| CTRI Number |
CTRI/2018/04/013463 [Registered on: 24/04/2018] Trial Registered Retrospectively |
| Last Modified On: |
19/04/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
For comparing two injection techniques for treating decayed teeth. |
|
Scientific Title of Study
|
Comparative evaluation of anesthetic efficacy of intraligamentary injection technique and inferior alveolar nerve block for vital pulp therapy in primary mandibular molars : an in vivo study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shriyam Sharan |
| Designation |
Post Graduate student |
| Affiliation |
I T S Dental College, Hospital And Research Centre, Greater Noida |
| Address |
Room number 8 ,Department of Pedodontics and Preventive dentistry, I T S Dental College , Hospital and Research centre .
Greater Noida
47 , Knowledge park 3, Gautam Buddha Nagar,
Greater Noida.
Gautam Buddha Nagar
UTTAR PRADESH
201308
India |
| Phone |
9953965839 |
| Fax |
|
| Email |
ishriyam@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mousumi Goswami |
| Designation |
Head of Department , Pedodontics, ITS Dental College , Greater Noida |
| Affiliation |
ITS Dental College ,Hospital and Research Centre |
| Address |
Room number 8,Department of pedodontics and preventive dentistry, Head of Department Pedodontics, ITS Dental College , Hospital and Research Centre ,
Greater Noida.
Gautam Buddha Nagar
UTTAR PRADESH
201308
India |
| Phone |
8588854190 |
| Fax |
|
| Email |
mousumi_leo@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Shriyam Sharan |
| Designation |
Post Graduate student |
| Affiliation |
|
| Address |
department of pediatric dentistry , room number 8, I T S Dental College , Hospital and Research Centre .
47 , Knowledge Park 3, Gautam Buddha Nagar,
Gautam Buddha Nagar
UTTAR PRADESH
201308
India |
| Phone |
9953965839 |
| Fax |
|
| Email |
ishriyam@gmail.com |
|
|
Source of Monetary or Material Support
|
| 47, knowledege park 3,ITS Dental College Hospital And Research
Centre.
Greater Noida |
|
|
Primary Sponsor
|
| Name |
Shriyam Sharan |
| Address |
I T S Dental College , Hospital and Research Centre , Knowledge Park 3 Greater Noida. 201308
47 , knowledge park 3, gautam buddha nagar, |
| Type of Sponsor |
Other [] |
|
|
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 |
| Shriyam Sharan |
I T S Dental College , Hospital and Research centre , Greater Noida. |
Room number 8, Department of Pedodontics and Preventive dentistry,I T S Dental College , Hospital and Research centre .
47 , Knowledge park 3, Gautam Buddha Nagar,
Greater Noida.
Gautam Buddha Nagar
UTTAR PRADESH |
9953965839
ishriyam@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| I.T.S INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
patients requiring vital pulp therapy bilaterally in mandibular primary molars., |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Intraligamentary injection and inferior alveolar nerve block technique |
Anesthetic efficacy of two deffirent injection technique.
Intraligamentary injection and inferior alveolar nerve block technique for vital pulp therapy in primary mandibular molar. |
| Intervention |
Intraligamentary injection and inferior alveolar nerve block technique. |
Anesthetic efficacy of Intraligamentary injection and inferior alveolar nerve block technique for vital pulp therapy in primary molars.
|
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
• Healthy children between the age of 4-10 years.
• Children requiring vital pulp therapy in primary mandibular molars.
• At least 2/3rd of the root length is available
• Minimal periapical changes with sufficient bone support .
• Internal resorption without any obvious perforation
|
|
| ExclusionCriteria |
| Details |
1.Patient suffering from any medical or Systemic conditions.
2.Excessive mobility of teeth
3.Non restorable tooth.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Anesthetic efficacy between inferior alveolar nerve block and intraligamentary injection technique.
2.pain perception during vital pulp therapy. |
24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) pain during administration of anesthesia.
2) pain while performing vital pulp therapy. |
1-2 hours |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/03/2017 |
| 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="4"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
not yet. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a randomized control trial to compare and evaluate anesthetic efficacy of intraligamentary injection technique
and Inferior Alveolar nerve block for vital pulp therapy in primary mandibular
molars . In which we will select 30 children who requires vital pulp therapy biltaerally in primary mandibular molars, between the group of 4- 10 years.They will be randomly divided between two groups receiving each injection technique and pain parameters and anxiety scale of children will be assessed during the treatment. |