| CTRI Number |
CTRI/2020/09/027857 [Registered on: 17/09/2020] Trial Registered Prospectively |
| Last Modified On: |
11/09/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Propolis as pulpotomy agent for primary teeth |
|
Scientific Title of Study
|
In-vivo study to evaluate and compare the efficacy of various pulpotomy agents: formocresol, ferric sulfate and propolis as pulpotomy medicaments in vital primary molars of children in the age group of 4-9 years, both clinically and radiographically |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ankita Yadav |
| Designation |
MDS student |
| Affiliation |
SGT University |
| Address |
Department of pedodontics and preventive dentistry,Faculty of Dental sciences,SGT University
Gurgaon
HARYANA
122505
India |
| Phone |
9136061999 |
| Fax |
|
| Email |
ankita.yadav5686@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ankit Srivastva |
| Designation |
Reader |
| Affiliation |
SGT University |
| Address |
Department of pedodontics and preventive dentistry,Faculty of Dental sciences,SGT University
Gurgaon
HARYANA
122505
India |
| Phone |
8130023844 |
| Fax |
|
| Email |
drankitsri@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ankita Yadav |
| Designation |
MDS student |
| Affiliation |
SGT University |
| Address |
Department of pedodontics and preventive dentistry,Faculty of Dental sciences,SGT University
Gurgaon
HARYANA
122505
India |
| Phone |
9136061999 |
| Fax |
|
| Email |
ankita.yadav5686@gmail.com |
|
|
Source of Monetary or Material Support
|
| SGT University,Chandu-Budhera,Gurugram |
|
|
Primary Sponsor
|
| Name |
SGT |
| Address |
Faculty of Dental sciences,SGT University,Gurugram-122505 |
| 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 |
| Ankita Yadav |
Faculty of dental sciences,SGT University,Gurugram |
Department of pediatric dentistry,room no.6,Dr.Ankita Yadavs chair
Gurgaon
HARYANA |
9136061999
ankita.yadav5686@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Faculty of dental sciences ethical committee,SGT university |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Deeply carious primary molars |
| Patients |
(1) ICD-10 Condition: K029||Dental caries, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
N/A |
N/A |
| Intervention |
Propolis |
Standardized Propolis Extract will be mixed with 1.75mL of polyethylene glycol will be compared to formocresol and 15.5% ferric sulfate at an interval of 3momths,6months,9months and 12months |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
Pulpotomy will be performed with three materials i.e. formocresol,ferric sulfate and propolis in primary molars followed by GIC and stainless steel crowns |
|
| ExclusionCriteria |
| Details |
1.History of systemic disease.
2.Teeth showing clinical evidence of spontaneous or nocturnal pain, tenderness to percussion, pathological mobility, swelling or fistulous tract.
3.Radiographical evidence of periodontal ligament space widening, internal root resorption. External root resorption, furcal radiolucency/inter-radicular bone destruction and/or periapical bone destruction.
4.Teeth requiring more than 5 minutes to achieve hemostasis during clinical procedure.
5.History of known allergy to pollens associated with propolis.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Not applicable |
Not applicable |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not applicable |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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)
|
22/09/2020 |
| 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="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Present randomized controlled trial will be carried out in 45 children in the age group of 4-9 years with deep carious lesion in primary molars. Pulpotomy procedure will be carried out to
evaluate and compare the efficacy of formocresol,
ferric sulfate and propolis as pulpotomy medicament both clinically and radiographically. |