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CTRI Number  CTRI/2025/04/084991 [Registered on: 16/04/2025] Trial Registered Prospectively
Last Modified On: 17/10/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Homoeopathic treatment of inflammation of gums in school children  
Scientific Title of Study   Role of individualized Homoeopathy in treatment of gingivitis in school children aged 10-16 years-A pilot single blind randomized placebo control trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Neha kalra  
Designation  Research officer  
Affiliation  Central council of research in Homoeopathy  
Address  Central council of research in Homoeopathy ,Janakpuri ,New Delhi Homoeopathic Department, Fourth floor ,Technical division Room no:418 West DELHI 110058 India

West
DELHI
110058
India 
Phone  9810518111  
Fax    
Email  drnehamehta1985@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Neha kalra  
Designation  Research officer  
Affiliation  Central council of research in Homoeopathy  
Address  Central council of research in Homoeopathy ,Janakpuri ,New Delhi Homoeopathic Department, Fourth floor ,Technical division Room no:418 West DELHI 110058 India

West
DELHI
110058
India 
Phone  9810518111  
Fax    
Email  drnehamehta1985@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Neha kalra  
Designation  Research officer  
Affiliation  Central council of research in Homoeopathy  
Address  Central council of research in Homoeopathy ,Janakpuri ,New Delhi Homoeopathic Department, Fourth floor ,Technical division Room no:418 West DELHI 110058 India

West
DELHI
110058
India 
Phone  9810518111  
Fax    
Email  drnehamehta1985@gmail.com  
 
Source of Monetary or Material Support  
Central council of research in Homoeopathy ,Janakpuri ,New Delhi 110058 
 
Primary Sponsor  
Name  Central council of research in Homoeopathy ,Janakpuri ,New Delhi  
Address  Central council of research in Homoeopathy ,Janakpuri ,New Delhi  
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ritika  Kendriya Vidyalaya, Rashtrapati bhavan  1Dr Rajendra Prasad Kendriya Vidyalaya, medical room no:26, Presidents Estate near Gate No.30, New Delhi, Delhi 110004 New Delhi DELHI 2cambridge foundation school medical room no5 new delhi 110027
Central
DELHI 
9818532243

drritika.singhal91@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
CENTRAL ETHICS COMMITTEE  No Objection Certificate 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  gingivitis 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Individualized Homoeopathic medicine  4 pills medicated with Indicated Homoeopathic medicine in centesimal potency based on homoeopathic principles 
Comparator Agent  placebo  4 pills medicated with placebo based on Homoeopathic principles 
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  16.00 Year(s)
Gender  Both 
Details  1.Children aged 10-16 years
2.Both genders
3. Children presenting with gingivitis I, II, III
type/complaints of inflammation, bleeding or
swelling of gums, bad breath, brown/yellow
staining of teeth.
4.Children having no previous history of dental
intervention (scaling)/taking any other oral
medication/antibiotic past 01 month/mouth
rinsing agents.
5.Children/parents/guardians willing to give
written informed consent/assent to
participate in the study 
 
ExclusionCriteria 
Details  1.Diagnosed cases suffering from systemic
illness such as diabetes, HIV infection,
cardiovascular disease, hereditary gingival
fibromatosis, acquired immunodeficiency
syndrome, granulomatous disorders such as
Crohn disease and Melkersson–Rosenthal
syndrome, acute monocytic leukemia,
tuberous sclerosis, fibrous/epithelial
hyperplasia or benign neoplasm of
periodontal ligament, Congenital Gum
Synechiae, Congenital Epulis, anxiety,
depression, emotional stress, sleep
deprivation, Varicella herpes virus infection,
Epstein - Barr virus infection, coxsackie group
A viruses infection, Wegeners
Granulomatosis, acute ulcerative
necrotizinggingivitis,lineargingivalerythema,a
cuteherpeticgingiva-stomatitis ,candidiasis
infection
2.Nutritionaldeficiencyinducedgingivitis(vitamin
AandC),cancrumoris,druginduced gingivitis,
gingivitis associated with abscess and
attachment loss (periodontitis), traumatic
gingivitis, muco-gingival deformities.
3.Children using medicated or herbal
toothpaste
4.Children with history ofsmoking and/or
Tobacco chewing 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Gingival index
(GI)score
 
Baseline,3rd week,6th week,9th week,12th week 
 
Secondary Outcome  
Outcome  TimePoints 
Plaque index (PI)  Baseline,3rd week,6th week,9th week,12th week 
To outline the frequently indicated homoeopathic medicines in
treatment of gingivitis. 
after 3 months 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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   Phase 2 
Date of First Enrollment (India)   07/05/2025 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
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   Gingivitisis an inflammatory condition of gums. The symptoms of gingivitis are swelling, redness, halitosis, bleeding gums often associated while brushing the teeth. The most common form of gingivitis occurs due to bacterial biofilms on tooth surfaces known as plaque .Plaque accumulation is seen mostly along the cervical margins and is the result of poor oral hygiene. Other causes associated with gingivitis are systemic, hereditary, hormonal, viral, fungal infections and nutritional deficiencies. The prevalence and severity of gingivitis in school students aged 6–11 years in Jordan is 38.5 % mild gingivitis, 31.4 % moderate gingivitis and 0.3 % severe gingivitis.
Gingivitis can be prevented through regular oral hygiene, brushing, mouth washes and toothpaste containing triclosan. Plaque when hardens forms calculus which can only be removed by dental professionals through scaling, root planning, curettage and mouth washes. Gingivitis is a non-destructive and reversible condition, however if not taken care may lead to periodontitis, abscess and ulcerative conditions of surrounding tissues and bones, tooth loss, chronic gingivitis.
Favorable dental health related behaviors are best established in pre-adolescent and adolescent age group and once established, offer promising resultsin improving one’s quality of life ahead. Schools provide an ideal setting to deliver oral health education and implementation of interventional programs in a cost effective and efficient manner.
One of the preclinical study namely “Antibacterial activity of homeopathic medications Lycopodium clavatum and Arsenicum album against periodontal bacteria” concludes that Arsenic album and Lycopodium clavatum tinctures are potent antimicrobials against five bacterial strains of the oral cavity. The study lacks in-vivo validation of the results. A review article on “Homoeopathy in Pediatric dentistry” shows that Homoeopathy can be used as a complementary therapy in dental ailments but no case studies were carried outfurther on it. Another review article “Complementary and alternative medicinesin oral health care” mentions use of Homoeopathic medicinesin various oro-facial disorders
The study has been proposed to validate the role of Homoeopathy in treating gingivitis successfully. It can offer not only a cost effective treatment but also avoid unnecessary use of antibiotics and mouthwashes which are often not preferred by dentist for children in respective age groups 
 
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