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

• ClinicalTrials.gov Identifier: NCT02546804
• Recruitment Status: Completed
• First Posted: September 11, 2015
• Last Update Posted: August 6, 2018
• Sponsor: Government College of Dentistry, Indore
• Information provided by (Responsible Party): Agrima Singh, Government College of Dentistry, Indore

Study Description

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

• 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

Arms and Interventions

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

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

• 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

Locations

India

Agrima Singh

Indore, Madhya Pradesh, India, 452001

Sponsors and Collaborators

Government College of Dentistry, Indore

Investigators

• Principal Investigator: agrima singh; Government College of Dentistry

More Information

Publications:

Resende MM, Rocha CA, Corrêa NF, Veiga RR, Passos SJ, Novo NF, Juliano Y, Damasceno CA. Tap water versus sterile saline solution in the colonisation of skin wounds. Int Wound J. 2016 Aug;13(4):526-30. doi: 10.1111/iwj.12470. Epub 2015 Jun 8.

Supranoto SC, Slot DE, Addy M, Van der Weijden GA. The effect of chlorhexidine dentifrice or gel versus chlorhexidine mouthwash on plaque, gingivitis, bleeding and tooth discoloration: a systematic review. Int J Dent Hyg. 2015 May;13(2):83-92. doi: 10.1111/idh.12078. Epub 2014 Jul 24. Review.

• 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
• Last Update Posted: August 6, 2018
• Last Verified: August 2018

Additional relevant MeSH terms:

Gingivitis; Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Infections; Gingival Diseases; Chlorhexidine; Anti-Infective Agents, Local; Anti-Infective Agents; Disinfectants