| CTRI Number |
CTRI/2025/08/093928 [Registered on: 29/08/2025] Trial Registered Prospectively |
| Last Modified On: |
28/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Homeopathic Medicines for Pain Relief in Dental Caries. |
|
Scientific Title of Study
|
Efficacy of Individualized Homeopathic Medicines in Managing Pain of Dental Caries in Teenagers and Adults: A Double-blind, Randomized, Placebo-controlled Trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Md Sayed |
| Designation |
Postgraduate Trainee |
| Affiliation |
D N De Homoeopathic Medical College and Hospital |
| Address |
12, Gobinda Khatick Road, Tangra, Kolkata, 700046, West Bengal,
India.
12, Gobinda Khatick Road, Tangra, Kolkata ,700046, West Bengal,
India.
Kolkata
WEST BENGAL
700046
India |
| Phone |
7031030180 |
| Fax |
|
| Email |
mdsayed.236@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Md Sayed |
| Designation |
Postgraduate Trainee |
| Affiliation |
D N De Homoeopathic Medical College and Hospital |
| Address |
12, Gobinda Khatick Road, Tangra, Kolkata ,700046, West Bengal,
India.
12, Gobinda Khatick Road, Tangra, Kolkata ,700046, West Bengal,
India.
Kolkata
WEST BENGAL
700046
India |
| Phone |
7031030180 |
| Fax |
|
| Email |
mdsayed.236@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Md Sakhawat Hossain |
| Designation |
Professor and Head |
| Affiliation |
D N De Homoeopathic Medical College and Hospital |
| Address |
12, Gobinda Khatick Road, Tangra, Kolkata ,700046, West Bengal,
India.
12, Gobinda Khatick Road, Tangra, Kolkata ,700046, West Bengal,
India.
Kolkata
WEST BENGAL
700046
India |
| Phone |
9433852961 |
| Fax |
|
| Email |
imdrmsh@gmail.com |
|
|
Source of Monetary or Material Support
|
| D N De Homoeopathic Medical College and Hospital, Govt. of WB, 12, Gobinda Khatick Road, Tangra, Kolkata, West Bengal, India,700046 . |
|
|
Primary Sponsor
|
| Name |
D N De Homoeopathic Medical College and Hospital |
| Address |
12, Gobinda Khatick Road, Tangra, Kolkata 700046. |
| Type of Sponsor |
Government medical college |
|
|
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 Md Sayed |
D N De Homoeopathic Medical College and Hospital |
Dept. of
Materia Medica, OPD 6
(Dental), and PG 2,
12, Gobinda
Khatick Road,
Tangra, Kolkata
700046
Kolkata
WEST BENGAL
Kolkata
WEST BENGAL |
7031030180
mdsayed.236@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of D N De Homoeopathic Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K029||Dental caries, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Identical-Looking Placebo |
This group will be given placebos that look just like verum. Four cane sugar globules no. 40, moistened with 90% v/v ethanol, will be the dosage for each dose. These should be taken orally on an empty stomach, with a clean tongue. The dosage and frequency of administration will be determined by the specific needs of each case. All the medicines and sundry items will be procured from a Good Manufacturing Practice (GMP) certified firm. Duration of the therapy is two weeks. Following a repackaging process in matching glass bottles bearing the code, drug name, and potency labels, the medications and placebos will be administered in accordance with the random number list.
Concomitant care: All participants will receive standard oral hygiene advice (toothbrushing twice daily with fluoride toothpaste and flossing). The routine use of other mouth rinses or over-the-counter analgesics will not be permitted during the trial period unless indicated as rescue medication. The time and dose of rescue paracetamol will be documented and considered during analysis. No other systemic analgesics, antibiotics, or herbal/homeopathic remedies (other than the test medication) will be permitted unless clinically warranted.
Diet: patients will be advised to take food rich in vitamin C (Indian gooseberry, citrus fruit, such as limes, oranges)
Duration of therapy: 2 weeks |
| Intervention |
Individualized Homoeopathic Medicines |
The recommended homoeopathic medications will be administered at centesimal potencies (cH) as part of the planned intervention. Each dose will consist of 4 cane sugar globules no. 40 moistened with the indicated medicine (preserved in 90% v/v ethanol), to be taken orally on clean tongue in empty stomach; dosage and repetition depending upon the individual requirement of the cases. Patients will be advised to refrain from handling the globules or from eating, drinking, smoking or brushing teeth within 30 minutes of taking the globules and will be asked to suck the globules rather than simply swallowing those. Single individualized medicine will be prescribed on each occasion taking into account presenting symptom totality, clinical history details, constitutional features, miasmatic expressions, repertorization using HOMPATH/RADAR® software when required with due consultation of Materia Medica and due consensus among three homoeopaths. All the medicines and sundry items will be procured from a Good Manufacturing Practice (GMP) certified firm. Provision will be kept to change the medicines or potencies and adjust the dosage in subsequent visits whenever required following the principles of classical homoeopathy and such instances will be compared between groups. Concomitant care: All participants will receive standard oral hygiene advice (toothbrushing twice daily with fluoride toothpaste and flossing).The routine use of other mouth rinses or over-the-counter analgesics will not be permitted during the trial period unless indicated as rescue medication.The time and dose of rescue paracetamol will be documented and considered during analysis. No other systemic analgesics, antibiotics, or herbal/homeopathic remedies (other than the test medication) will be permitted unless clinically warranted.
Diet: patients will be advised to take food rich in vitamin C (Indian gooseberry, citrus fruit, such as limes, oranges)
Duration of therapy: 2 weeks
|
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Age 12–65 years
2. Participants of either sex or transgender.
3. Toothache from dental caries.
|
|
| ExclusionCriteria |
| Details |
1. Not providing with written informed assent and or consent of participation.
2. Other orofacial pain conditions of nonodontogenic origin.
3. Patients with Pain VAS score more or equal to 7.5 (75mm)
4. Recent steroid or antibiotic therapy for dental pain, gingivitis, periodontitis.
5. Spontaneous bleeding gum associated with the systemic disorder.
6. Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled or life threatening illness affecting the quality of life or any organ failure.
7. Pregnant and puerperal women, lactating mothers.
8. Vulnerable population that is unconscious, ambulatory, too sick for consultation.
9. Differently abled, terminally or critically ill patients, mentally incompetent people.
10. Self reported immune compromised states.
11. Already undergoing homeopathic treatment for chronic disease within last 2 weeks.
12. Tobacco chewing and or smoking, alcoholism and or any form(s) of substance abuse and/or dependence (TAPS tool)
13. Simultaneous participants in any other clinical trial.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The Pain Visual Analogue Scale (VAS) |
At Baseline, Day 2, Day 6, Day 14 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Oral health-related quality of life (OHIP-14 scores) |
At Baseline, Day 2, Day 6, Day 14 |
| International Caries Detection and Assessment System (ICDAS II) criteria |
At Baseline, Day 2, Day 6, Day 14 |
|
|
Target Sample Size
|
Total Sample Size="192"
Sample Size from India="192"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
14/09/2025 |
| 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="6"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [mdsayed.236@gmail.com].
- For how long will this data be available start date provided 01-01-2028 and end date provided 31-12-2032?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
Dental caries is a chronic, multifactorial disease driven by biofilm and acid production from bacteria like Streptococcus mutans. These bacteria convert dietary sugars into acids, mainly lactic acid, which lower the pH and lead to the breakdown of enamel and dentin by dissolving hydroxyapatite. When demineralization outweighs the natural protective effects of saliva and remineralization, carious lesions form and progress. Early signs include white spots indicating subsurface enamel demineralization. Persistent acid exposure roughens enamel and can eventually cause cavitations. Lesions may remain within enamel for 3–4 years before becoming radiographically visible. Dental pain is defined as discomfort arising from tooth structures or their supporting tissues. A double-blind, randomized (2:1), placebo-controlled trial will be conducted on 192 teenagers and adults who are suffering from pain of dental caries at the outpatient department of D. N. De Homoeopathic Medical College and Hospital. Assessment will be done by the Pain VAS Score [primary outcomes]; the Oral Health Impact Profile – 14 item version (OHIP-14) will be employed to measure the effect of oral health conditions on quality of life. [Secondary outcome] Second, change in caries status using ICDAS II (International Caries Detection and Assessment System) [secondary outcome]. Comparative analysis will be carried out to detect group differences. |