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

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

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.

Study Overview

• Status: Completed
• Conditions: Periodontitis; Gingivitis
• Intervention / Treatment: Procedure: HOT SALT WATER; Procedure: POTASSIUM PERMANGANATE; Procedure: CHLORHEXIDINE

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 Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Madhya Pradesh
    • Indore, Madhya Pradesh, India, 452001
      • Agrima Singh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Government College of Dentistry, Indore
• Investigators: Principal Investigator: agrima singh, Government College of Dentistry

Publications and helpful links

General Publications

• Resende MM, Rocha CA, Correa 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2015
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: August 26, 2015
• First Submitted That Met QC Criteria: September 9, 2015
• First Posted (Estimate): September 11, 2015

Study Record Updates

• Last Update Posted (Actual): August 6, 2018
• Last Update Submitted That Met QC Criteria: August 3, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Periodontitis; Gingivitis; Anti-Infective Agents, Local; Anti-Infective Agents; Disinfectants; Chlorhexidine
• Other Study ID Numbers: GCDIndore