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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02546804
Recruitment Status : Completed
First Posted : September 11, 2015
Last Update Posted : August 6, 2018
Sponsor:
Information provided by (Responsible Party):
Agrima Singh, Government College of Dentistry, Indore

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Gingivitis Periodontitis Procedure: HOT SALT WATER Procedure: POTASSIUM PERMANGANATE Procedure: CHLORHEXIDINE Not Applicable

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : June 2015
Actual Primary Completion Date : October 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Potassium

Arms and Interventions
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Arm Intervention/treatment
Experimental: HOT SALT WATER
3% HOT SALT WATER , 25ml used for rinsing for 60 sec, twice daily for 60 days.
 Procedure: HOT SALT WATER
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.
Experimental: POTASSIUM PERMANGANATE
0.01% POTASSIUM PERMANGANATE, 10ml used for rinsing for 60 sec, twice daily for 60 days.
 Procedure: POTASSIUM PERMANGANATE
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.
Active Comparator: CHLORHEXIDINE
0.2% CHLORHEXIDINE, 10ml used for rinsing for 60 sec, twice daily for 60 days.
 Procedure: CHLORHEXIDINE
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.


Outcome Measures
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Primary Outcome Measures :
  1. Plaque Index [ Time Frame: baseline ]
    4 sites of all tooth is observed


Secondary Outcome Measures :
  1. Plaque Index [ Time Frame: 2weeks ]
    4 sites of all tooth is observed

  2. Plaque Index [ Time Frame: 4weeks ]
    4 sites of all tooth is observed

  3. Plaque Index [ Time Frame: 6weeks ]
    4 sites of all tooth is observed

  4. Plaque Index [ Time Frame: 8weeks ]
    4 sites of all tooth is observed

  5. Gingival Index [ Time Frame: baseline ]
    4 sites of all tooth is observed

  6. Gingival Index [ Time Frame: 2weeks ]
    4 sites of all tooth is observed

  7. Gingival Index [ Time Frame: 4weeks ]
    4 sites of all tooth is observed

  8. Gingival Index [ Time Frame: 6weeks ]
    4 sites of all tooth is observed

  9. Gingival Index [ Time Frame: 8weeks ]
    4 sites of all tooth is observed

  10. Periodontal Probing Depth [ Time Frame: baseline ]
    6 sites of all tooth is observed

  11. Periodontal Probing Depth [ Time Frame: 2weeks ]
    6 sites of all tooth is observed

  12. Periodontal Probing Depth [ Time Frame: 4weeks ]
    6 sites of all tooth is observed

  13. Periodontal Probing Depth [ Time Frame: 6weeks ]
    6 sites of all tooth is observed

  14. Periodontal Probing Depth [ Time Frame: 8weeks ]
    6 sites of all tooth is observed


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02546804


Locations
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India
Agrima Singh
Indore, Madhya Pradesh, India, 452001
Sponsors and Collaborators
Government College of Dentistry, Indore
Investigators
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Principal Investigator: agrima singh Government College of Dentistry
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

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Responsible Party: Agrima Singh, P.G. Student, Government College of Dentistry, Indore
ClinicalTrials.gov Identifier: NCT02546804    
Other Study ID Numbers: GCDIndore
First Posted: September 11, 2015    Key Record Dates
Last Update Posted: August 6, 2018
Last Verified: August 2018
Additional relevant MeSH terms:
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Gingivitis
Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Infections
 Gingival Diseases
Chlorhexidine
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants