| CTRI Number |
CTRI/2020/12/029561 [Registered on: 04/12/2020] Trial Registered Prospectively |
| Last Modified On: |
28/12/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Diagnostic
Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the pain induced during injection of local anesthesia |
|
Scientific Title of Study
|
Evaluation of the effect of topical anaesthesia and a modified infiltration technique on pain during injection- A double blind clinical trial |
| Trial Acronym |
TAMIT |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Arunajatesan Subbiya MDS |
| Designation |
Professor and Head |
| Affiliation |
Sree Balaji Dental college & Hospital |
| Address |
Dept of Conservative Dentistry and Endodontics
Sree Balaji Dental college & Hospital
Velachery Main Road
Narayanapuram
Pallikaranai
Chennai
Velachery Main Road Narayanapuram Pallikaranai
Chennai-600100
Chennai
TAMIL NADU
600100
India |
| Phone |
09840197437 |
| Fax |
|
| Email |
drsubbiya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arunajatesan Subbiya MDS |
| Designation |
Professor and Head |
| Affiliation |
Sree Balaji Dental college & Hospital |
| Address |
Dept of Conservative Dentistry and Endodontics
Sree Balaji Dental college & Hospital
Velachery Main Road
Narayanapuram
Pallikaranai
Chennai
Velachery Main Road Narayanapuram Pallikaranai
Chennai-600100
Chennai
TAMIL NADU
600100
India |
| Phone |
09840197437 |
| Fax |
|
| Email |
drsubbiya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arunajatesan Subbiya MDS |
| Designation |
Professor and Head |
| Affiliation |
Sree Balaji Dental college & Hospital |
| Address |
Dept of Conservative Dentistry and Endodontics
Sree Balaji Dental college & Hospital
Velachery Main Road
Narayanapuram
Pallikaranai
Chennai
Velachery Main Road Narayanapuram Pallikaranai
Chennai-600100
Chennai
TAMIL NADU
600100
India |
| Phone |
09840197437 |
| Fax |
|
| Email |
drsubbiya@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sree Balaji Dental College
Pallikaranai, Chennai 600100 |
|
|
Primary Sponsor
|
| Name |
Dr Arunajatesan Subbiya MDS |
| Address |
Dept of Conservative Dentistry and Endodontics
Sree Balaji Dental college & Hospital
Pallikaranai
chennai |
| Type of Sponsor |
Other [Principal Investigator] |
|
|
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 |
| Dr Arunajatesan Subbiya |
Sree Balaji Dental college and hospital |
Velachery Main road
Narayanapuram
Pallikaranai
chennai-600100
Chennai
TAMIL NADU |
09840197437
drsubbiya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional ethics committee (Sree Balaji Dental College and Hospital) Chennai (Reg No. ECR/761/Inst/TN/2015/RR-18 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy human volunteers with no systemic disease were selected |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo gel |
water based gel
|
| Intervention |
Precaine gel |
Precaine gel (Lidocaine 8%, Dibucaine 0.8%) (Pascal Co Inc, Bellevue, WA, USA) |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Healthy human volunteers -Adult males / females
Age : 25 to 40 yrs
Sex : Male and female
No systemic disease
No use of analgesics, sedatives, or anti-anxiety medications for at least 2 weeks before the study
Presence of an intact or minimally restored maxillary central incisor
No tenderness to percussion and palpation.
The diagnosis of a clinically normal pulp confirmed by the electric pulp test.
|
|
| ExclusionCriteria |
| Details |
Pregnancy
Presence of systemic disease, medically compromised patients
Presence of sensitivity to lidocaine or dibucaine
Presence of deep carious lesion involving pulp of maxillary central incisor
Tenderness to percussion and palpation present
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Degree of pain during injection in a scale of 0 to 10 |
1-immediate
2-after 24 hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Degree of pain after 24 hrs of injection in a scale of 0to10 |
24hrs |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
04/01/2021 |
| Date of Study Completion (India) |
29/12/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
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)?
|
|
Brief Summary
|
The aim of the study is to assess and compare the pain during infiltration by a modified two-stage local anaesthetic (LA) infiltration technique under topical anesthesia (TA). Depending upon the infiltration technique, TA and the time gap between TA and infiltration, the patients will be randomly divided into 4 groups. LA will be administered by infiltration at the mucobuccal fold of the maxillary central incisor and the pain perceived during the infiltration in each group will be recorded. The volunteers will be recalled after 24 hrs to assess the tenderness at the injection site.The results will be statistically analyzed. |