| CTRI Number |
CTRI/2024/04/065074 [Registered on: 02/04/2024] Trial Registered Prospectively |
| Last Modified On: |
01/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of Anesthetic Efficacy Using Needleless Pressure Injection Technique and Conventional Injection Technique for Dental Extraction Using Infiltration with 2% Lignocaine and 1:2,00,000 Adrenaline: A Randomized Controlled Clinical Study |
|
Scientific Title of Study
|
Comparative Evaluation of Anesthetic Efficacy Using Needleless Pressure
Injection Technique and Conventional Injection Technique for Dental Extraction
Using Infiltration with 2% Lignocaine and 1:2,00,000 Adrenaline: A Randomized
Controlled Clinical Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Arfath Shaikh |
| Designation |
postgraduate student 2nd year |
| Affiliation |
MGM Dental College and Hospital, navi mumbai |
| Address |
MGM dental college and hospital navi mumbai , 410209, oral and maxillofacual department , 4th floor
Raigarh
MAHARASHTRA
410206
India |
| Phone |
9930992527 |
| Fax |
|
| Email |
arfathshaikh96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
dr Adil gandevivala |
| Designation |
Reader |
| Affiliation |
MGM dental college and hospital |
| Address |
MGM dental college and hospital, kamothe, sion-panvel highway navimumbai-410209
department of oral and maxillofacial surgery , 4th floor
Raigarh
MAHARASHTRA
410209
India |
| Phone |
9096815606 |
| Fax |
|
| Email |
dr.adilg@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
dr Adil gandevivala |
| Designation |
Post Graduate Student |
| Affiliation |
MGM dental college and hospital |
| Address |
MGM dental college and hospital, kamothe, sion-panvel highway navimumbai-410209
department of maxillofacial surgery , 4th floor
Raigarh
MAHARASHTRA
410209
India |
| Phone |
9096815606 |
| Fax |
|
| Email |
arfathshaikh96@gmail.com |
|
|
Source of Monetary or Material Support
|
| MGM DENTAL COLLEGE AND HOSPITAL , DEPARTEMNET OF ORAL AND MAXILLOFACIAL SURGERY |
|
|
Primary Sponsor
|
| Name |
MGM dental college and hospital |
| Address |
MGM Dental College and Hospital , Kamothe, Navi Mumbai |
| Type of Sponsor |
Other [self funded] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| self |
MGM Dental college and hospital , navimumbai |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Arfath |
MGM DENTAL COLLEGE AND HOSPITAL |
DEPARTMENT OF ORAL SURGERY 4TH FLOOR ,MGM DENTAL COLLEGE AND HOSPITAL KAMOTHE , NAVIMUMBAI 410209
Raigarh
MAHARASHTRA |
9930992527
arfathshaikh96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE IF MGM DENTAL COLLEGE AND HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K029||Dental caries, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
CONVENTIONAL NEEDLEINJECTION |
CONVENTIONAL NEEDLE INJECTION IS ROUTINE USE METHOD FOR INFILTRATION FOR EXTRACTION |
| Intervention |
NEEDLESS PRESSURE INJECTION |
Needle-free jet injection delivers local anesthetic as a high-speed stream and it is considered a promising way to possibly overcome needle-phobia and dental anxiety. The high-speed stream is formed by pressurizing the fluid which is typically done by releasing a compressed spring
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients in the age group 18-60 years.
Both Male and Female patients.
Patients indicated for extractions of single tooth which can be extracted using infiltration technique
|
|
| ExclusionCriteria |
| Details |
Patients with known allergy to amide type of local anesthetic agent Patients having active local infections, abscess or any other lesion at the injection site.
Patients with systemic co-morbidities that would preclude administration of local anesthesia or adrenaline (eg- disorders of liver, kidney, cardiovascular system, etc.) or are contraindication of extraction. Patients taking medications such as anticoagulant
Alcohol consumption 48 hours before of study.
Patients not willing to participate in the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate and compare the Anesthetic efficacy using needleless
pressure injection technique and conventional injection technique
during dental extraction using infiltration with 2% Lignocaine and
1:2,00,000 Adrenaline |
Immediate after 7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate & compare the Anesthetic efficacy using needleless
pressure injection technique & conventional injection technique
during dental extraction using infiltration with 2% Lignocaine and
1:2,00,000 Adrenaline |
Immediate after 7 days |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
20/04/2024 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
To evaluate and compare the Anesthetic efficacy using needleless pressure injection technique and conventional injection technique during dental extraction using infiltration with 2% Lignocaine and 1:2,00,000 Adrenaline and to evaluate and compare difference in pain felt during delivery of local anesthetic agent, Volume of Local anesthetic drug required, Local Complication using needleless pressure injection technique and conventional injection technique for dental extraction using infiltration with 2% Lignocaine and 1:2,00,000 Adrenaline |