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Clinical Trials/CTRI/2025/08/092581
CTRI/2025/08/092581CompletedNot Applicable

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

Olando Kevin Dsouza1 site in 1 country20 target enrollmentStarted: August 25, 2025Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
20
Locations
1
Primary Endpoint
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

Study Overview

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 ofamelogenesis by second primary molars and first permanentmolars. This condition is not just a relatedphenomenon to MIH but presents as a unique predictive factorfor theoccurrence 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Participant, Investigator and Outcome Assessor Blinded

Eligibility Criteria

Ages
6.00 Year(s) to 9.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Positive or absolute positive behavior according to Frankl behavior classification (Frankl et al.
  • Bilateral mandibular hypomineralized second primary molars (diagnostic criteria by Ghanim et al.
  • , with signs of irreversible pulpitis and requiring root canal therapy
  • Children who are not under the effects of analgesics or sedatives
  • Parents will be willing to provide a written informed consent to participate in the study.

Exclusion Criteria

  • Children with known allergy to the anesthetic agents used
  • Teeth with non-vital pulp.

Outcomes

Primary Outcomes

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

Time Frame: 1. on injection | 2. during access opening | 3. during instrumentation

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Olando Kevin Dsouza
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Olando Kevin Dsouza

Goa Dental College and Hospital

Study Sites (1)

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