Evaluation of clinical effectiveness of buffered and nonbuffered 4% articaine infiltration for primary maxillary molar extraction.

Not yet recruiting

• Conditions: Healthy children of 4-10 years of age.Children Having at least one primary maxillary molar indicated for extractionunder local anaesthetic.; Dental root caries, (2) ICD-10 Condition: K027||Dental root caries,

• Registration Number: CTRI/2022/01/039457
• Lead Sponsor: Dr Parag Sadashiv Dhake

Brief Summary

The effective control of pain during dental procedures is an important prerequisite of paediatric dentistry. Though local anaesthetic injections trigger pain and anxiety in children, they continue to be used in dental treatment for children’s comfort, cooperation and pain-free treatment.

Articaine is considered a unique local anaesthetic agent and buccal infiltration with articaine can be used to anaesthetize dental tissues for various dental procedures.



Adrenaline is important in local anaesthetic as it prolong the anaesthetic effect. Lower pH of local anaesthetic solution is set for increasing shelf life of adrenaline. Buffered local anaesthetic have been reported to improve anaesthetic onset and success. Systematic review in medicine have shown reduced injection pain with buffered anaesthetics.



Buffering has been reported to enhance the depth and duration of the anaesthetic level without causing untoward effects on the haemostatic properties of adrenaline when it is added to the solution.



The buffering of lidocaine has been widely evaluated in field of medicine. Though lidocaine is gold standard in local anaesthesia, studies have reported articaine to be more or equally effective when compared to lidocaine in infiltration anaesthesia.



The purpose of this study is to evaluate effectiveness of buffered articaine for primary maxillary molar extractions and pain on injection in children.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2022-01-14
• Study Start: 2022-01-17

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Children Having at least one primary maxillary molar indicated for extraction under local anaesthetic.
• Children who exhibited Frankl’s behavior rating grade three or four i.e positive and definitely positive.

Exclusion Criteria

• Children with active infection at the site of injection.
• Children with known history of allergy to any local anaesthetic agent.
• History of major dental treatment in last 6 months.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate clinical effectiveness of buffered and nonbuffered 4% articaine (with adrenaline	After infiltration anaesthesia
1:100000) infiltration for primary maxillary molar extractions	After infiltration anaesthesia

Secondary Outcome Measures

Name	Time	Method
To compare and evaluate pain on injection of buffered and nonbuffered 4% articaine (with adrenaline 1:100000) infiltration for primary maxillary molar extractions.	During infiltration anaesthesia

Trial Locations

Locations (1)

V.S.P.M. Dental college and Research Centre, Nagpur; 🇮🇳 Nagpur, MAHARASHTRA, India

V.S.P.M. Dental college and Research Centre, Nagpur

🇮🇳Nagpur, MAHARASHTRA, India

Dr Parag Sadashiv Dhake

Principal investigator

9403410920

dhakeparag6@gmail.com