| CTRI Number |
CTRI/2023/04/052054 [Registered on: 27/04/2023] Trial Registered Prospectively |
| Last Modified On: |
26/04/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
to evaluate and compare 2% Lidocaine containing adrenaline with and without hyaluronidase in inferior alveolar nerve blocks for patients requiring bilateral
mandibular extractions |
|
Scientific Title of Study
|
Comparative evaluation of efficacy of 2%Lidocaine containing adrenaline with and without hyaluronidase in inferior alveolar nerve blocks for patients requiring bilateral
mandibular extractions |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Piyush Lunkad |
| Designation |
PG department of oral and maxillofacial surgery |
| Affiliation |
Dr. D Y Patil Dental College and Hospital |
| Address |
Department of oral and maxillofacial surgery
Dr D Y Patil Dental College and Hospital
Dr D Y Patil vidyapeeth sant Tukaram nagar pimpri pune
sr no 3 Lunkad complex kamal nagar Vadgaonsheri pune- 411014
Pune
MAHARASHTRA
411018
India |
| Phone |
9822415680 |
| Fax |
|
| Email |
piyush.lunkad12@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sonal Shah |
| Designation |
MDS professor |
| Affiliation |
Dr D Y Patil Dental College and Hospital Dr D Y Patil vidyapeeth sant Tukaram nagar pimpri pune |
| Address |
Department of oral and maxillofacial surgery
Dr D Y Patil Dental College and Hospital
Dr D Y Patil vidyapeeth sant Tukaram nagar pimpri pune
sunflower Sukhani complex Vallabh nagar sant Tukaram nagar pimpri pune -411018
Pune
MAHARASHTRA
411018
India |
| Phone |
9833459822 |
| Fax |
|
| Email |
sonal.shah@dpu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sonal Shah |
| Designation |
MDS professor |
| Affiliation |
Dr D Y Patil Dental College and Hospital Dr D Y Patil vidyapeeth sant Tukaram nagar pimpri pune |
| Address |
Department of oral and maxillofacial surgery
Dr D Y Patil Dental College and Hospital
Dr D Y Patil vidyapeeth sant Tukaram nagar pimpri pune
sunflower Sukhani complex Vallabh nagar sant Tukaram nagar pimpri pune -411018
Pune
MAHARASHTRA
411018
India |
| Phone |
9833459822 |
| Fax |
|
| Email |
sonal.shah@dpu.edu.in |
|
|
Source of Monetary or Material Support
|
| Dr dy patil dental college and hospital |
|
|
Primary Sponsor
|
| Name |
Dr Piyush Lunkad |
| Address |
Dr D Y Patil Dental College and Hospital
Dr D Y Patil vidyapeeth sant Tukaram nagar pimpri pune |
| 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 |
| Dr piyush Lunkad |
Dr D Y Patil Dental College and Hospital |
department of oral and maxillofacial surgery
room no 9
3rd floor
Pune
MAHARASHTRA |
9822415680
piyush.lunkad12@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics sub committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
2 % lidocaine with adrenaline |
2 % lidocaine with 1:200000 adrenaline will be given on side and inferior alveolar nerve block will be given |
| Intervention |
2 % lidocaine with adrenaline with Hyaluronidase
|
Hyaluronidase is available as a 1500 IU amorphous powder, and it will be diluted by adding the whole content of powder to 2 ml normal saline.
Then from 2 ml, 0.1 ml Hyaluronidase (75 IU) will be added to 2 % Lignocaine containing 1:200000 adrenaline (3 ml) and inferior alveolar nerve block will be given
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients who are 18 years and above
Patients requiring bilateral mandibular teeth extraction
Patients who are willing to participate in the study .
|
|
| ExclusionCriteria |
| Details |
Patients with history of systemic disease [ uncontrolled diabetes , uncontrolled
hypertension, radiotherapy and bleeding disorder, mental disorder ]
Patients with any local infection
Patients with pre-operative pain
Patient allergic to local anesthesia
Patients allergic to hyaluronidase
Root pieces with periapical pathology likecyst, tumor etc
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the pain perception |
immediately postoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| pain |
immediate post operative |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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)
|
15/05/2023 |
| 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="6"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
- Local anaesthesia is a medium to control pain during the dental extraction.
- The use of hyaluronidase in local anesthesia is a common practice in ophthalmological surgery.
- When hyaluronidase was incorporated adequate block would be established with smaller volumes of anesthetic solution.
- The role of hyaluronidase is that it increases the diffusablitiy of the local anesthetic through tissues so as to reach it to nerve, therefore when it is used in conjugation with LA solution, it might fasten onset of anesthetic effect.
- By administration of hyaluronidase the interval between completion of block and the establishment of analgesia is markedly reduced.
- The spreading effects appears to be increased by epinephrine
- .In this study we compare and evaluated the efficacy of 2 % lidocaine containing adrenaline with and without hyaluronidase in inferior alveolar nerve blocks for patients requiring bilateral mandibular extractions. We also evaluated the onset, duration and need of any supplementary anaesthesia in both the groups. In this study we compare and evaluated the efficacy of 2 % lidocaine containing adrenaline with and without hyaluronidase in inferior alveolar nerve blocks for patients requiring bilateral mandibular extractions. We also evaluated the onset, duration and need of any supplementary anaesthesia in both the groups.
In this study we compare and evaluated the efficacy of 2 % lidocaine containing adrenaline with and without hyaluronidase in inferior alveolar nerve blocks for patients requiring bilateral mandibular extractions. We also evaluated the onset, duration and need of any supplementary anaesthesia in both the groups. |