A study to assess the effectiveness of Silicea and Homeodent tooth paste in the treatment of Gingivitis in adolescents - a randomized clinical comparative study

Gingivitis is common and mild form of gum disease characterized by red swollen and bleeding gum. Epidemiological studies indicate that gingivitis is frequently observed in children and adolescents The recent lifestyle changes seen in the younger generation are known to cause both a positive and negative impact on health. According to research studies changes in lifestyle, response to stressful situations including diet and over use of antibiotics are responsible for inflammation and disturbances in resoleomics.

Homoeopathy is proven effective to treat gingivitis. Also, many homoeopathic formulations are available which are useful in relieving pain. There are no research articles which provides the evidence of combined effect of Homeodent Toothpaste and silicea. So this noval study is designed.

OBJECTIVES:

-To study the effectiveness of Homeodent Toothpaste on Gingivitis.

-To study the effectiveness of homoeopathic medicine Silicea along with Homeodent Toothpaste on Gingivitis.

 STUDY DESIGN: Randomized clinical trial.

TYPE OF STUDY: Single centric interventional comparative study.

STUDY PERIOD: 30 days.

STUDY CENTER: OPD and IPD of K.L.E. Homeopathic Hospital and Medical Research Centre, Yellur Road, Belagavi.

DURATION OF THE STUDY: 2 year.

SAMPLE SIZE: Total number of patients are 60, meeting all inclusion and exclusion criteria will be included for the study (30 in each group).

Group A : Homeodent toothpaste + placebo

Group B: Homeodent toothpaste + silicea30

SAMPLE DESIGN: Random sampling

INCLUSION CRITERIA:

1.     Individuals between the age group of 13 to 18 years with signs and symptoms of gingivitis will be included in the study.

2.     Patients with OHI-S index fair and good will be included in the study.

EXCLUSION CRITERIA:

1.     Patient with presence of advanced periodontal disease.

2.     Patients with orthodontic appliances.

3.     Patients with history of respiratory infections, kidney diseases, diabetes.

4.     Patients with a history of hospitalization or intake of medicines in last 3 months.

5.     Patients with current habits (eating/chewing supari, pan parag).

OBJECTIVE PARAMETERS:

1.     Gingival bleeding index

2.     Oral hygiene index (OHI-S index)

ASSESSMENT CRITERIA:

Before and after treatment for a period of 30 days:

1.     Changes in the subjective parameters on day 0, day 15, and day 30.

2.     Changes in the objective parameters on day 0, day 15 and day 30.