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Consumption of Pomegranate fruit seed in diet for prevention of early childhood caries in childre

Phase 2
Completed
Conditions
Health Condition 1: K00-K95- Diseases of the digestive system
Registration Number
CTRI/2020/09/027715
Lead Sponsor
KVG Dental college Hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
500
Inclusion Criteria

1) Children who will be diagnosed as having early childhood caries

2) Children who have consumed pomegranate 60% times of the total time frame only will

be considered in study group

3) Children who will consume pomegranate in a measuring cup as provided by the

investigator

4) Children who maintains record of the timings of consumption of pomegranate during the

day

5) Children who fall in the age group of three to eight years

6) Children who are living in non fluoridated area

7) Parents who have obtained consent for the study

Exclusion Criteria

1) If children who consumed pomegranate twice a week in a control group will not be

considered

2) Children who have obtained preventive treatment recently will not be considered

3) Children who have any systemic disease will not be considered

4) Children who has taken any medication or special drug use

5) Children who have undergone any oral prophylaxis within one year

6) Children who are allergic to any components of pomegranate

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Early child hood decay in Children who maintains timings of consumption of pomogrante more than 60% of the total time frame will be assessed (evaluated using diet book for child) for salivary ph and buffering capacity using ph strips and plaque adherence using plaque index, caries risk assessment done using ICDAS-II criteria. Data will be collected after 3minute and 1 hour after consumption of pomegranate at baseline and after 3, 6 and 12 months.Timepoint: Early child hood decay Children who maintains timings of consumption of pomogrante more than 60% of the total time frame will be assessed for salivary ph and buffering capacity using ph strips and plaque adherence using plaque index, caries risk assessment done using ICDAS-II criteria. Data will be collected after 3minute and 1 hour after consumption of pomegranate at baseline and after 3, 6 and 12 months.
Secondary Outcome Measures
NameTimeMethod
Early child hood decay in children will be recorded using ICDAS 2 criteria at baseline after 12 months. <br/ ><br>Diet book of each child also will be evaluated after 12 monthsTimepoint: 12 months
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