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

August 3, 2018 updated by: Agrima Singh, Government College of Dentistry, Indore

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Plaque Index
Time Frame: baseline
4 sites of all tooth is observed
baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Plaque Index
Time Frame: 2weeks
4 sites of all tooth is observed
2weeks
Plaque Index
Time Frame: 4weeks
4 sites of all tooth is observed
4weeks
Plaque Index
Time Frame: 6weeks
4 sites of all tooth is observed
6weeks
Plaque Index
Time Frame: 8weeks
4 sites of all tooth is observed
8weeks
Gingival Index
Time Frame: baseline
4 sites of all tooth is observed
baseline
Gingival Index
Time Frame: 2weeks
4 sites of all tooth is observed
2weeks
Gingival Index
Time Frame: 4weeks
4 sites of all tooth is observed
4weeks
Gingival Index
Time Frame: 6weeks
4 sites of all tooth is observed
6weeks
Gingival Index
Time Frame: 8weeks
4 sites of all tooth is observed
8weeks
Periodontal Probing Depth
Time Frame: baseline
6 sites of all tooth is observed
baseline
Periodontal Probing Depth
Time Frame: 2weeks
6 sites of all tooth is observed
2weeks
Periodontal Probing Depth
Time Frame: 4weeks
6 sites of all tooth is observed
4weeks
Periodontal Probing Depth
Time Frame: 6weeks
6 sites of all tooth is observed
6weeks
Periodontal Probing Depth
Time Frame: 8weeks
6 sites of all tooth is observed
8weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Government College of Dentistry, Indore

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: agrima singh, Government College of Dentistry

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 26, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 9, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 11, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 6, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 3, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GCDIndore

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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