Clinical trial NCT02546804: 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
Overall status: COMPLETED
Phase: NA
Conditions: Gingivitis
Periodontitis
Lead sponsor: Government College of Dentistry, Indore
Sponsor class: OTHER
First posted: 2015-09-11
Enrollment: 90
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Plaque Index
timeFrame: baseline
Secondary outcomes:
measure: Plaque Index
timeFrame: 2weeks
measure: Plaque Index
timeFrame: 4weeks
measure: Plaque Index
timeFrame: 6weeks
measure: Plaque Index
timeFrame: 8weeks
measure: Gingival Index
timeFrame: baseline
measure: Gingival Index
timeFrame: 2weeks
measure: Gingival Index
timeFrame: 4weeks
measure: Gingival Index
timeFrame: 6weeks
measure: Gingival Index
timeFrame: 8weeks
measure: Periodontal Probing Depth
timeFrame: baseline
measure: Periodontal Probing Depth
timeFrame: 2weeks
measure: Periodontal Probing Depth
timeFrame: 4weeks
measure: Periodontal Probing Depth
timeFrame: 6weeks
measure: Periodontal Probing Depth
timeFrame: 8weeks
Other outcomes:
Locations:
city: Indore
country: India
facility: Agrima Singh
state: Madhya Pradesh
Study officials:
affiliation: Government College of Dentistry
name: agrima singh
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.