| CTRI Number |
CTRI/2019/05/019329 [Registered on: 24/05/2019] Trial Registered Prospectively |
| Last Modified On: |
20/05/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
TO COMPARE THE EFFECTIVENESS OF CLONIDINE WITH LIGNOCAINE
VERSUS ADRENALINE WITH LIGNOCAINE USED AS LOCAL ANAESTHESIA FOR DENTAL EXTRACTION |
|
Scientific Title of Study
|
COMPARATIVE EFFECTIVENESS OF CLONIDINE WITH LIGNOCAINE
VERSUS ADRENALINE WITH LIGNOCAINE IN MAXILLARY INFILTRATION
ANESTHESIA FOR DENTAL EXTRACTION. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR AVADHUT TUKARAM PHAD |
| Designation |
1st Year MDS Student In Dept. of Oral and Maxillofacial Surgery |
| Affiliation |
TERNA DENTAL COLLEGE |
| Address |
TERNA DENTAL COLLEGE PLOT NO. 12 SECTOR 22, OPP NERUL WEST RAILWAY STATION, NERUL WEST, NAVI MUMBAI
12 SECTOR 22, OPP NERUL WEST RAILWAY STATION, NERUL WEST, NAVI MUMBAI
Mumbai
MAHARASHTRA
400706
India |
| Phone |
9403866402 |
| Fax |
|
| Email |
avdhut.phad@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR VIKRAM KARANDE |
| Designation |
Reader and Guide In Dept. of Oral and Maxillofacial Surgery |
| Affiliation |
TERNA DENTAL COLLEGE |
| Address |
TERNA DENTAL COLLEGE PLOT NO. 12 SECTOR 22, OPP NERUL WEST RAILWAY STATION, NERUL WEST, NAVI MUMBAI
12 SECTOR 22, OPP NERUL WEST RAILWAY STATION, NERUL WEST, NAVI MUMBAI
Mumbai
MAHARASHTRA
400706
India |
| Phone |
9892425481 |
| Fax |
|
| Email |
drvikramkarande@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR AVADHUT TUKARAM PHAD |
| Designation |
1st Year MDS Student In Dept. of Oral and Maxillofacial Surgery |
| Affiliation |
TERNA DENTAL COLLEGE |
| Address |
TERNA DENTAL COLLEGE PLOT NO. 12 SECTOR 22, OPP NERUL WEST RAILWAY STATION, NERUL WEST, NAVI MUMBAI
12 SECTOR 22, OPP NERUL WEST RAILWAY STATION, NERUL WEST, NAVI MUMBAI
Mumbai
MAHARASHTRA
400706
India |
| Phone |
9403866402 |
| Fax |
|
| Email |
avdhut.phad@gmail.com |
|
|
Source of Monetary or Material Support
|
| dr.avadhut phad,sector 18A,beside daily needs,first floor of dr.attardes clinic,nerul west,navi mumbai |
|
|
Primary Sponsor
|
| Name |
Dr Avadhut Phad |
| Address |
Terna Dental College, 12 SECTOR 22, OPP NERUL WEST RAILWAY STATION, NERUL WEST, NAVI MUMBAI |
| Type of Sponsor |
Other [PG Student] |
|
|
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 Avadhut Phad |
Terna Dental College |
1st Floor, Department of Oral And Maxillofaclial Surgery, 12 SECTOR 22, OPP NERUL WEST RAILWAY STATION, NERUL WEST, NAVI MUMBAI
Mumbai
MAHARASHTRA |
9403866402
avdhut.phad@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutionalethicalcommittee |
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 |
| Intervention |
CLONIDINE WITH LIGNOCAINE |
Maxillary infiltration anesthesia will be carried out by using 1.5ml containing 15 μg/ml of clonidine with 2% lignocaine hydrochloride |
| Comparator Agent |
Adrenaline with Lignocaine |
Maxillary infiltration anesthesia will be carried out using 1.5ml containing 1:80,000 adrenaline with 2% Lignocaine hydrochloride |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. This study will included patients between 18-60yr, 2. Teeth diagnosed with dental caries, teeth which could not be restored and patients who refused conservative management will be included in the study. 3. Patients requiring bilateral orthodontic extraction. 4. Patients willing to participate in the study. |
|
| ExclusionCriteria |
| Details |
1. Patients with complains of morbidities such as hypertension, diabetes mellitus, asthma, bleeding disorders.
2. Patient who have known allergies to any drug under study,
3. Pregnant women, nursing mothers and apprehensive patients will be excluded from the study.
4. Patients with impacted teeth will be excluded from the study.
5. Patients with the oro-facial space infection will be excluded from the study. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Onset of anesthesia Intensity of anesthesia
Hemodynamic parameters among the both groups: An observer, will be monitored all the patient for
Heart Rate (HR),
Systolic Blood Pressure (SBP)
Diastolic Blood Pressure (DBP).
Mean Arterial Pressure (MAP). |
1.The onset of anesthesia will be investigated by probing with Moons probe every 30 sec. after withdrawal of needle until the probing does not induce pain sensation.
2.Hemodynamic parameters will be continuously monitored in all patients to record heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure will be taken during administration of local anesthesia, 5 min after administration of anesthesia, during surgery and 10 min following completion of surgery.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Age & gender distribution:
Onset of anesthesia
Intensity of anesthesia
|
Additional recordings will be made during
Administration of local anesthesia,
During the procedure,
5 min after administration of anesthesia,
10 min following completion of the procedure
|
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
03/06/2019 |
| 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="1"
Months="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The aim of the present clinical study is to evaluate whether an admixture of clonidine plus 2% lignocaine is an effective alternative to the epinephrine plus 2% lignocaine mixture in terms of Onset of anesthesia, Intensity of anesthesia, hemodynamic response, in patients undergoing bilateral removal of maxillary posterior teeth using maxillary infiltration anesthesia. Study Design: Split mouth double blind study. • Study setting: This study will be conducted in the Department of Oral & Maxillofacial Surgery. • Study Population: 30 Healthy patients aged between 18-60 years requiring removal of bilateral maxillary posterior teeth reporting to department of oral & maxillofacial surgery will be included in the study. • Sampling Technique: Convenience sampling. • Selected patient will be divided into two groups and Extractions will be done in two different appointments . The parameters to be evaluated for the study include: • Age & gender distribution: • Onset of anesthesia • Intensity of anesthesia • Hemodynamic parameters among the both groups: An observer, will be monitored all the patient for o Heart Rate (HR), o Systolic Blood Pressure (SBP) o Diastolic Blood Pressure (DBP). o Mean Arterial Pressure (MAP). • Initial measurements will be obtained prior to anesthesia. • Additional recordings will be made during • Administration of local anesthesia, • During the procedure, • 5 min after administration of anesthesia, • 10 min following completion of the procedure. |