MedPath

To assess the feeling of pain on injection of softened and preheated local anesthetic solution for the children who are undergoing baby (milk teeth) root canal treatment

Phase 2
Not yet recruiting
Conditions
Dental caries,
Registration Number
CTRI/2025/06/089124
Lead Sponsor
Dr sowmiya M
Brief Summary

Group 1: prewarmed vs conventional local anesthetic solution; Group 2: buffered vs conventional local anesthetic solution; Group 3: prewarmed vs buffered local anesthetic solution; A split mouth randomized control trial will be conducted on 120 children, 5 to 12 years of age requiring pulp therapy bilaterally on primary mandibular molars. The participants are selected from the patient reporting to the department of paediatric and preventive dentistry. The study will be carried out with the help of two  investigators. The first investigator will select the patient and the selected patient will be randomly divided into 3 equal groups (Group 1, 2, 3) having 40 patients in each group. Randomization will be done using lottery method and the child will be recruited for the study. Once the group was selected, the site for precooling the injection site and for the administration of local anesthetic solution will be selected randomly by coin toss method. This would determine which technique should be administered on first appointment. The alternate technique will be administered during second appointment. The second investigator will assess the anesthetic efficacy, pain during injection and pulp therapy

Detailed Description

Not available

Recruitment & Eligibility

Status
Not Yet Recruiting
Sex
All
Target Recruitment
120
Inclusion Criteria
  • Patient diagnosed with symptomatic irreversible pulpitis in primary mandibular first or second molar bilaterally.
  • Patient between the age group of 5-12 years.
  • Frankel behaviour rating scale : positive and definitely positive.
  • No previous history of receiving dental injections.
Exclusion Criteria
  • Children with history of medically compromising conditions.
  • Medical history suggestive of known or suspected allergies to lignocaine.
  • Patient who had taken analgesics within 24hour preceding the commencement of the endodontic procedure.
  • Any abscess or swelling involving the tooth.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Injecting pre warmed or buffered local anesthetic solution on precooled injection site (less pain perception) can be a better alternative to conventional local anesthetic techniqueAt the time of injection
Secondary Outcome Measures
NameTimeMethod
early onset of pre warmed or buffered local anesthetic solution on precooled injection site & it can be a better alternative to conventional local anesthetic technique.after 2 to 3 minutes of injection

Trial Locations

Locations (1)

Karpaga Vinayaga Institute of Dental Sciences

🇮🇳

Kancheepuram, TAMIL NADU, India

Karpaga Vinayaga Institute of Dental Sciences
🇮🇳Kancheepuram, TAMIL NADU, India
Dr sowmiya M
Principal investigator
6381507301
ish152847@gmail.com

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