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CTRI Number  CTRI/2021/02/031544 [Registered on: 25/02/2021] Trial Registered Prospectively
Last Modified On: 08/03/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Unani
Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Oral hygiene in School Children 
Scientific Title of Study   Single blind randomized controlled trial in school children with prepared herbal mouth wash in maintaining oral health in Bangalore 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  MGAMFM Fahim 
Designation  PG Scholar 
Affiliation  National Institute of Unani Medicine, Bangalore 
Address  Department of Tahaffuzi wa Samaji Tib, 2nd Year, National Institute of Unani Medicine, Magadi Main Road, Kottigepalya, Bangalore

Bangalore
KARNATAKA
560091
India 
Phone  7022908955  
Fax    
Email  fahimfuard@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Prof Zarnigar 
Designation  Professor 
Affiliation  National Institute of Unani Medicine, Bangalore 
Address  Department of Tahaffuzi Wa Samaji Tibb, National Institute of Unani Medicine, Magadi Main Road, Kottigepalya, Bangalore

Bangalore
KARNATAKA
560091
India 
Phone  7022669959  
Fax    
Email  zarnigarriaz@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  Prof Zarnigar 
Designation  Professor 
Affiliation  National Institute of Unani Medicine, Bangalore 
Address  Department of Tahaffuzi Wa Samaji Tibb, National Institute of Unani Medicine, Magadi Main Road, Kottigepalya, Bangalore

Bangalore
KARNATAKA
560091
India 
Phone  7022669959  
Fax    
Email  zarnigarriaz@rediffmail.com  
 
Source of Monetary or Material Support  
National Institute of Unani Medicine, Magadi Main Road, Kottigepalya, Bangalore 
 
Primary Sponsor  
Name  National Institute of Unani Medicine Bangalore 
Address  National Institute of Unani Medicine,Magadi Main Road, Kottigepalya, Bangalore -91 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
National Institute of Unani Medicine Bangalore  National Institute of Unani Medicine,Magadi Main Road, Kottigepalya, Bangalore -91 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
MGAMFM FAHIM  NOBEL ENGLISH HIGH SCHOOL  NOBEL ENGLISH HIGH SCHOOL, Main Road, Kottigepalya, Bangalore 560091
Bangalore
KARNATAKA 
7022908955

fahimfuard@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Communication of Decision of the Institutional Ethics Committee(IEC) for Biomedical Research, National Institute of Unani Medicine, Bangalore  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K056||Periodontal disease, unspecified, (2) ICD-10 Condition: K053||Chronic periodontitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Chlorhexidine mouthwash  O.2% Chlorhexidine mouthwash 15ml two times a day for 1 month only(Intervention). followup another 3 month (Total 4 months) 
Intervention  Unani Formulation of Mazmaza  Unani Formulation of Mazmaza including Aqarqarha (Anacyclus pyrenthrum dc) Mazoo (Quercus infectoria Oliv ) Beekh Kibr (Capparis spinosa) Poste Anar (Punica granutum) Sucralose 30% (Sweetening agent) Perseverative Sodium benzoate sodium methyl paraben distilled water and make use by patients for about 1 month only(Intervention). followup another 3 month (Total 4 months)  
 
Inclusion Criteria  
Age From  8.00 Year(s)
Age To  15.00 Year(s)
Gender  Both 
Details  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. 
 
ExclusionCriteria 
Details  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.
Allergy to any ingredient used in the study.
Students age < 08 and > 15 years
Whose parents are not willing to give informed consent.
Participants who don’t like to participate.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1.Reduce Plaque
2.Reduce Gingivitis
3Maintain or Restore Favourable Salivary pH
 
2 Months 
 
Secondary Outcome  
Outcome  TimePoints 
1.Improvement of Oral hygiene
2.Maintain Good DMFT Score(Decayed,Missed, Filled,teeth) 
4 months 
 
Target Sample Size   Total Sample Size="110"
Sample Size from India="110" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   01/03/2021 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
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

 

 

 
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