To evaluate and compare aquaporin 5 (AQP-5) salivary flow rate and caries experience in children with type 1 diabetes mellitus and non diabetic children before and after topical remineralizing therapy
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Quantification of Aquaporin-5 and Salivary Flow Rate in Non-Diabetic children Without Dental Caries.
研究概览
简要总结
METHOD OF STUDY:
SAMPLE COLLECTION: A total of 45 children who meets the inclusion criteria are selected for the study and grouped as follows;
Control group (n=15): Non-Diabetic children with no dental caries.
Experimental Group 1 (n=15): Non-Diabetic children with Dental caries greater than or equal to 3, ICDAS II criteria ,CODE 03 &04.
Experimental Group 2 (n=15): Type 1 Diabetes Mellitus children with Dental caries greater than or equal to 3, ICDAS II criteria ,CODE 03 &04.
All subjects will be instructed to refrain from eating and drinking for 1 hr before the saliva sample collection. Pre-intervention unstimulated saliva sample will be collected by spitting method. The patients will be asked to rinse the mouth with filter water twice before the collection. After the oral rinse, Children will be asked to spit the saliva into sterile tubes for a period of 5 mins. Then, these tubes will be sealed immediately after sample collection and stored in laboratory at 4 degree celsius in refrigerator. DMFT/dmfs index is recorded in children from Experimental Group 1 and Experimental Group 2. Identified carious teeth will be isolated and Nano silver fluoride will be applied directly to lesions with micro brush and left for 2minutes. Post application instructions will be given and children are instructed to use fluoridated mouthwash(once daily) and fluoridated toothpaste(twice daily) at home for a period of one month. This is mainly to have regular exposure to fluoride as Aquaporin-5 is known to uptake fluoride and its levels are known to get affected by continuous fluoride exposure. The children will be recalled after one month from the day of application. Post-intervention saliva samples will be collected from Experimental Group 1 and Experimental Group 2 through same procedures as mentioned above. All the samples will be subjected to ELISA.
Estimation of Flow Rate
Procedure:
Ensure the children refrain from eating, drinking, or brushing their teeth for at least 1 hour before the test.
Children will be seated, relaxed, and avoid talking during the collection.
Children will be asked to slightly bent their head forward and let saliva pool in their mouth. Unstimulated saliva will be collected in the sterile vial.
Flow rate will be determined in millilitres/minute (mL/min).
The results obtained will be subjected to statistical analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 7.00 Year(s) 至 12.00 Year(s)(—)
- 性别
- All
入选标准
- •Children with 7 to 12 years of age.
- •Non Diabetic children without dental caries.
- •Non-Diabetic Children with ICDAS II criteria CODE 03 and
- •Children with Type1 Diabetes Mellitus having ICDAS II criteria, CODE 03 and
- •Parents giving consent for the study.
排除标准
- •Children who received fluoride topical application during the last 1 month.
- •Children requiring special health care needs.
- •Pulpally involved and grossly decayed teeth.
结局指标
主要结局
Quantification of Aquaporin-5 and Salivary Flow Rate in Non-Diabetic children Without Dental Caries.
时间窗: Baseline - 1 month
Quantification of Aquaporin-5 and Salivary Flow Rate in Non-Diabetic children having dental caries, before and after the application of topical remineralizing therapy.
时间窗: Baseline - 1 month
次要结局
- Quantification of Aquaporin-5, Salivary Flow Rate and dental caries experience in children with Type 1 Diabetes Mellitus before and after the application of topical remineralizing therapy.
研究者
DR ABHIRAMI K
Rajarajeswari Dental College and Hospital
