| CTRI Number |
CTRI/2025/02/080840 [Registered on: 18/02/2025] Trial Registered Prospectively |
| Last Modified On: |
18/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
effect of herbal agent plantago major and CMCP on tooth pain |
|
Scientific Title of Study
|
Comparative evaluation of novel organic agent plantago major & CMCP as intracanal medicament: A randomised control 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 |
vinay jainath sharma |
| Designation |
Assosciate Profesor,dept of Conservative dentistry & endodontics |
| Affiliation |
Maharashtra university of health sciences , Nashik |
| Address |
DEPT OF CONSERVATIVE DENTISTRY & ENDODONTICS , ROOM NO 201 SMBT IDSR ,NANDI HILL DHAMANGAON
Nashik
MAHARASHTRA
422403
India |
| Phone |
9822213054 |
| Fax |
|
| Email |
vsvisualise8@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
vinay jainath sharma |
| Designation |
Assosciate Profesor,dept of Conservative dentistry & endodontics |
| Affiliation |
Maharashtra university of health sciences , nashik |
| Address |
DEPT OF CONSERVATIVE DENTISTRY & ENDODONTICS , ROOM NO 201 SMBT IDSR ,NANDI HILL DHAMANGAON
Nashik
MAHARASHTRA
422403
India |
| Phone |
9822213054 |
| Fax |
|
| Email |
vsvisualise8@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vinay sharma |
| Designation |
Associate profesor,dept of Conservative dentistry & endodontics |
| Affiliation |
Maharashtra univeristy of health science, nashik |
| Address |
DEPT OF CONSERVATIVE DENTISTRY & ENDODONTICS ,room no 201,SMBT IDSR ,NANDI HILL DHAMANGAON
Nashik
MAHARASHTRA
422403
India |
| Phone |
09822213054 |
| Fax |
|
| Email |
vsvisualise8@gmail.com |
|
|
Source of Monetary or Material Support
|
| dept of conservative dentistry and endodontics room no 201, SMBT IDSR,nandi hill , Dhamangaon ,nashik |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 |
| vinay sharma |
SMBT Institute Of Dental Sciences & Research |
Department of Conservative Dentistry & Endodontics, room no 201,SMBT IDSR ,nandi hills ,Dhamangaon
Nashik
MAHARASHTRA |
9822213054
vsvisualise8@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| InstitutionalEthicallCommitte SMBT IDSR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
heathy human with age 25-50 yrs with pulpitis cases on molars teeth were selected |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
CMCP( CHAMPOR MONO CHLORO PHENOL) |
CMCP is used as comparative agent as intracanal medicament in pulpitis cases |
| Intervention |
plantago major |
homeopathic agent plantago major is used as intracanal medicament and added in molar in pulpitis |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
50 patients equally divided males and females(25-50 age group) were randomly selected from OPD (acute irreversible pulpitis & acute apical periodontitis in molars) with severe pain
|
|
| ExclusionCriteria |
| Details |
teeth with swelling, periapical lesion, incomplete root formation were excluded from study |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to asses effect of plantago major a novel homeopathic agent as potent intracanal medicament used in endodontics procedure |
data assesed on day 2 and day 7 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to proof plantago major as potent anti inflammatory agent |
data assessed on day 1 and 7 |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
03/03/2025 |
| 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="0"
Months="0"
Days="7" |
|
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
|
Comparative evaluation of novel organic
agent plantago major & CMCP as intracanal medicament – A randomised control trial,a is study in which plantago major a homeopathic agent is used for first time in endodontics as intracanal medicament and is compared with CMCP . each group were assessed on day 1 and day 7 for pain in pulpitis cases.
|