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临床试验/CTRI/2025/04/084789
CTRI/2025/04/084789尚未招募2/3 期

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

Indian Association of Public Health Dentistry (Ref. No. IAPHD/O.C.No.154/2024)1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2025年6月5日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
36
试验地点
1
主要终点
Improve oral health status of children which will be evident clinically with reduced dental caries, gingival and plaque scores.

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant and Investigator Blinded

入排标准

年龄范围
12.00 Year(s) 至 18.00 Year(s)(—)
性别
All

入选标准

  • 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.

排除标准

  • 1.Detainees suffering from multiple systemic diseases.
  • 2.Detainees suffering from acute infections in the past one month.
  • 3.Uncooperative detainees.

结局指标

主要结局

Improve oral health status of children which will be evident clinically with reduced dental caries, gingival and plaque scores.

时间窗: Baseline, 1 month and 3 months

次要结局

  • Improvement of oral hygiene practices and behaviour by simplified understanding through AVAGE.(Baseline, 1 month and 3 months)

研究者

发起方
Indian Association of Public Health Dentistry (Ref. No. IAPHD/O.C.No.154/2024)
申办方类型
Other [Public Health Dentistry Association]
责任方
Principal Investigator
主要研究者

Fakheem Saqalain Labib

Goa Dental College & Hospital

研究点 (1)

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