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

Periodontitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02546804
• Other study ID #: GCDIndore
• Status: Completed
• Phase: N/A
• Start date: June 2015
• Est. completion date: December 2015

Study information

• Verified date: August 2018
• Source: Government College of Dentistry, Indore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: December 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Gingivitis
• Periodontitis

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
India	Agrima Singh	Indore	Madhya Pradesh

Sponsors (1)

Lead Sponsor	Collaborator
Government College of Dentistry, Indore

Country where clinical trial is conducted

India, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plaque Index	4 sites of all tooth is observed	baseline
Secondary	Plaque Index	4 sites of all tooth is observed	2weeks
Secondary	Plaque Index	4 sites of all tooth is observed	4weeks
Secondary	Plaque Index	4 sites of all tooth is observed	6weeks
Secondary	Plaque Index	4 sites of all tooth is observed	8weeks
Secondary	Gingival Index	4 sites of all tooth is observed	baseline
Secondary	Gingival Index	4 sites of all tooth is observed	2weeks
Secondary	Gingival Index	4 sites of all tooth is observed	4weeks
Secondary	Gingival Index	4 sites of all tooth is observed	6weeks
Secondary	Gingival Index	4 sites of all tooth is observed	8weeks
Secondary	Periodontal Probing Depth	6 sites of all tooth is observed	baseline
Secondary	Periodontal Probing Depth	6 sites of all tooth is observed	2weeks
Secondary	Periodontal Probing Depth	6 sites of all tooth is observed	4weeks
Secondary	Periodontal Probing Depth	6 sites of all tooth is observed	6weeks
Secondary	Periodontal Probing Depth	6 sites of all tooth is observed	8weeks