| 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
|
|
|
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
|
|
|
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. |