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

Primary Purpose

Gingivitis, Periodontitis

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
HOT SALT WATER
POTASSIUM PERMANGANATE
CHLORHEXIDINE
Sponsored by
Government College of Dentistry, Indore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Gingivitis

Eligibility Criteria

21 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Agrima Singh

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

HOT SALT WATER

POTASSIUM PERMANGANATE

CHLORHEXIDINE

Arm Description

3% HOT SALT WATER , 25ml used for rinsing for 60 sec, twice daily for 60 days.

0.01% POTASSIUM PERMANGANATE, 10ml used for rinsing for 60 sec, twice daily for 60 days.

0.2% CHLORHEXIDINE, 10ml used for rinsing for 60 sec, twice daily for 60 days.

Outcomes

Primary Outcome Measures

Plaque Index
4 sites of all tooth is observed

Secondary Outcome Measures

Plaque Index
4 sites of all tooth is observed
Plaque Index
4 sites of all tooth is observed
Plaque Index
4 sites of all tooth is observed
Plaque Index
4 sites of all tooth is observed
Gingival Index
4 sites of all tooth is observed
Gingival Index
4 sites of all tooth is observed
Gingival Index
4 sites of all tooth is observed
Gingival Index
4 sites of all tooth is observed
Gingival Index
4 sites of all tooth is observed
Periodontal Probing Depth
6 sites of all tooth is observed
Periodontal Probing Depth
6 sites of all tooth is observed
Periodontal Probing Depth
6 sites of all tooth is observed
Periodontal Probing Depth
6 sites of all tooth is observed
Periodontal Probing Depth
6 sites of all tooth is observed

Full Information

First Posted
August 26, 2015
Last Updated
August 3, 2018
Sponsor
Government College of Dentistry, Indore
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1. Study Identification

Unique Protocol Identification Number
NCT02546804
Brief Title
A Clinical Trial to Study the Effects of Two Home Made Mouthwashes in Patients With Gum Diseases
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
June 2015 (Actual)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Government College of Dentistry, Indore

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingivitis, Periodontitis

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HOT SALT WATER
Arm Type
Experimental
Arm Description
3% HOT SALT WATER , 25ml used for rinsing for 60 sec, twice daily for 60 days.
Arm Title
POTASSIUM PERMANGANATE
Arm Type
Experimental
Arm Description
0.01% POTASSIUM PERMANGANATE, 10ml used for rinsing for 60 sec, twice daily for 60 days.
Arm Title
CHLORHEXIDINE
Arm Type
Active Comparator
Arm Description
0.2% CHLORHEXIDINE, 10ml used for rinsing for 60 sec, twice daily for 60 days.
Intervention Type
Procedure
Intervention Name(s)
HOT SALT WATER
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
POTASSIUM PERMANGANATE
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
CHLORHEXIDINE
Intervention Description
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.
Primary Outcome Measure Information:
Title
Plaque Index
Description
4 sites of all tooth is observed
Time Frame
baseline
Secondary Outcome Measure Information:
Title
Plaque Index
Description
4 sites of all tooth is observed
Time Frame
2weeks
Title
Plaque Index
Description
4 sites of all tooth is observed
Time Frame
4weeks
Title
Plaque Index
Description
4 sites of all tooth is observed
Time Frame
6weeks
Title
Plaque Index
Description
4 sites of all tooth is observed
Time Frame
8weeks
Title
Gingival Index
Description
4 sites of all tooth is observed
Time Frame
baseline
Title
Gingival Index
Description
4 sites of all tooth is observed
Time Frame
2weeks
Title
Gingival Index
Description
4 sites of all tooth is observed
Time Frame
4weeks
Title
Gingival Index
Description
4 sites of all tooth is observed
Time Frame
6weeks
Title
Gingival Index
Description
4 sites of all tooth is observed
Time Frame
8weeks
Title
Periodontal Probing Depth
Description
6 sites of all tooth is observed
Time Frame
baseline
Title
Periodontal Probing Depth
Description
6 sites of all tooth is observed
Time Frame
2weeks
Title
Periodontal Probing Depth
Description
6 sites of all tooth is observed
Time Frame
4weeks
Title
Periodontal Probing Depth
Description
6 sites of all tooth is observed
Time Frame
6weeks
Title
Periodontal Probing Depth
Description
6 sites of all tooth is observed
Time Frame
8weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
agrima singh
Organizational Affiliation
Government College of Dentistry
Official's Role
Principal Investigator
Facility Information:
Facility Name
Agrima Singh
City
Indore
State/Province
Madhya Pradesh
ZIP/Postal Code
452001
Country
India

12. IPD Sharing Statement

Citations:
PubMed Identifier
26059709
Citation
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.
Results Reference
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PubMed Identifier
25059640
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.
Results Reference
background

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

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