| 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 |
|
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Regulatory Clearance Status from DCGI
|
|
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)
|
|
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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.
|
|
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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
|
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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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