Effectiveness of Indigenous customized toothbrush versus commercially available toothbrushes in improving oral hygiene among Intellectually disabled children – a Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Effectiveness of indigenous customized toothbrush with commercially available toothbrushes among intellectually disabled children
研究概览
简要总结
**AIM:**To compare the effectiveness of indigenous customized toothbrush with commercially available toothbrushes among intellectually disabled children.
RESEARCH QUESTION: Is there a difference in the effectiveness of indigenous customized toothbrush in comparison with commercially available toothbrushes among intellectually disabled children?
STUDY POPULATION: Intellectually disabled children inPuducherry and Cuddalore
SAMPLING PROCEDURE: The sampling method by which the study subjects would be selected is Cluster Sampling.
STUDY GROUPS:
Group A – (n=22) – Indigenous customized manual toothbrush (adult/junior)
Group B – (n=22) – Sonic Powered Toothbrush (adult/junior)
Group C – (n=22) – Manual Toothbrush (adult/junior)
**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 cerebral palsy from a previous study. With 80% power and alpha error 5%, the minimum sample size was calculated to be 60, n=20 in each group. Anticipating a 10% loss to follow up, the sample size is calculated as 22 per group (n=22). Thus, the total sample size N=66
METHODOLOGY:
Before the experiment, each participant will undergo professional prophylaxis to ensure plaque-free status. At baseline, oral examination will be performed. **Oral Examination:**The plaque scores will be assessed using Turesky modification of the Quigley – Hein Plaque Index, 1970. Subjects will be asked to brush their teeth after examination to wash off the disclosing agent.The gingival scores will be assessed using Loe & Silness Gingival Index, 1963
Interventions for Group A, B, C:
Trial Phase: Assisted toothbrushing (0-14 days):
The study subjects will be advised to refrain from other oral hygiene practices except their allocated intervention during the study period. Respective toothbrushes and toothpastes will be provided to the caregivers/parents and proper toothbrushing technique (modified Bass technique) will be taught to both caregivers/parents/guardian and children through videos and typodont models. The children will be performing parent/caregiver-assisted toothbrushing 2 times daily for 14 days. The interventional compliance will be assessed by providing checklist pamphlets to caregivers/parents where they will record the date and time of the intervention for 3 months.
**15th -day visit:**Subjects will be clinically evaluated with respect to Plaque and Gingival scores. Oral hygiene instructions will be reinforced.
Supervised toothbrushing (15 days -3 months):
**1- month visit:**Subjects will be clinically evaluated with respect to Plaque and Gingival scores. Oral hygiene instructions will be reinforced.
**3- month visit:**Subjects will be clinically evaluated with respect to Plaque and Gingival scores.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Investigator Blinded
入排标准
- 年龄范围
- 6.00 Year(s) 至 18.00 Year(s)（—）
- 性别
- All
入选标准
- •Study subjects aged 6 to 18 years in the mixed and permanent dentition Study subjects having ID categorized as limit IQ as mild or moderate Study subjects being part of psychosocial support groups under the supervision of a trained monitor Study subjects with plaque induced gingivitis.
排除标准
- •Subjects suffering from chronic debilitating conditions like Epilepsy Down syndrome etc and on long term medications which could influence their oral status Subjects with history of receiving antibiotic and antiseptic therapy Subjects with physical disabilities impaired motor functions non compliant behaviour etc Subjects who are not willing to participate and did not give informed consent and assent Patients with true periodontal pockets Subjects undergoing fixed orthodontic therapy.
结局指标
主要结局
Effectiveness of indigenous customized toothbrush with commercially available toothbrushes among intellectually disabled children
时间窗: 3 months
次要结局
- Effectiveness of indigenous customized toothbrush on TMQHPI scores and GI scores among intellectually disabled children(14 days, 1 month & 3 months)
- Effectiveness of sonic powered toothbrush on TMQHPI scores and GI scores among intellectually disabled children(14 days, 1 month & 3 months)
- Effectiveness of manual toothbrush on TMQHPI scores and GI scores among intellectually disabled children(14 days, 1 month & 3 months)
研究者
Dr Roshni Maria Irwina A
Indira Gandhi Institute of Dental Sciences