| CTRI Number |
CTRI/2025/09/094783 [Registered on: 15/09/2025] Trial Registered Prospectively |
| Last Modified On: |
14/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to see the effects of homoeopathic medicine Silicea and Homeodent tooth paste on red swollen gums in teenage patients. |
|
Scientific Title of Study
|
A study to assess the effectiveness of Silicea and Homeodent tooth paste in the treatment of Gingivitis in adolescents - a randomized clinical comparative study |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Supriya Vishnu Jadhav |
| Designation |
Assistant Professor Dept of Case Taking and Repertory |
| Affiliation |
Assistant Professor Dept of Case Taking and Repertory Kle Homeopathic Medical College and Hospital, Yellur Road, Belagavi |
| Address |
Kle Homeopathic Medical College and Hospital, kle CCH, Yellur Road, Belagavi
Belgaum
KARNATAKA
590005
India |
| Phone |
7026506361 |
| Fax |
|
| Email |
drsupriyajadhav28@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Supriya Vishnu Jadhav |
| Designation |
Assistant Professor Dept of Case Taking and Repertory |
| Affiliation |
Assistant Professor Dept of Case Taking and Repertory Kle Homeopathic Medical College and Hospital, Yellur Road, Belagavi |
| Address |
Kle Homeopathic Medical College and Hospital, Yellur Road, Belagavi
Belgaum
KARNATAKA
590005
India |
| Phone |
7026506361 |
| Fax |
|
| Email |
drsupriyajadhav28@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Supriya Vishnu Jadhav |
| Designation |
Assistant Professor Dept of Case Taking and Repertory |
| Affiliation |
Assistant Professor Dept of Case Taking and Repertory Kle Homeopathic Medical College and Hospital, Yellur Road, Belagavi |
| Address |
Kle Homeopathic Medical College and Hospital, Yellur Road, Belagavi
Belgaum
KARNATAKA
590005
India |
| Phone |
7026506361 |
| Fax |
|
| Email |
drsupriyajadhav28@gmail.com |
|
|
Source of Monetary or Material Support
|
| R and D Cell, KAHER, Belagavi |
|
|
Primary Sponsor
|
| Name |
R and D Cell, KAHER, Belagavi |
| Address |
Kle Homeopathic Medical College and Hospital, Yellur Road, Belagavi
|
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Supriya Jadhav |
Kle Homoeopathic Medical College and hospital |
KLE centenary charitable hospital,4th floor, paediatric opd.yellur road, Belagavi 590005,
Belgaum
KARNATAKA |
7026506361
drsupriyajadhav28@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee for research on human subjects |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: K050||Acute gingivitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
homeodent tooth paste |
homeodent tooth paste twice daily |
| Intervention |
silicea 30 |
silicea 30 twice daily for two weeks |
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
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.
|
|
| ExclusionCriteria |
| Details |
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/chewingsupari, panparag).
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Combined approach of Homeodent Toothpaste and homeopathic medicine Silicea is effective in management of gingivitis |
at 15th day and at 30th day |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
22/10/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
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. |