The Effect of Enzyme-containing Mouth Spray on Oral Health Status and S.Mutans Levels in Paediatric Patients Attending Hospital Universiti Sains Malaysia ( HUSM ) , Kelantan
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Plaque Score
研究概览
简要总结
An interventional study was done on evaluating the Effect of Enzyme-containing Mouth Spray on Oral Health Status and S.Mutans levels in Paediatric Patients attending Hospital Universiti Sains Malaysia ( HUSM ) , Kelantan. This study compared the gingivitis score , plaque score and saliva bacteria count between the patients receiving a standard preventive advice alongside with normal saline mouth spray and those receiving standard preventive advice alongside with an enzyme containing mouth spray .
详细描述
General Objective
To evaluate the effect of enzyme-containing mouth sprays on children's oral health compared to those receiving normal saline mouth spray with standard preventive advice after a 4-week follow-up.
Specific Objectives
- To compare the mean plaque score in children using enzyme-containing mouth sprays with standard preventive advice compared to children receiving normal saline mouth spray with standard preventive advice after a 4-week follow-up.
- To compare the mean gingivitis score in children using enzyme-containing mouth sprays with standard preventive advice compared to children receiving normal saline mouth spray with standard preventive advice after a 4-week follow-up.
- To compare the mean saliva bacterial count in children using enzyme-containing mouth sprays with standard preventive advice compared to children receiving receiving normal saline mouth spray with standard preventive advice after a 4-week follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 4 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children of age group 4-7
排除标准
- •Children with medical problems
- •Children with Special Needs
- •Uncooperative Children ( Level of Cooperation would be measured using Frankl's behavior scale)
- •Reviewer's comment : To list down Frankl's Classification and how we define uncooperative
- •As per AAPD 2022 , The Frankl behavior rating scale is a frequently used behavior rating systems in both clinical dentistry and research. This scale indicates observed child's behaviors into four categories (1; Definitely negative, 2; Negative, 3; Positive, 4; Definitely positive)
- •_ _ Definitely negative. Refusal of treatment, forceful crying, fearfulness, or any other overt evidence of extreme negativism.
- •_ Negative. Reluctance to accept treatment, uncooperative, some evidence of negative attitude but not pronounced (sullen, withdrawn).
- •+ Positive. Acceptance of treatmen, cautious behavior at times, willingness to comply with the dentist, at times with reservation, but patient follows the dentist's directions cooperatively.
- •++ Definitely positive. Good rapport with the dentist, interest in the dental procedures, laughter and enjoyment
结局指标
主要结局
Plaque Score
时间窗: 4 weeks
Was measured using the Silness-Loe Plaque Index 1964 from each patient before and after the intervention in both control and case study groups and the mean score and standard deviation was recorded in a table. Scoring Criteria 0 No plaque 1. A film of plaque adhering to the free gingival margin and adjacent area of the tooth. 2. Moderate accumulation of deposits within the gingival pocket, on the gingival margin and/ or adjacent tooth surface. 3. Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin. PIaque Score formula: Total scores / No of teeth examined Range of scores : Excellent : 0 Good : 0.1-0.9 Fair: 1.0-1.9 Poor: 2.0-3.0
次要结局
- Gingivitis Score(4 weeks)
研究者
Ashwini M. Madawana
Principal Investigator
Hospital Universiti Sains Malaysia