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CTRI Number  CTRI/2025/04/084789 [Registered on: 15/04/2025] Trial Registered Prospectively
Last Modified On: 11/04/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Preventive
Screening
Dentistry
Behavioral 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effectiveness of Animated Voice-Assisted Guidance and Enhancement Technique (AVAGE) on oral health among children in need of care and protection 
Scientific Title of Study   Effectiveness of the novel Animated Voice Assisted Guidance and Enhancement Technique(AVAGE) on oral hygiene, dentition status and treatment needs among 12 to 18 years old juvenile detainees in Goa: A double blind randomized controlled study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Fakheem Saqalain Labib 
Designation  Undergraduate Student 
Affiliation  Goa Dental College & Hospital 
Address  Department of Public Health Dentistry, Goa Dental College & Hospital, Bambolim, Goa

North Goa
GOA
403202
India 
Phone  9568058575  
Fax    
Email  fakheem.labib@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Atrey Jagdish Pai Khot  
Designation  Lecturer 
Affiliation  Goa Dental College and Hospital 
Address  Department of Public Health Dentistry, Goa Dental College & Hospital, Bambolim, Goa

North Goa
GOA
403202
India 
Phone  9049735410  
Fax    
Email  atreypaikhot01@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Ridhima Gaonkar 
Designation  Professor 
Affiliation  Goa Dental College and Hospital 
Address  Department of Public Health Dentistry, Goa Dental College & Hospital, Bambolim, Goa

North Goa
GOA
403202
India 
Phone  9326469134  
Fax    
Email  drbirmani@gmail.com  
 
Source of Monetary or Material Support  
Department of Public Health Dentistry, Goa Dental College & Hospital, Bambolim, Goa-403202 
 
Primary Sponsor  
Name  Indian Association of Public Health Dentistry (Ref. No. IAPHD/O.C.No.154/2024) 
Address  32-401, Milroc Kadamba, Old Goa, Goa-403402 
Type of Sponsor  Other [Public Health Dentistry Association] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Atrey J Pai Khot  Apna Ghar Juvenile Detention Centre  Room no:2, Apna Ghar, Merces, Tiswadi, Goa 403006
North Goa
GOA 
9049735410

atreypaikhot01@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Goa Dental College and Hospital Institutional Ethics Committee  Approved 
Permission from Apna Ghar Juvenile Detention Centre   No Objection Certificate 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Z609||Problem related to social environment, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Control Group  Oral health education will be delivered using conventional health talk and brushing demonstration using a model. 
Intervention  Experimental Group: Animated Voice-Assisted Guidance and Enhancement Technique  A customized animated video of approximately 7.8 minutes will be played on the screen for the experimental group. The content will display an introduction to oral health and its significance in general health, the appropriate brushing technique, and five golden rules for maintaining effective oral health. 
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  1.Detainees aged 12 to 18 years will be included in the study.
2.Detainees willing to give informed consent will be included in the study.
 
 
ExclusionCriteria 
Details  1.Detainees suffering from multiple systemic diseases.
2.Detainees suffering from acute infections in the past one month.
3.Uncooperative detainees.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Improve oral health status of children which will be evident clinically with reduced dental caries, gingival and plaque scores.  Baseline, 1 month and 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement of oral hygiene practices and behaviour by simplified understanding through AVAGE.  Baseline, 1 month and 3 months 
 
Target Sample Size   Total Sample Size="36"
Sample Size from India="36" 
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 2/ Phase 3 
Date of First Enrollment (India)   05/06/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Objectives:

1.    To assess oral health status of juvenile detainees at baseline by using plaque index and gingival index.

2.    To assess dentition status and treatment needs among juvenile detainees.

3.   To assess oral hygiene practices using a validated questionnaire at baseline.

4.  To compare and evaluate oral hygiene status and practices at three months interval using plaque index and gingival index.


Research Hypothesis:

There is a difference in oral hygiene status and practices among juvenile detainees at one month and three months interval after giving oral health intervention using AVAGE and conventional methods by evaluation using plaque and gingival index.


Background of the study:

-  Juvenile delinquency (or juvenile offending) is participation of minors

less than 18 years of age in illegal behaviour. A juvenile alleged to have breached the law is called a “delinquent juvenile.” The juvenile criminal offence is increasing day-by-day and is one of the major issues faced by the present world. These are also a truly neglected group as there is no proper care for their health and well-being.

-  As per the statistics available, there are 10.2 juvenile offenders per 1 lack population in the world. In India the percentage of recorded juvenile crimes are about 0.9 to 1 % of total crimes.

-  Juvenile inmates often enter the correctional facilities with pre-existing oral health issues. Many come from backgrounds marked by poverty and limited access to comprehensive healthcare, including dental care. Consequently, they are at risk of developing oral diseases due to inadequate oral hygiene practices and dietary habits. These socio- economic factors contribute to higher rates of untreated dental condition which can exacerbate their already challenging circumstances.

 A visual memory is rapidly acquired and long standing compared to conventional methods. Animations can be incorporated as teaching tool to create visual awareness, improve attention span, and aid with memory strategies and reasoning in a fun and innovative manner. Therefore, AVAGE was developed to enhance oral health education practices with new technological capabilities, overcome language barriers and make learning interesting.


Existing deficiencies of current literature:

 Caries prevalence in permanent dentition of Juvenile Prisoners and Abandoned Children in Government Organizations in Ahmedabad within age 11-17 years, the prevalence was 34.21%. The Juvenile group had a fair to poor OHI (3.47 ±1.17) in 11-17 years age.

 It was found that Overall periodontal disease prevalence was 80.2% with bleeding and calculus contributing a major part (71.9%) among 

      the juvenile detainees in Udaipur.

- Significant research in this niche is lacking till date, that recommends

    clear guidelines for determining ideal intervention for these individuals.


Rationale:

- It has been found that conventional methods on its own does not give satisfactory results in changing oral health behaviour and attitude among juvenile detainees.

- The need for focusing on oral health interventions in juvenile detainees is tied to bigger goals of rehabilitation and reintegration of the such individuals in the society. Therefore, facilitating access to better oral health and hygiene through interventions can positively impact the rehabilitation process.

- By addressing oral health of juvenile inmates proactively, we are not only improving immediate quality of life but also supporting long- term outcomes for these young individuals.

- This fundamental oral health education tool will allow the individual to comprehend, absorb and adopt better oral hygiene practices and into their routine life.

- Hence, the aim of the study is to evaluate a difference in oral hygiene status and practices among juvenile detainees at one month and three months interval after giving oral health intervention using ‘Animated Voice-Assisted Guidance and Enhancement Technique’ (AVAGE) and conventional methods.


Study design:

Randomized controlled clinical study with concurrent parallel design with

  double blinding.


Study setting:

  The population comprises of children within Juvenile Detention Center in

  Goa: Apna Ghar Juvenile Detention Centre, Merces-Goa

  Study population: Juvenile detainees aged 12-18 years


Study duration: 3 months


Sample size: 

 Sample size calculation was done based on erstwhile data procured from a

 former study “Gaur et al, 2023”. Following formula was used with type I

 error of 5%, power as 80% and dropout considered to be 10%.

(Z1-α/2+ Z1-β)2(𝑆𝐷12 + 𝑆𝐷22)

n =

(𝑥 1- 𝑥 2)2

Where,

SD1= 0.36, SD2= 0.26

X1= 1.88, X2= 2.17

Z₁-α/â‚‚ = α-error at 5% = 1.96, Z₁-ᵦ = power of test at 80% = 0.842 Sample Size   = 18 (Each group)

Total Sample Size = 36


Sampling technique:

§ A simple random sampling technique. (Lottery Method)

Allocation concealment using SNOSE (sequentially numbered, opaque, sealed envelope) technique


Procedure for measurements including process for standardization:

 Procedure for measurements including the process of standardization, standard protocol will be adapted to record indices. The indices will be recorded in the morning 10 AM to 1 PM after breakfast and before lunch with no snack time in between.

 Oral hygiene instructions will be given to standardize oral measurement at baseline. Subjects will be asked not to refrain from oral hygiene procedures.

 -  The control group will also receive a similar type of OHE (AVAGE

Technique) after completion of phase 3.


Details of data to be collected:

 Assessment of knowledge, attitude and practices at baseline 1 month and 3 months

Evaluation of KAP regarding oral health will be assessed using validated questionnaire at baseline and 3 months.

 Clinical Examination:

The standard protocol will be adapted to record WHO oral assessment form 1997, plaque index (Silness J. and Loe H. 1964), gingival index (Loe H. and Silness J. 1963).


Statistical details:

 Descriptive statistics will be applied to calculate the prevalence of oral disease.

 Mann-Whitney U test/Unpaired T test will be applied to assess difference between 2 groups, with level of significance p < 0.05.

 McNemar test will be used to assess the changes in response before

    and after intervention.

 
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