| 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
|
|
|
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
|
|
|
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 |