A Clinical Trial to Study the Effects of Two Home Made Mouthwashes in Patients With Gum Diseases

Study Overview
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Brief Summary
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Periodontal Disease is a ubiquitous in nature affecting about 80% population of India. The Periodontal Disease is a multifactorial but the dental plaque is considered as main etiological agent.The dental plaque, a adhesive bacterial coating accumulate around and in between teeth, if not removed by effective daily brushing and flossing, plaque can cause Gum infection and tooth loss. Though, many scientific periodontal procedures are available to get the treatment but because of lack of man power and poor socioeconomic condition it is not possible for every group of population in our India.

Detailed Description
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The need exist for continued research to find the use of home made mouthwashes in preventing periodontal diseases. Although, Chlorhexidine mouthwash is regarded as Gold standard mouthwash as antiplaque but have some limitations like cost factor and side effects like staining of teeth, loss of taste, oral mucosal ulcerations,paresthesia and may enhanced supragingival calculus formation. Use of various indigenous products and home made preparations are easily available and are being used since ancient time in India and still in practice in various parts of India especially rural and remote areas. At the same time the use of potassium permanganate is still in practice in various parts of India and also it was in practice before the availability of Chlorhexidine, povidone iodine and other antiseptic solutions, as they are used since about 30 years only. Use of hot salt water rinsing is in practice especially to reduce the symptoms of various throat infections such as pharyngitis, tonsillitis and also to improve oral hygiene.It is also being used in oral surgery and their effects are also mention in literature. Hence, the aim of this study is to assess and compare the efficacy of home made remedies like hot salt water and potassium permanganate as a mouthwash in reducing Plaque accumulation and improving Gingival conditions with Gold standard Chlorhexidine mouthwash if found effective may be used as affordable mouthwash for the benefit of population of India.

Official Title
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Evaluate the Efficacy of Potassium Permanganate Mouthwash and Hot Salt Water Mouthwash and Their Comparison With Chlorhexidine Mouthwash on Plaque Index,Gingival Index and Periodontal Probing Depth

Conditions
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Gingivitis, Periodontitis

Intervention / Treatment
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* Procedure: HOT SALT WATER
* Procedure: POTASSIUM PERMANGANATE
* Procedure: CHLORHEXIDINE


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject of Chronic Generalized Gingivitis and Mild Generalized Periodontitis. Not undergone any major periodontal treatment earlier in last 06 months . Otherwise Clinically Healthy Patient. Exclusion Criteria: Subjects with significant systemic diseases (e.g. Diabetes Mellitus, Cancer or Coronary heart disease etc.). Pregnant or lactating women. Smoker. Patients on anti-inflammatory drugs or antibiotics Patients allergic to any material used for the study

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HOT SALT WATER<br>3% HOT SALT WATER , 25ml used for rinsing for 60 sec, twice daily for 60 days. | Procedure: HOT SALT WATER<br>* 25ml mouthwash will be rinsed for 60sec), twice daily for 60 days The subjects then will be recalled for measuring the data's after 2weeks, 4weeks, 6weeks and 8weeks.<br>|
| Experimental: POTASSIUM PERMANGANATE<br>0.01% POTASSIUM PERMANGANATE, 10ml used for rinsing for 60 sec, twice daily for 60 days. | Procedure: POTASSIUM PERMANGANATE<br>* 10ml mouthwash will be rinsed for 60sec), twice daily for 60 days The subjects then will be recalled for measuring the data's after 2weeks, 4weeks, 6weeks and 8weeks.<br>|
| Active Comparator: CHLORHEXIDINE<br>0.2% CHLORHEXIDINE, 10ml used for rinsing for 60 sec, twice daily for 60 days. | Procedure: CHLORHEXIDINE<br>* 10ml mouthwash will be rinsed for 60sec), twice daily for 60 days The subjects then will be recalled for measuring the data's after 2weeks, 4weeks, 6weeks and 8weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plaque Index | 4 sites of all tooth is observed | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plaque Index | 4 sites of all tooth is observed | 2weeks | 
| Plaque Index | 4 sites of all tooth is observed | 4weeks | 
| Plaque Index | 4 sites of all tooth is observed | 6weeks | 
| Plaque Index | 4 sites of all tooth is observed | 8weeks | 
| Gingival Index | 4 sites of all tooth is observed | baseline | 
| Gingival Index | 4 sites of all tooth is observed | 2weeks | 
| Gingival Index | 4 sites of all tooth is observed | 4weeks | 
| Gingival Index | 4 sites of all tooth is observed | 6weeks | 
| Gingival Index | 4 sites of all tooth is observed | 8weeks | 
| Periodontal Probing Depth | 6 sites of all tooth is observed | baseline | 
| Periodontal Probing Depth | 6 sites of all tooth is observed | 2weeks | 
| Periodontal Probing Depth | 6 sites of all tooth is observed | 4weeks | 
| Periodontal Probing Depth | 6 sites of all tooth is observed | 6weeks | 
| Periodontal Probing Depth | 6 sites of all tooth is observed | 8weeks |