Oral hygiene in School Children
- Conditions
- Periodontal disease, unspecified, (2) ICD-10 Condition: K053||Chronic periodontitis,
- Registration Number
- CTRI/2021/02/031544
- Lead Sponsor
- National Institute of Unani Medicine Bangalore
- Brief Summary
Oral health is a key indicator of overall health, well-being and quality of life. It encompasses a range of diseases and conditions that include dental caries, Periodontal disease, Tooth loss, Oral cancer, Oral manifestations of HIV infection, Oro-dental trauma, Noma and congenital disabilities cleft lip and palate. The Global Burden of Disease Study 2017 estimated that oral diseases affect 3.5 billion people worldwide, with untreated dental caries being among the most prevalent non-communicable diseases. Inflammatory periodontal diseases such as gingivitis and periodontitis are among the major public health-related problems in the current world. The world health organisation (WHO) says 60% to 90% of school children are affected by dental caries, leading to plaque. In the United States, prevalence among 6-11 and 12 –19 age groups were 50.5% and 53.8% respectively in 2016, in India it was 53.8% and 63.1% for the age groups of 5 – 12 and 12 -15 respectively.
Mechanical removal of plaque by using a toothbrush and dental floss has been considered an effective method in controlling gingivitis. Usage of dentifrices and mouthwashes containing chemical or herbal agents are suggested as an additional approach. Chlorhexidine (CHX) use as antiseptics in mouthwashes. There have been hypersensitivity reports, stain formation on the teeth surface, oral mucosa irritation, and altered taste with Chlorhexidine. Unani physicians recommend a large number of single drugs and compound formulations in the form of Mazmaza (mouth wash), Sanoon (tooth powder), Mazoogh (chewed) etc. for the prevention and treatment of oral diseases. This study is designed to assess the role of Aqarqarha (*Anacyclus pyrenthrum* dc), Mazoo (*Quercus infectoria* Oliv), Beekh Kibr (*Capparis spinose*root) and Poste Anar (*Punica granutum* peel) in maintaining oral health.
The Objectives of the Study are to evaluate the efficacy and safety of Prepared Herbal Mouthwash in maintaining oral health: and to compare the effect of Prepared Herbal Mouthwash and 0.2% Chlorhexidine Mouthwash in maintaining oral health. The study will be conducted among school children age 8 to 15 years. Data will be collected from Complete medical and dental history, Oral examination, Standard questionnaire, and Dental Indices and Scorings. Measurement Plaque index (PI & PIS), Measurement Gingival index (GI & BOP), Measurement DMFT, Oral hygiene index-simplified (OHIS) and Salivary pH will be used as Parameters for the efficacy assessment of the drug. Students who are fulfilling inclusion criteria will be given consent form having details about the nature of the study. If parents and student agree to participate in the study, then he/she will be asked to sign the consent form. The duration of the study will be1 year, and duration of protocol therapy will be120 days. The study is a Single-blind randomised standard controlled trial, and the sample size would be 110. The participants will be randomly divided into two equal groups call test and Control group. The test group will be given prepared herbal mouth wash for rinsing, and the control group will be given Chlorhexidine (0.2%) for rinsing.
The outcome will be assessed by oral examination and PI, GI, DMFT and Oral, OHIS Indices and salivary pH. The result will be evaluated statistically, using appropriate tests
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 110
- Age 08 to 15 years Both male and female.
- Free from systemic diseases.
- Gingival scores(GI) moderate(≥2.0 (Silness & Loe)) or ≥ 25% of Bleeding on Probing- BOP(Ainamo & Bay 1975) and Plaque scores(PI) fair(≥2.0 ( Loe & Silness)) or ≥ 25% of plaque index simplified(PIS) (O’Leary et al,1972) DMFT (Decayed, Missing, and Filled Teeth) scores 3 to 6.
- A minimum of 12 gradable teeth.
- Should not have used mouthwashes for the last 1 month.
- Normal occlusion, absence of caries and/or restorations, a healthy periodontium.
- Poor Oral Hygiene (Assessed by oral hygiene index-simplified (OHIS), 1964 with mean OHIS scores of 1.3 – 3.0 Student who got informed consent from Parents.
- With diseases which might affect the salivary flow.
- History of antibiotic therapy (Last 6 months) Currently using any mouthwashes or has used in the past 1 month.
- Less than 12 teeth available for evaluation.
- History of Immunosuppressive diseases.
- Addicted to tobacco use, smoking, drug or alcohol.
- Undergone periodontal treatment in the previous 6 months.
- Students age < 08 and > 15 years Whose parents are not willing to give informed consent.
- Participants who don’t like to participate.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Reduce Plaque 2 Months 2.Reduce Gingivitis 2 Months 3Maintain or Restore Favourable Salivary pH 2 Months
- Secondary Outcome Measures
Name Time Method 1.Improvement of Oral hygiene 2.Maintain Good DMFT Score(Decayed,Missed, Filled,teeth)
Trial Locations
- Locations (1)
NOBEL ENGLISH HIGH SCHOOL
🇮🇳Bangalore, KARNATAKA, India
NOBEL ENGLISH HIGH SCHOOL🇮🇳Bangalore, KARNATAKA, IndiaMGAMFM FAHIMPrincipal investigator7022908955fahimfuard@yahoo.com