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CTRI Number  CTRI/2025/08/092581 [Registered on: 07/08/2025] Trial Registered Prospectively
Last Modified On: 26/08/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Crossover Trial 
Public Title of Study   To assess the effectiveness of of two local anesthetic agents, namely articane and lignociane, to provide anesthesia of the dental pulp of hypomineralized second primary molars requiring root canal treatment in 6-9 year old children. 
Scientific Title of Study   Comparative evaluation of the anesthetic efficacy of 4% Articaine versus 2% Lignocaine in root canal therapy of hypomineralized second primary molars: A split-mouth, double-blinded, 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  Olando Kevin Dsouza 
Designation  MDS on Bond service 
Affiliation  Goa Dental College and Hospital 
Address  Department No.4, Department of Pediatric and Preventive Dentistry, Goa Dental College and Hospital, Bambolim-Goa
Department No.4, Department of Pediatric and Preventive Dentistry, Goa Dental College and Hospital, Bambolim-Goa, 403202
North Goa
GOA
403202
India 
Phone  9284796376  
Fax    
Email  olandokevindsouza@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Olando Kevin Dsouza 
Designation  MDS on Bond service 
Affiliation  Goa Dental College and Hospital 
Address  Department No.4, Department of Pediatric and Preventive Dentistry, Goa Dental College and Hospital, Bambolim-Goa
Department No.4, Department of Pediatric and Preventive Dentistry, Goa Dental College and Hospital, Bambolim-Goa

GOA
403202
India 
Phone  9284796376  
Fax    
Email  olandokevindsouza@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Olando Kevin Dsouza 
Designation  MDS on Bond service 
Affiliation  Goa Dental College and Hospital 
Address  Department No.4, Department of Pediatric and Preventive Dentistry, Goa Dental College and Hospital, Bambolim-Goa
Department of Pediatric and Preventive Dentistry, Goa Dental College and Hospital, Bambolim-Goa

GOA
403202
India 
Phone  9284796376  
Fax    
Email  olandokevindsouza@gmail.com  
 
Source of Monetary or Material Support  
Department No.4, Department of Pediatric and Preventive Dentistry, Goa Dental College and Hospital, Bambolim-Goa, India, 403202 
 
Primary Sponsor  
Name  Olando Kevin Dsouza 
Address  Department No.4, Department of Pediatric and Preventive Dentistry, Goa Dental College and Hospital, Bambolim-Goa, India, 403202 
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 Olando Kevin Dsouza  Goa Dental College and Hospital  Department No.4, Department of Pediatric and Preventive Dentistry, Goa Dental College and Hospital, Bambolim-Goa, India, 403202
North Goa
GOA 
9284796376

olandokevindsouza@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Goa Dental College and Hospital Institutional Review Board  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K040||Pulpitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  2% lignocaine in 1:80,000 epinephrine  Maximum dose of 2% lignocaine will be calculated based on the weight of individual patient (maximum 4.4mg/kg). The anesthetic agent will be administered once in the form of an inferior alveolar nerve block. The entire procedure will be completed within one and a half hour. 
Intervention  4% articaine in 1:100,000 epinephrine   Maximum dose of 4% articaine will be calculated based on the weight of individual patient (maximum 7mg/kg). The anesthetic agent will be administered once in the form of an inferior alveolar nerve block. The entire procedure will be completed within one and a half hour.  
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  9.00 Year(s)
Gender  Both 
Details  1. Positive or absolute positive behavior according to Frankl behavior classification (Frankl et al. 1962)
2. Bilateral mandibular hypomineralized second primary molars (diagnostic criteria by Ghanim et al. 2017), with signs of irreversible pulpitis and requiring root canal therapy
3. Children who are not under the effects of analgesics or sedatives
4. Parents will be willing to provide a written informed consent to participate in the study
 
 
ExclusionCriteria 
Details  1. Children with known allergy to the anesthetic agents used
2. Teeth with non-vital pulp
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Anesthetic efficacy of 4% articaine versus 2% lignocaine, when administered as an inferior alveolar nerve block (IANB) for root canal therapy of hypomineralized mandibular second primary molars  1. on injection
2. during access opening
3. during instrumentation 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="20" 
Phase of Trial   N/A 
Date of First Enrollment (India)   25/08/2025 
Date of Study Completion (India) 08/12/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
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  

Developmental defects of enamel (DDE) is currently one of the most prevalent conditions affecting children worldwide. Hypomineralized second primary molar (HSPM) is the current term being used for the condition previously described as deciduous molar hypomineralization. It is a qualitative developmental defect resulting from the disruption of enamel during formation. It usually presents as a clear demarcated opacity in the enamel translucency. This opacity may vary to several degrees from opaque white, yellow, to brown-colored lesion of enamel. Hypomineralized second primary molars have a clinical presentation similar to that of molar incisor hypomineralizaion. This may be due to a shared period of amelogenesis by second primary molars and first permanent molars. This condition is not just a related phenomenon to MIH but presents as a unique predictive factor for the occurrence of MIH. There is a likelihood of HSPMs being associated with post-eruptive breakdown and being more prone to caries. The hypomineralised enamel is a poor insulator and therefore, the pulp is not well protected from external thermal stimuli. As a result, the tooth becomes hypersensitive to hot and cold temperatures. This chronic stress on the pulp leads to an inflammatory response within the pulp and pH changes at periapical tissue level leading to hypersensitive pulp nerve tissue which excite with less stimulation than normally necessary. The clinical implication of this is a hypersensitive tooth that is difficult to anaesthetise even with increasing the local anaesthetic dose. There are several local anesthetics that can be used in children, the most common being: articaine 4% and lignocaine 2%. Although several studies have been published comparing lidocaine 2% to articaine 4% in children, results have been mixed. To date, there is no randomized clinical study comparing lidocaine with articaine when an inferior alveolar nerve block (IANB) is used for local anesthesia of HSPMs.

 
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