| CTRI Number |
CTRI/2025/04/083885 [Registered on: 02/04/2025] Trial Registered Prospectively |
| Last Modified On: |
01/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
how effective is hyaluronidase when used as an adjuvant to lignocaine when used as a local aneshtetic agent |
|
Scientific Title of Study
|
Anesthetic Efficacy of Hyaluronidase as an Adjuvant to Lignocaine-Epinephrine in Maxillary Anterior Extractions: A Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Roshani R. Autade |
| Designation |
Resident Doctor |
| Affiliation |
Government Dental College and Hospital, Jamnagar |
| Address |
Department of Oral and Maxillofacial Surgery, Government Dental College and Hospital, Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
9324808625 |
| Fax |
|
| Email |
rautade15@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Nishit K. Shah |
| Designation |
CONSULTANT TUTOR |
| Affiliation |
Government Dental College and Hospital, Jamnagar, India 361008 |
| Address |
Department of Oral and Maxillofacial Surgery, Government Dental College and Hospital, Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
9324808625 |
| Fax |
|
| Email |
drnishitomfs@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Nishit K. Shah |
| Designation |
CONSULTANT TUTOR |
| Affiliation |
Government Dental College and Hospital, Jamnagar, India 361008 |
| Address |
Department of Oral and Maxillofacial Surgery, Government Dental College and Hospital, Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
9824282509 |
| Fax |
|
| Email |
drnishitomfs@gmail.com |
|
|
Source of Monetary or Material Support
|
| DR. Roshani R. Autade
Department of Oral and Maxillofacial Surgery, Government Dental College and Hospital, Pathikashram Road, Navagam, Ghed, Jamnagar, India 361008 |
|
|
Primary Sponsor
|
| Name |
DR ROSHANI R AUTADE |
| Address |
DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY GOVERNMENT DENTAL COLLEGE AND HOSPITAL, PATHIKASHRAM ROAD, NAVAGAM, GHED, JAMNAGAR, INDIA 361008 |
| Type of Sponsor |
Other [Individual- Dr Roshani R. Autade (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 AUTADE ROSHANI RAVINDRA |
GOVERNMENT DENTAL COLLEGE AND HOSPITAL, JAMNAGAR |
DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY, ROOM NO.144, EXODONTIA DIVISION
Jamnagar
GUJARAT |
09324808625
rautade15@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, M.P. Shah Govt, Medical College and Guru Gobind Singh Hospital, Jamnagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K002||Abnormalities of size and form ofteeth, (2) ICD-10 Condition: K029||Dental caries, unspecified, (3) ICD-10 Condition: K04||Diseases of pulp and periapical tissues, (4) ICD-10 Condition: K040||Pulpitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
lignocaine with adrenaline |
buccal infiltration of lignocaine with adrenaline will be give and its effect on palatal side will be noted. The duration of anesthesia will be for 60-120 minutes |
| Intervention |
lignocaine with hyaluronidase |
When used in conjunction with hyaluronidase, this formulation facilitates the adequate distribution of the anesthetic, thereby ensuring sufficient analgesia and obviating the necessity for a painful palatal infiltration. The duration of the anesthesia will be for around 60-90 minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
patients requiring prophylactic or remedial extraction of maxillary central and lateral incisors |
|
| ExclusionCriteria |
| Details |
2. Patient with co morbidities
3. History of immunosuppressant use within last 6 months
4. Past or ongoing chemotherapy or radiotherapy
5. Patients with altered hemodynamic values.
6. Women who are pregnant, lactating or taking oral contraceptives.
7. Allergy or hypersensitivity to any of the products used in the study.
8. Any pre operative infection or edema
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| pain, local anesthetic effect, time of onset of anesthesia, complications |
immediately after administration of local anesthetic, 30,60,90,120sec and so on. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Time of onset of anesthesia after administration of Local Anesthetic solution, Other complication
Localized / systemic
Immediate /delayed
|
Immediately after administration of anesthesia, after 30 seconds then at 60 seconds ,then 70,80,90,100,110,120 seconds. |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
Final Enrollment numbers achieved (Total)= "140"
Final Enrollment numbers achieved (India)="140" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
19/04/2025 |
| Date of Study Completion (India) |
15/10/2025 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Maxillary anterior tooth extractions are routinely
performed procedures under local anesthesia and account for 13.9% of total
extractions. The efficacy of local anesthesia is paramount to
ensure patient comfort, reduce anxiety, and facilitate a smooth procedure. The
infiltration technique is commonly used for anesthesia, with lignocaine
(lidocaine) being the anesthetic agent of choice in combination with
epinephrine to prolong the anesthetic effect and minimize bleeding. Hyaluronidase is an enzyme that hydrolyses the hyaluronic component of the
intercellular ground substance, hence the viscosity of the tissues is reduced
permitting a wider spread of the local anesthetic solution. The porous bone in the anterior maxilla offers an
ideal medium for the diffusion of local anesthesia from the buccal to the
palatal side of the associated tooth. When used in conjunction with
hyaluronidase, this formulation facilitates the adequate distribution of the
anesthetic, thereby ensuring sufficient analgesia and obviating the necessity
for a painful palatal infiltration. |