Skip to main content
OpenTrials
Completed

NCT Number: NCT02546804

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Gingivitis Gingival Diseases Infections Mouth Diseases Periodontal Diseases Periodontitis Stomatognathic Diseases

Age range

21 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Agrima Singh

Indore, Madhya Pradesh, 452001, India

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HOT SALT WATER

Procedure

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

Procedure

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

Procedure

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 outcomes

  1. Plaque Index

    Time frame: baseline

    4 sites of all tooth is observed

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Government College of Dentistry, Indore

Other

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Sep 11, 2015
Registry last updated
Aug 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.