A clinical trial to study the pain induced during injection of local anesthesia

Completed

• Conditions: Healthy human volunteers with no systemic disease were selected

• Registration Number: CTRI/2020/12/029561
• Lead Sponsor: Dr Arunajatesan Subbiya MDS

Brief Summary

The aim of the study is to assess and compare the pain during infiltration by a modified two-stage local anaesthetic (LA) infiltration technique under topical anesthesia (TA). Depending upon the infiltration technique, TA and the time gap between TA and infiltration, the patients will be randomly divided into 4 groups. LA will be administered by infiltration at the mucobuccal fold of the maxillary central incisor and the pain perceived during the infiltration in each group will be recorded. The volunteers will be recalled after 24 hrs to assess the tenderness at the injection site.The results will be statistically analyzed.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2020-12-28
• Study Completion: 2020-12-29
• Study Start: 2021-04-01

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Healthy human volunteers -Adult males / females Age : 25 to 40 yrs Sex : Male and female No systemic disease No use of analgesics, sedatives, or anti-anxiety medications for at least 2 weeks before the study Presence of an intact or minimally restored maxillary central incisor No tenderness to percussion and palpation.
• The diagnosis of a clinically normal pulp confirmed by the electric pulp test.

Exclusion Criteria

Pregnancy Presence of systemic disease, medically compromised patients Presence of sensitivity to lidocaine or dibucaine Presence of deep carious lesion involving pulp of maxillary central incisor Tenderness to percussion and palpation present.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Degree of pain during injection in a scale of 0 to 10	1-immediate | 2-after 24 hrs

Secondary Outcome Measures

Name	Time	Method
Degree of pain after 24 hrs of injection in a scale of 0to10	24hrs

Trial Locations

Locations (1)

Sree Balaji Dental college and hospital; 🇮🇳 Chennai, TAMIL NADU, India

Sree Balaji Dental college and hospital

🇮🇳Chennai, TAMIL NADU, India

Dr Arunajatesan Subbiya

Principal investigator

09840197437

drsubbiya@gmail.com