status of dental caries. This study finds out if an awareness early oral health promotion intervention through the use of page 4 / 5 PDF of Trial CTRI Website URL - http://ctri.nic.in motivational interviewing (MI) and anticipatory guidance (AG) or traditional awareness method approaches provided to the mother can reduce the incidence of early childhood dental decay in young children. This aim of this study is to create online awareness with the technology of video conferencing & offline awareness with traditional awareness methods in mothers with young babies and sensitise them towards good oral hygiene practices to create awareness at a distance and the sensitisation will be evaluated page 5 / 5 Powered by TCPDF (www.tcpdf.org).
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