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CTRI Number  CTRI/2025/05/086327 [Registered on: 05/05/2025] Trial Registered Prospectively
Last Modified On: 01/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study comparing how well Articaine and Lignocaine work to numb the upper jaw during dental implant procedures. 
Scientific Title of Study   Efficacy Of 4 percent Articaine Vs 2 percent Lignocaine in achieving anesthesia following infiltration during implant placement in maxilla A randomized controlled 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  Dr Soniya Sawakare 
Designation  1st year MDS PG Student 
Affiliation  K M Shah Dental College And Hospital 
Address  Department no.7, K M Shah Dental College And Hospital, Sumandeep Vidyapeeth, at and post Piparia, taluk Waghodia, Vadodara, Gujarat -391760
Department no.7, K M Shah Dental College And Hospital, Sumandeep Vidyapeeth, at and post Piparia, taluk Waghodia, Vadodara, Gujarat -391760
Vadodara
GUJARAT
391760
India 
Phone  9920369625  
Fax    
Email  soniya132000@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR Monali Shah 
Designation  Professor and Head 
Affiliation  K M Shah Dental College And Hospital 
Address  Department no.7, K M Shah Dental College And Hospital, Sumandeep Vidyapeeth, at and post Piparia, taluk Waghodia, Vadodara, Gujarat -391760
Department no.7, K M Shah Dental College And Hospital, Sumandeep Vidyapeeth, at and post Piparia, taluk Waghodia, Vadodara, Gujarat -391760
Vadodara
GUJARAT
391760
India 
Phone  9824003228  
Fax    
Email  smonali2011@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR MONALI SHAH 
Designation  PROFESSOR AND HEAD  
Affiliation  K M SHAH DENTAL COLLEGE AND HOSPITAL 
Address  DEPARTMENT NO.7, DEPARTMENT OF PERIODONTOLOGY, K M SHAH DENTAL COLLEGE AND HOSPITAL, SUMANDEEP VIDYAPEETH, AT AND POST PIPARIA, TALUK WAGHODIA, VADODARA, GUJARAT -391760
DEPARTMENT NO.7, DEPARTMENT OF PERIODONTOLOGY, K M SHAH DENTAL COLLEGE AND HOSPITAL, SUMANDEEP VIDYAPEETH, AT AND POST PIPARIA, TALUK WAGHODIA, VADODARA, GUJARAT -391760
Vadodara
GUJARAT
391760
India 
Phone  9824003228  
Fax    
Email  smonali2011@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Dr Soniya Sawakare 
Address  Department no.7, K M Shah dental college and hospital, Sumandeep Vidyapeeth, at and post Piparia, taluk Waghodia, Vadodara, Gujarat -391760 
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 
Dr Monali Shah  K M Shah Dental College And Hospital  Department no.7, K M Shah Dental College And Hospital, Sumandeep Vidyapeeth, at and post Piparia, taluk Waghodia, Vadodara, Gujarat -391760
Vadodara
GUJARAT 		 9824003228

smonali2011@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SUMANDEEP VIDYAPEETH INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K081||Complete loss of teeth,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  ARTICAINE  Articaine hydrochloride is an amide local anesthetic, 4-methyl-3 (2 [propylamino] propionamido)-2-thiophenecarboxylic acid, methyl ester hydrochloride. It is unique among amide local anesthetics in that it contains a thiophene group, which increases its liposolubility, and is the only widely used amide local anesthetic that also contains an ester group.Articaine and its metabolites are eliminated through the kidneys. Approximately 5%–10% of articaine is excreted unchanged. articaine has the shortest metabolic half-life (estimated to be 27–42 min).Articaine has the advantages of low toxicity, good local infiltration and high biological safety. Articaine has a higher success rate in dental infiltration anesthesia and reduces the pain of patients.The total duration of the study is 18 months.The follow up of the study will be done at 3rd and 7th day. 
Comparator Agent  LIGNOCINE  Lidocaine, also known as lignocaine, is a local anesthetic of the amino amide type. Lignocaine is an amino amide compound. Its structure consists of a lipophilic aromatic ring connected to an amide group and a hydrophilic amine group. Lignocaine works by blocking voltage-gated sodium channels in neuronal membrane. Lignocaine has a rapid onset of action (2–5 minutes) and an intermediate duration of effect (approximately 1–2 hours, depending on the formulation and site of administration. Lignocaine is metabolized primarily in the liver through enzymatic processes involving the cytochrome P450 system. Its metabolites are excreted via the kidneys. Pain management is a cornerstone of modern dentistry, and lignocaine is a fundamental tool in achieving this goal. Its versatility, efficacy, and safety profile make it the gold standard for dental anesthetics.The total duration of the study is 18 months.The follow up of the study will be done at 3rd and 7th day. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1) Dental implant placement in maxillary arch
2) Single or multiple dental implant surgeries.
3) Signature of informed consent form  
 
ExclusionCriteria 
Details  1. Pregnancy, lactation, and taking contraceptive pills.
2. Oversensitivity or anaphylactic reactions which contraindicate the intervention.
3. Known allergies
4. Orofacial neurological symptoms.
5. Infections at the operation zone.
6. Psychotropic medicine, sedative, or NSAID use which can alter the sense of pain
7. Pathological mental conditions (dementia, psychosis) and lack of cooperation.
8. Advanced surgical necessities (GBR, split crest, vertical regeneration, block graft, etc.)
9. Operations carried out with conscious sedation.
10. Patients who do not want to sign consent. of interest.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
a.Visual Analogue Scale
b.Verbal pain intensity scale
 		 3rd and 7th day
 
 
Secondary Outcome  
Outcome  TimePoints 
1) Evaluate time required for the onset and duration of anesthesia.
2) Pain perception during infiltration and during surgery.
3) Need for second time anesthesia.
4)Amount of solution used [measured in ml]
5)Pain at the injection site (3rd and 7th day) 		 Pain will be evaluated at injection site at 3rd and 7th day. 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   22/05/2025 
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="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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   Numbing medicine is really important for making dental treatments less painful. Lignocaine has been used for a long time to numb the area during dental work, but it has some downsides. Now, a newer medicine called Articaine is becoming more common. Articaine works better in many cases—it numbs the area more effectively and helps reduce pain more than Lignocaine. Because of this, it’s a great option for everyday dental procedures and may become even more useful in future treatments like dental implants. 
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