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临床试验/CTRI/2025/03/081607
CTRI/2025/03/081607尚未招募2 期

Effectiveness of various education methods on oral health knowledge plaque and gingival health among hearing and speech-impaired children - A randomized controlled trial

Dr Jane Roshini R1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2025年3月17日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
54
试验地点
1
主要终点
effectiveness of DIY kit intervention of oral hygiene education with

研究概览

简要总结

AIM: To compare the effectiveness of DIY kit intervention of oral hygiene education with visual and caregiver guided education methods among hearing and speech impaired children.

STUDY POPULATION : Hearing and Speech impaired children

RESEARCH QUESTION: Is there any difference in the effectiveness of DIY kit intervention in comparison with visual and caregiver-guided oral health education methods on oral health knowledge, plaque and gingival health among hearing and speech-impaired children?

SAMPLING PROCEDURE: The study subjects will be randomly allocated into three study groups using cluster randomization.

STUDY GROUPS:

The number of groups is 3.

• Group A – (n=18) – DIY kit intervention on oral health education

• Group B – (n=18) – Visual guided education method

• Group C – (n=18) – Caregiver guided education method

SAMPLE SIZE :

The sample size was calculated using G power software version 3.1. The calculation was based on the mean Plaque scores among children with hearing and speech impaired from a previous study conducted by Maria Moin et al (2021) (). With 95% power and alpha error 5%, the minimum sample size was calculated to be 48, n=16 in each group. (ANNEXURE 1). Anticipating a 10% loss to follow up, the sample size is calculated as 18 per group (n=18). Thus, the total sample size N=54

METHODOLOGY :

The study subjects will be selected based on the inclusion criteria and exclusion criteria. The study subjects will be randomly allocated into 3 groups namely Group A, B and C with each group containing 18 participants.

At baseline, Knowledge will be assessed with a newly designed oral health literacy scale which will be assessed for its validity and reliability before beginning the study. The number of correct answers will be summed which gives the score of the newly developed scale. As the score increases, the knowledge increases. Oral Examination: The plaque scores will be assessed using Silness J and Loe H Plaque Index, 1967.  The gingival scores will be assessed using Loe H & Silness J Gingival Index, 1963.

Interventions for Group A:

DIY kit intervention:

• The study subjects will be given DIY kit which contains three activity based oral hygiene education on toothbrushing, diet, and how plaque affects oral health through an experiment.

• The children will be given the instructions of the activity through the sign language.

• The intervention will be given by the primary investigator along with class teacher.

Interventions for Group B:

Visual guided education:

• A visual aid based oral hygiene education will be played.

• The visual aid contains oral hygiene education on brushing technique, diet and about how plaque affects the tooth.

• A video on oral health maintenance will be prepared using sign language with the help of an Indian sign language instructor.

The content of the video will be validated.

Interventions for Group C:

Caregiver guided education:

• The Caregiver will be given oral hygiene education through pamphlet.

• And the caregiver needs to educate the children on oral hygiene education.

All the subjects will be provided with an oral hygiene kit containing a soft bristled toothbrush and fluoridated toothpaste during the study.

Follow up:

Knowledge assessment will be carried out using oral health literacy scale in the three study groups immediately, one week, 15 days and 28 days after intervention. Plaque and gingival index will be assessed on 15th day and 28th day 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
Outcome Assessor Blinded

入排标准

年龄范围
6.00 Year(s) 至 10.00 Year(s)(—)
性别
All

入选标准

  • Study subjects aged 6- 10 years in the mixed dentition. Study subjects having Hearing and Speech Impaired[ Disabling hearing loss refers to hearing loss greater than 35 decibels (dB) in the better hearing ear]. Study subjects being part of psychosocial support groups under the supervision of a trained monitor. Study subjects with plaque-induced gingivitis. Study subjects with plaque index score – 0.1-0.9 and gingival index score.
  • mild gingivitis after the washout period of 14 days.

排除标准

  • Subjects suffering from systemic conditions and chronic debilitating conditions like Epilepsy, Down syndrome, etc., and/or on long term medications which could influence their oral status.
  • Subjects with history of receiving antibiotic and/or antiseptic therapy.
  • Subjects who are not willing to participate and did not give informed consent and assent.
  • Subjects with periodontal disease will be eliminated.
  • Subjects undergoing fixed orthodontic therapy.
  • Subjects with physical disabilities, impaired motor functions, non-compliant behavior, etc.

结局指标

主要结局

effectiveness of DIY kit intervention of oral hygiene education with

时间窗: 28 Days

visual and caregiver guided education methods among hearing and speech impaired

时间窗: 28 Days

children

时间窗: 28 Days

次要结局

  • effectiveness of DIY kit intervention of oral hygiene education using(oral health literacy scale)
  • effectiveness of DIY kit intervention of oral hygiene education using(oral health literacy scale, Plaque and gingival scores)
  • effectiveness of Visual guided oral hygiene education using oral health(literacy scale)
  • effectiveness of Visual guided oral hygiene education using Oral health literacy scale, Plaque and gingival Scores(one week, 15 days and 28 days)
  • effectiveness of Caregiver guided oral hygiene education using oral(health literacy scale)
  • effectiveness of Caregiver guided oral hygiene education using Oral health literacy scale, Plaque and gingival Scores(one week, 15 days and 28 days)

研究者

发起方
Dr Jane Roshini R
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Jane Roshini R

Indira Gandhi Institute of Dental Sciences

研究点 (1)

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