A Clinical Trial to Study the Effects of Two Home Made Mouthwashes in Patients With Gum Diseases
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ClinicalTrials.gov Identifier: NCT02546804 |
Recruitment Status :
Completed
First Posted : September 11, 2015
Last Update Posted : August 6, 2018
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Condition or disease | Intervention/treatment | Phase |
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Gingivitis Periodontitis | Procedure: HOT SALT WATER Procedure: POTASSIUM PERMANGANATE Procedure: CHLORHEXIDINE | Not Applicable |
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 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 |

Arm | Intervention/treatment |
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Experimental: HOT SALT WATER
3% HOT SALT WATER , 25ml used for rinsing for 60 sec, twice daily for 60 days.
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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.
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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.
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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. |
- Plaque Index [ Time Frame: baseline ]4 sites of all tooth is observed
- Plaque Index [ Time Frame: 2weeks ]4 sites of all tooth is observed
- Plaque Index [ Time Frame: 4weeks ]4 sites of all tooth is observed
- Plaque Index [ Time Frame: 6weeks ]4 sites of all tooth is observed
- Plaque Index [ Time Frame: 8weeks ]4 sites of all tooth is observed
- Gingival Index [ Time Frame: baseline ]4 sites of all tooth is observed
- Gingival Index [ Time Frame: 2weeks ]4 sites of all tooth is observed
- Gingival Index [ Time Frame: 4weeks ]4 sites of all tooth is observed
- Gingival Index [ Time Frame: 6weeks ]4 sites of all tooth is observed
- Gingival Index [ Time Frame: 8weeks ]4 sites of all tooth is observed
- Periodontal Probing Depth [ Time Frame: baseline ]6 sites of all tooth is observed
- Periodontal Probing Depth [ Time Frame: 2weeks ]6 sites of all tooth is observed
- Periodontal Probing Depth [ Time Frame: 4weeks ]6 sites of all tooth is observed
- Periodontal Probing Depth [ Time Frame: 6weeks ]6 sites of all tooth is observed
- Periodontal Probing Depth [ Time Frame: 8weeks ]6 sites of all tooth is observed

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

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
India | |
Agrima Singh | |
Indore, Madhya Pradesh, India, 452001 |
Principal Investigator: | agrima singh | Government College of Dentistry |
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 |
Gingivitis Periodontitis Periodontal Diseases Mouth Diseases Stomatognathic Diseases Infections |
Gingival Diseases Chlorhexidine Anti-Infective Agents, Local Anti-Infective Agents Disinfectants |