| CTRI Number |
CTRI/2019/04/018821 [Registered on: 29/04/2019] Trial Registered Prospectively |
| Last Modified On: |
25/04/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of an upright versus a supine position on the success of pulpal anesthesia when an Inferior alveolar nerve block is administered in teeth with Irreversible Pulpitis. |
|
Scientific Title of Study
|
Anesthetic Efficacy of Supine and Upright
Positions for the Inferior Alveolar Nerve Block in Teeth with Irreversible Pulpitis: A Prospective, Randomized Study
|
| Trial Acronym |
AEIANBIP |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Not applicable |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Tanya Dhawan |
| Designation |
MDS student |
| Affiliation |
SGT dental college |
| Address |
DP-46, Pitampura, Delhi
Room no. 5, Department of conservative and endodontics, SGT dental college. SGT University, Gurgaon 122505, Haryana
South
DELHI
110088
India |
| Phone |
09953967965 |
| Fax |
|
| Email |
tanya.dhawan6@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mandeep S Grewal |
| Designation |
Head of Department, Department of Conservative dentistry and Endodontics |
| Affiliation |
SGT dental college |
| Address |
Grewal Dental Practice,
5804, Ground Floor,
Aster Avenue, DLF IV,
Gurgaon.
Haryana
Room no. 5, Department of conservative and endodontics, SGT dental college. SGT University, Gurgaon 122505, Haryana
Gurgaon
HARYANA
122002
India |
| Phone |
9810805880 |
| Fax |
|
| Email |
drmandeepsgrewal@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Tanya Dhawan |
| Designation |
MDS student |
| Affiliation |
SGT dental college |
| Address |
DP-46, Pitampura, Delhi
Room no. 5, Department of conservative and endodontics, SGT dental college. SGT University, Gurgaon 122505, Haryana
South
DELHI
110088
India |
| Phone |
09953967965 |
| Fax |
|
| Email |
tanya.dhawan6@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Tanya Dhawan |
| Address |
SGT University,Budhera, Gurgaon |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Mandeep S Grewal |
Grewal Dental Practice,
5804, Ground Floor,
Aster Avenue, DLF IV,
Gurgaon, Haryana 122002 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Tanya Dhawan |
SGT University |
Room no. 5, Department of conservative and endodontics, SGT dental college. SGT University, Gurgaon 122505, Haryana
Gurgaon
HARYANA |
09953967965
tanya.dhawan6@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SGT Dental College Institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Irreversible pulpitis |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Articaine |
Inferior alveolar nerve block
1.7 ml
Duration- 15 minutes |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Symptomatic irreversible pulpitis
2. Patients with active pain in a mandibular first or/and second molar,
3. Patients in good health, with no previous history of allergy to any kind of local anesthesia.
4. Prolonged response to cold testing with Endo-frost
5. Absence of any periapical radiolucency on periapical radiographs
6. A vital coronal pulp on access opening.
|
|
| ExclusionCriteria |
| Details |
1. History of significant medical problems,
2. Taken central nervous system depressants or any analgesic medication within 8 hours,
3. Pregnancy
4. Allergy to articaine
5. Unable to give informed consent
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Efficacy of Supine and Upright Positions |
15 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Any difference in male and female results |
1 month |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
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)
|
01/05/2019 |
| 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="1"
Days="30" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a prospective randomized study comparing the efficacy of supine and upright position on the success of pulpal anaesthesia when an Inferior alveolar nerve block is administered in teeth with Irreversible Pulpitis which will be carried out in SGT University, Budhera, Guragaon, Haryana, India. |