| CTRI Number |
CTRI/2021/10/037114 [Registered on: 05/10/2021] Trial Registered Prospectively |
| Last Modified On: |
11/05/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To check the effectiveness of royal jelly as root canal filling material in childs teeth (molars) |
|
Scientific Title of Study
|
Evaluating the efficacy of Royal Jelly-zinc
oxide mixture and Royal jelly - calcium
hydroxide mixture over conventional calcium hydroxide iodoform base paste as root canal obturating material in primary molars-A randomized clinical trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
I Fausty Sharon |
| Designation |
Post Graduate Student |
| Affiliation |
SRM Dental College and Hospitals |
| Address |
SRM Dental College and Hospitals,
Bharathi Salai,
Ramapuram,
Chennai.
PG Block II , 3rd floor, Department of Pediatric and Preventive Dentistry,
Bharathi Salai,
Ramapuram,
Chennai
Chennai
TAMIL NADU
600089
India |
| Phone |
9176032337 |
| Fax |
|
| Email |
ifaustysharon@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr P Shankar |
| Designation |
Reader |
| Affiliation |
SRM dental College and Hospitals |
| Address |
SRM Dental College and Hospitals,
Bharathi Salai,
Ramapuram,
Chennai
PG Block II,
3rd Floor,Department of Pediatric and Preventive Dentistry,Bharathi salai,
Ramapuram ,Chennai
Chennai
TAMIL NADU
600089
India |
| Phone |
9884585808 |
| Fax |
|
| Email |
pedoshankar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
I Fausty Sharon |
| Designation |
Post Graduate Student |
| Affiliation |
SRM Dental College and Hospitals |
| Address |
SRM Dental College and Hospitals,
Bharathi Salai,
Ramapuram,
Chennai.
PG Block II, 3rd Floor ,Department of Pediatric and Preventive Dentistry,
Bharathi Salai,
Ramapuram,
Chennai.
Chennai
TAMIL NADU
600089
India |
| Phone |
9176032337 |
| Fax |
|
| Email |
ifaustysharon@gmail.com |
|
|
Source of Monetary or Material Support
|
| I Fausty Sharon
SRM Dental College,
Bharathi Salai,
Ramapuram,Chennai |
|
|
Primary Sponsor
|
| Name |
I Fausty Sharon |
| Address |
A1F1 VGN Ferndale,VGN Avenue,Mogappair,Chennai. |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Fausty sharon |
Departement Of Pediatric & Prevetive Dentistry |
SRM Dental College and Hospitals
PG Block II,Department Of Pediatric and Preventive Dentistry.
Bharathi Salai,
Chennai
Chennai
TAMIL NADU |
9176032337
ifaustysharon@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board (IRB)-SRM |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K040||Pulpitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Calcium Hydroxide Iodoform paste |
The main ingredients of these calcium hydroxide-iodoform paste are calcium hydroxide 30.3%, iodoform 40.4%, silicone oil 22.4%, others 6.9 %. calcium hydroxide iodoform paste tends to resorb a little faster than the physiological rate of root resorption. |
| Intervention |
Royal Jelly - Calcium Hydroxide ,
Royal Jelly - Zinc oxide |
Royal jelly is a natural secretion of young bees with remarkable anti-inflammatory,antibacterial and improved wound healing properties.The chemical composition of royal jelly include proteins,lipids and other antimicrobial elements.Royal jelly has been recognised as a dietary supplemment and is used in cosmetics for its alleged tonic and bio stimulating agents.It also exhibits anti microbial effects , suppresses allergic reactions , lowers the amount of blood cholestrol , prevents cell damage in cancer and HIV patients,and also aids in wound healing and growth acceleration.Royal jelly in dentistry has superior anti microbial effect on periodontal pathogens .These beneficial properties are considered and therefore further clinical trial is carried out to evaluate the efficacy of royal jelly-zinc oxide mixture and royal jelly - calcium hydroxide mixture as root canal filling material in the primary molars. |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
Children having no history of systemic illness and previous hospitalization.
Primary molar teeth with irreversible pulpitis and restorable crown structure.
Primary molar teeth with minimal periradicular changes.
Radiographic evidence of teeth showing no signs of active resorption |
|
| ExclusionCriteria |
| Details |
Children with any known allergy .
Special children with physical or emotional alteration.
Children with systemic illness
Grossly decayed teeth with non-restorable crown structure.
Primary molar teeth showing less than two-thirds of remaining root. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To assess clinical and radiographic success of royal jelly-zinc oxide paste as obturation material .
2.To assess clinical and radiographic success of royal jelly-calcium hydroxide paste as obturation material .
3.To assess clinical and radiographic success of Calcium hydroxide - idodoform paste as obturation material |
At 3 Months and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1.To compare and assess the clinical and radiographic success of royal jelly - zinc oxide , royal jelly - calcium hydroxide and calcium hydroxide - iodoform paste as obturation material. |
At 3 and 6 months |
|
|
Target Sample Size
|
Total Sample Size="51"
Sample Size from India="51"
Final Enrollment numbers achieved (Total)= "51"
Final Enrollment numbers achieved (India)="51" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
20/10/2021 |
| Date of Study Completion (India) |
21/01/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="2"
Days="11" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
To aim of this study is to evaluate and compare the clinical and radiographical success of royal jelly - zinc oxide paste, royal jelly - calcium hydroxide paste , as obturation materials with conventional calcium hydroxide-iodoform paste in primary molars .It is a randomised control trial.The sample size is estimated to be 51 with 1:1:1 allocation ratio.The methodology is as follows,Children fulfilling the inclusion and exclusion criteria will be included in the study and randomly allocated to either of the three groups. Pulpectomy treatment is initiated, then the obturating material to be used is selected and the teeth is obturated with either royal jelly - zinc oxide paste , royal jelly - calcium hydroxide paste or calcium hydroxide - iodoform paste.The clinical and radiographic success is assessed using modified Coll and Sadrian criteria at 3 and 6 months.The data obtained will be subjected to statistical analysis and the results are tabulated.
|