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CTRI Number  CTRI/2020/04/024468 [Registered on: 03/04/2020] Trial Registered Prospectively
Last Modified On: 03/04/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia
Dentistry 
Study Design  Other 
Public Title of Study   A comparative study to evaluate the effect of dexmedetomidine in 2% lignocaine hydrochloride vs adrenaline in 2% lignocaine hydrochloride for extraction of maxillary molars by the infiltration technique.” 
Scientific Title of Study   A comparative study to evaluate the effect of 30 mcg dexmedetomidine in 2% lignocaine hydrochloride vs 1:80,000 adrenaline in 2% lignocaine hydrochloride for extraction of maxillary molars by the infiltration technique.” 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Apurva Vaidya 
Designation  3rd yr MDS 
Affiliation  Terna dental college 
Address  A 603 sky avenue building opp bank of india kamothe sec 34 navi mumbai
Terna dental college opp nerul west railways station sec 22 Nerul
Mumbai (Suburban)
MAHARASHTRA
410209
India 
Phone  8767755863  
Fax    
Email  apurva.vaidya0@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Sanjay joshi 
Designation  Head of the department 
Affiliation  Terna dental college 
Address  Terna dental college opp nerul west railways nerul sec 22
Terna dental college opp nerul west railways station nerul sec 22
Mumbai (Suburban)
MAHARASHTRA
400706
India 
Phone  9869057337  
Fax    
Email  Sanjoshi99@gmail.com  
 
Details of Contact Person
Public Query  
Name  Apurva Vaidya 
Designation  3rd yr MDS 
Affiliation  Terna dental college 
Address  A 603 sky avenue building opp bank of india kamothe sec 34 navi mumbai
33 nirman nagar tadoba road tukum 1 chandrapur
Chandrapur
MAHARASHTRA
410209
India 
Phone  8767755863  
Fax    
Email  apurva.vaidya0@gmail.com  
 
Source of Monetary or Material Support  
self 
 
Primary Sponsor  
Name  Self funding 
Address  a 603 sky avenue building sec 34 kamothe navi mumbai 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Apurva Vaidya   Terna dental college  Terna dental college opp nerul west railways station sec 22 nerul
Thane
MAHARASHTRA 		 08767755863

apurva.vaidya0@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
terna dental college ethical committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: K029||Dental caries, unspecified, (2) ICD-10 Condition: K029||Dental caries, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Adrenaline with lignocaine  Group B A 2mL solution of 1:80000 adrenaline with 2% lignocaine hydrochloride for the extraction of in maxillary molars using infiltration technique  
Intervention  Dexmedetomidine with lignocaine  Group A A 2mL 30 μg of dexmedetomidine with 2% lignocaine hydrochloride for the extraction of maxillary molars using infiltration techniqu. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients willing to participate in the study
This study will included patients between 18-60yr
Teeth diagnosed with dental caries, teeth which could not be restored and patients who refused conservative management will be included in the study.
patients requiring bilateral orthodontic extraction.

 
 
ExclusionCriteria 
Details  Patients with complains of morbidities such as
hypertension, diabetes mellitus, asthma, bleeding disorders.
Patient who have known allergies to any drug under study.
Pregnant women, nursing mothers and apprehensive patients will be excluded from the study.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Hemodynamic parameters among the both group An observer will be monitored all the patient for Heart Rate (HR) Systolic Blood Pressure (SBP)Diastolic Blood Pressure (DBP)Mean Arterial Pressure (MAP).
 
Hemodynamic parameters among the both group An observer will be monitored all the patient for Heart Rate (HR) Systolic Blood Pressure (SBP)Diastolic Blood Pressure (DBP)Mean Arterial Pressure (MAP).
 
 
Secondary Outcome  
Outcome  TimePoints 
Intensity of anesthesia
Duration of anesthesia  		 no aplicable 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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)   15/04/2020 
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="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Local anesthetic with an optimal duration of action, good analgesia, and negligible toxicity is an optimal choice for removal of tooth   Local anaesthetics alone are less profound and suffer the limitation of a short duration of action as compared to local anaesthetics with adjuvant. The adjuvant are co–administered with the local anaesthetic agents to improve the onset and/or duration of analgesia which include both opioids and non-opioids, including epinephrine and an α2 agonist. . A common standard option is Lignocaine hydrochloride 2% with Adrenaline (1:80,000).Adrenaline is one of the most commonly used adjuvant with lidocaine or any other anaesthetic agent. The predominant action of epinephrine is on β receptors; however, it also affects α receptors. Although potency of ADRENALINE containing dental local anaesthesia is clearly demonstrated to be superior to a plain anaesthetic solution i.e. Without a vasoconstrictor.

 
Nevertheless plain local anaesthetics still preferred for patients with co morbidities like circulatory disorder to avoid complications and adverse systemic effects of vasoconstrictors.Continued search of an ideal adjuvant led the researchers to use a newer member of alpha agonist family “dexmedetomidine”.Dexmedetomidine has been proved in literature as 1620 times selective for alpha 2 receptors and moreover is associated with stable hemodynamics when compared to other adjutants. The drug acts by binding to the presynaptic α-adrenoreceptors which results in the inhibition of release of epinephrine leading to termination of propagation of pain signals. However research studies have only recently focused on this newer drug for its use as a possible additive for local anaesthesia.
objective:-

. Effects of dexmedetomidine (30 μg)  with 2% lignocaine hydrochloride in maxillary infiltration anesthesia for the extraction of maxillary molar teeth.

2. Effects of adrenaline (1:80,000) with 2% lignocaine hydrochloride in maxillary infiltration anesthesia for the extraction of maxillary molar teeth

3. Compare effects of dexmedetomidine (30 μg) with 2% lignocaine hydrochloride versus adrenaline (1:80,000) with 2% lignocaine hydrochloride in maxillary infiltration anesthesia for the extraction of maxillary molar teeth.


 
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