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临床试验/CTRI/2024/03/063651
CTRI/2024/03/063651尚未招募不适用

A Prod into the Efficacy of Visual Medium in Enhancing Oral Health Behaviour among Aural & Verbally Challenged Children via a RCT, in Bhubaneswar city, Odisha

N Sweta Abhaya Laxmi1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年3月14日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
70
试验地点
1
主要终点
1.To encompass proper knowledge regarding oral health maintenance among the hearing and speech impaired children.

研究概览

简要总结

A P****rod into the E****fficacy of V****isual M****edium in E****nhancing Oral Health Behaviour among A****ural & V****erbally C****hallenged C****hildren via a RCT, in Bhubaneswar city, Odisha

**Need for the Study :**Dental care is the most unmet health care need of the disabled children. It is observed that these children relatively have poorer oral hygiene and increased prevalence of gingival diseases and dental caries due to lack of proper brushing techniques and habits.

Aim/s of the Study:

A Prod into the efficacy of  visual mediums  in Enhancing Oral Health Behaviour in Aural and Verbally  Challenged Institutionalised Children of 6-12 years old in Bhubaneswar City, Odisha.

|Objective/s of the Study:

1. To encompass proper knowledge regarding oral health maintenance among the hearing and speech  impaired children.

2. To educate the children regarding proper brushing technique using  different visual aids (picture book , video & sign language)

3. To compare the oral hygiene among hearing and speech impaired children of 6-12 years old in two groups .

Materials & Methods

A double blinded, randomized clinical trial will be carried out on 70 hearing and speech impaired school children of 6–12 years in Bhubaneswar City, Odisha. Permission will be obtained from the  institution for hearing and speech impaired children. The study procedure will consist of a baseline data, interventions, one reinforcement for allocated groups, and followup examinations after 3 months. Children will be selected by the probability simple random sampling method and will be divided into three groups.

Study design and its purpose will be explained to the school authorities, and former consent will be procured by the parents/guardians of the children from the school for deaf and mute. An interactive session will be conducted at the beginning of the study, in order to create a good rapport and understanding with the children. Documentation will be done using a selfdesigned format that will include personal details such as name, age, gender and questionnaire which will be given to the institutionalized students to fill out.

Before the start of the study, baseline data of Plaque index and Oral Hygiene Index-Simplified will be recorded for Groups I and II . Two individuals who will be trained and calibrated before beginning the study to eliminate inter examiner and intra examiner bias, will perform the interview and clinical oral examination.

Individually, each participant will be explained about maintenance of good oral hygiene, curbing sweets intake to not more than three times/day,  the role of fluoride in prevention of dental caries, Fone’s brushing technique, and to brush their teeth twice daily through booklet, sign language video and manualism.  Caretakers will be advised and instructed to make a check on all the participants of their daily brushing frequency. The brushing technique and proper maintenance of oral hygiene will be explained to the teachers so that they could include a session in their daily classes (until the time of the intervention).

Group I (Picture book) will be given a book on oral health which will include the simple pictures and facts about teeth and their functions, the foods which are good and bad for oral health,balanced diet,Fone’s brushing technique,oral hygiene routine,some exercises and a self maintaining planner of their frequency of brushing. The book will be printed in Odia language for the convenience of the students.

For Group II( video group), the contents which are present in the book will be explained with the help of sign language by a trained individual who is trained in sign language.

Oral hygiene will be assessed using Plaque index and Oral Hygiene Index-Simplified.

|Sample size determination:

Determination of sample size is done by G Power Software.

**11.1 Sample Size:**70

|11.2 Source of Data :

BBC GOVT VOCATIONAL HSS FOR THE HEARING IMPAIRED. Unit -3, BBSR -22

|11.3 Inclusion & Exclusion Criteria:

Inclusion-

hearing and speech impaired children

Patient acceptance/cooperation for oral examination

Parental compliance.

Exclusion-

Concomitant medical conditions

Patient cooperation not attained

Parental consent not obtained

|6.4 Method of Collection of  Data (Including sampling Procedure, if any):

Baseline data will be taken which will include selfdesigned format that will include personal details such as name, age, gender which will be provided to the students to fill out , assessing their daily oral hygiene practice. Followed by the intervention for the two groups.

After 15 days follow up will be done and then after 2months final analysis of the data will be done.

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, Investigator and Outcome Assessor Blinded

入排标准

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

入选标准

  • hearing and speech impaired children Patient acceptance/cooperation for oral examination Parental compliance.

排除标准

  • Concomitant medical conditions Patient cooperation not attained Parental consent not obtained.

结局指标

主要结局

1.To encompass proper knowledge regarding oral health maintenance among the hearing and speech impaired children.

时间窗: Baseline data will be taken which will include selfdesigned format that will include personal details such as name, age, gender which will be provided to the students to fill out , assessing their daily oral hygiene practice. Followed by the intervention for the two groups. | Periodic reinforcement of oral health education will be given at 1 week,4 week and 8 week interval.

2.To educate the children regarding proper brushing technique using different visual aids (picture book , video)

时间窗: Baseline data will be taken which will include selfdesigned format that will include personal details such as name, age, gender which will be provided to the students to fill out , assessing their daily oral hygiene practice. Followed by the intervention for the two groups. | Periodic reinforcement of oral health education will be given at 1 week,4 week and 8 week interval.

3.To compare the oral hygiene among hearing and speech impaired children of 6-12 years old in two groups .

时间窗: Baseline data will be taken which will include selfdesigned format that will include personal details such as name, age, gender which will be provided to the students to fill out , assessing their daily oral hygiene practice. Followed by the intervention for the two groups. | Periodic reinforcement of oral health education will be given at 1 week,4 week and 8 week interval.

次要结局

  • To help every school child appreciate the importance of a healthy mouth and relationship of dental health to general health and appearance.(To encourage the observance of dental health practices, including personal care, professional care, proper diet, and oral habits.)

研究者

发起方
N Sweta Abhaya Laxmi
申办方类型
Other [self sponsored]
责任方
Principal Investigator
主要研究者

N Sweta Abhaya Laxmi

Kalinga Institute of Dental Sciences

研究点 (1)

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