Comparison of time at which the patient starts feeling the numbness and its duration and quality after local anesthesia injection using computerised injection system

Phase 4

Completed

• Conditions: Contralateral vital permanent mandibular molars with asymptomatic apical periodontitis; Bilateral mandibular molars with asymptomatic apical periodontitis

• Registration Number: CTRI/2018/04/013077
• Lead Sponsor: Dr Neha Deshpande

Brief Summary

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|The proposed study will be forwarded to Institutional Ethical Committee for its clearance.

100 adult patients in the age group of 20-45 years willing to participate in the study will be selected by simple random sampling from the Out Patient Department(OPD) at the Department of Conservative Dentistry and Endodontics, Sinhgad Dental college and hospital, Pune. Informed consent will be obtained from each patient.

100 patients in the age group of 20-45 years requiring local anesthesia for endodontic therapy in the mandibular molars with asymptomatic apical periodontitis with asymtomatic pulpitis would be selected

Mandibular molars with asymtomatic apical periodontitis and asymtomatic pulpitis,  radiographically showing intact lamina dura with widening of periodontal ligament space

The patients would be asked to pick up a chit to decide the local anesthesia delivery system to be used in the 1st appointment

Intervention 1 : Inferior alveolar nerve block would be  administered on one side of the arch using 4% Articaine with 1:100,000 epinephrine  with a 27 gauge 11/2 inch needle with the local anesthesia delivery technique according to the chit taken out by the patient, after a 60-seconds application of topical anesthetic gel (5% Lidocaine gel)

Enrolled patients would receive 1.7 mL 4%Articaine with 1:100,000 epinephrine (Septanest, Septodont,France)

All the injections would be given by the same operator and the second operator would note the readings like lip numbness, pain during injection, during access cavity preparation or the instrumentation procedure till the completion of endodontic treatment

Rate of delivery/ Speed of injection :

•         For conventional technique : 1ml/minute

•         For Computer-controlled anesthesia : 1ml/minute

The endodontic treatment would be completed and any pain during the procedure would be noted

Intervention 2 : After 1 week from the 1st appointment, inferior alveolar nerve block would be  administered on the other side of the arch in a similar way using the second local anesthesia delivery technique and endodontic procedure completed

Onset of actionof the local anesthetic would be determined by asking the patient to report the start of lip numbness or tingling sensation

Absence of pain during access preparation or instrumentation  would be considered as anesthesia success

Pain at any point of the endodontic procedure is considered as anesthetic failure

If there is pain during endodontic procedure , a buccal infiltration or a second inferior alveolar nerve block would be administered

Duration of actionof local anesthetic would be determined by asking the patient to record the time after which he/she stops feeling the numbness

  1.     Injection by Conventional anesthetic technique: The inferior alveolar nerve block will be administered for one side mandibular molar with a 27-gauge, long (11/2 inch) needle.

2.     Injection by the CCLAD : No Pain III would be the equipment used for computer controlled local anesthesia delivery. The equipment comprises of disposable handpiece component and a computer control unit. Handpiece is an ultra-light pen like handle, which is linked to an anesthetic cartridge, with a plastic micro-tubing. Procedure would be followed as per the manufacturer’s instructions. The delivery of local anesthesia will be done under cruze control mode of the equipment at slow speed, regulated, by a pedal/foot control.

Detailed Description

Not available

Study Timeline

• Study Completion: 2018-03-10
• Study Start: 2018-04-16
• Last Update Posted: 2018-12-12

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patients willing to participate in the study Age group : 20.
• 45 years Patients who require local anesthetic injections on at least 2 occassions on bilateral mandibular molars for endodontic procedures Mandibular permanent molars, with fully formed roots (confirmed by periapical radiograph) with asymptomatic apical periodontitis and asymptomatic pulpitis Pulp tests: Delayed response with Electric pulp tester(EPT) Radiograph : Widening of PDL space with intact lamina dura Patients would not have undergone any previous dental local anesthetic experience, in order to be not influenced by a positive or a negative memory Patient would not have taken any medication for the past 2 weeks.

Exclusion Criteria

Patients not willing to participate in the study Pregnant patients History of allergy to the components of the local anesthetic solutions Patients who received local anesthesia before the experiment Subjects with systemic diseases Patients on any kind of medication Patients with psychiatric illness Unco-operative patients Active sites of infection in the area of injection.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Anesthetic effect of 4% Articaine with 1:100,000 epinephrine	Onset: time when the patient starts feeling tingling sensation on the lip | Duration : time when the patient stops feeling any numbness | Duration :

Secondary Outcome Measures

Name	Time	Method
Effect of anesthesia or depth of anesthesia	Any pain during treatment is considered anesthesia failure

Trial Locations

Locations (1)

Sinhgad Dental college and hospital Pune; 🇮🇳 Pune, MAHARASHTRA, India

Sinhgad Dental college and hospital Pune

🇮🇳Pune, MAHARASHTRA, India

Dr Neha Deshpande

Principal investigator

9423581305

nehadeshpande9991@gmail.com