Does injecting a pain killer near the tooth will reduce the pain during root canal treatment
- Conditions
- Subjects undergoing root canal treatment in teeth with symptomatic irreversible pulpitis
- Registration Number
- CTRI/2019/10/021600
- Lead Sponsor
- Faculty of Dentistry self funded
- Brief Summary
Successful local anesthesia is the basis of endodonticmanagement of symptomatic teeth. However, the dental anesthetic injections havea limited success rate in the first attempt. The success rate decrease in thepresence of a preoperative pain. The inferior alveolar nerve block (IANB) isparticularly notorious with high anesthetic failure rates especially in teethassociated with symptomatic pulpitis .1-10 To achieve painless treatment in patients witha failed primary IANB, supplementary anesthesia has been advised .Supplementary intraligamentary (or periodontal injections) and intraosseousinjections have shown promising results .1,2,11 The aim of the supplementary injections is todeposit the local anesthetic solution in the cancellous bone close to the rootapex . An intraligamentary injection is actually a form of intraosseousinjection since the local anesthetic solution is forced via perforations in thedental socket to the cancellous bone around the root . 11-14
**Reviewof literature**: Endodontic treatment can cause the release ofinflammatory mediators into the surrounding periapical tissues.1Thus, pain fibers are directly stimulated or sensitized by prostaglandins *insitu*.3-5 In addition, the vascular dilation and increasedpermeability as consequences of periradicular inflammation cause edema andincreased interstitial tissue response. 3-5 Considering the role ofprostaglandins on endodontic pain, a possible strategy for reduction ofpostoperative endodontic pain might be the local use of an anti-inflammatoryagents adjacent to the inflamed tooth to decrease the production ofinflammatory mediators and improve the efficacy of local anesthetics. The intraligamentary injection was introduced byMalamed in 1982 as an alternative to the conventional inferior alveolar nerveblock.12 Since then it has been evaluated both as primary injectionand as a supplementary injection.15-18 Kaufman et al compared theanesthetic efficacy of plain 2% lidocaine with 2% lidocaine with 1:50,000epinephrine.19 Theauthors reported that duration of anesthesia with plain lidocaine was 1.02 min,while lidocaine with epinephrine had pulpal anesthesia of 27.05 min. Majority of the studies evaluating intraligamentaryinjections have been performed on asymptomatic teeth. 18-21 Very limited research has been dedicated tothe evaluation of different variables in intraligamentary injections in patientswith symptomatic irreversible pulpitis.
**Aim:**
To comparatively evaluate the anesthetic efficacy ofintraligamentary injection of 0.8mL of diclofenac sodium (75mg/3ml) vs. activeplacebo (0.8ml of 2% lidocaine) after a failed inferior alveolar nerve block(IANB), in patients with symptomatic irreversible pulpitis.
**Objective** :
1. To achievepainless treatment in patients with a failed primary IANB. during theendodontic management of symptomatic mandibular first/second molar.
2. To evaluatethe heart rate during and after intraligamentary injections.
*Thenull hypothesis will be that different anesthetic solutions have no effect onthe anesthetic success rate or the heart rate.*
**Materials and Methods:**
Methodology: Prospective, randomized, double-blind clinical trial
Site : Conservative Dentistry, Facultyof Dentistry, Jamia Millia Islamia
N : 30 patients each group
Patientsexperiencing a failed primary IANB shall be enrolled for the study. The initialfailure will be defined as pain (score more than 54 on Heft Parker Visual Analog Scale (VAS) during access cavitypreparation or at root canal instrumentation stage.22 Theprimary outcome (endpoint) will be defined as “success or failure†which willbe indicated as the ability to undertake pulp access and canal instrumentationwith no or mild pain.The secondary outcome will be the evaluation of heart rate after supplementaryintraligamentary injections.
A tentative **samplesize calculation** has beenperformed using data from a previous study , keeping the αlevel type I error at0.05 for a single-tailedtest and β level type II errorat 0.20.19 The analysis indicated that a samplesize of 30subjects would give 80% power to detect a 25% difference in the success rates of the two different supplemental intraligamentaryinjections. For heart rate analysis, it has been calculated that a minimum of23 patients per group shall be required to detect a difference of 10 beats perminutes (with the baseline heart rate of 72 beats per minutes).
The treatmentprocedure and the use of pain scales will be explained to the patients. Acombined VAS,Heft-Parker scale (HP VAS),will be used in the present study.22
I**nclusion criteria** :
1. Symptomatic carious exposed mandibular first or second molars.
2. Positive and prolonged response to thermal sensitivity tests and electric pulp test.
3. Vital coronal pulp on access cavity preparation.
4. American Society of Anesthesiologists class I or II medical history.
5. Ability to understand the use of pain scales.
**Exclusioncriteria**
a. Active pain in more than 1 teeth.
b. Teeth with fused roots.
c. Radiographic evidence of an extra root.
d. Large restorations with overhanging margins.
e. Full crowns or deep periodontal pockets.
f. Known allergy or contraindications toany content of the localanesthetic solution or NSAIDs
g. History of known or suspected drugabuse.
h. Taking any drugs which could affect thepain perception, e.g, opiods, antidepressants, anticonvulsants, musclerelaxants, anxiolytics, sedatives, nsaids. 23
i. Pregnant or breastfeeding patients.
j. Patients with asthma, gastric ulcers,bleeding disorders.
All patients will receive a primary IANB injection using1.8 mL of 2% lidocaine with 1:80 000 epinephrine using a direct Halsted approach. The needle will beinserted until bony resistance will be felt. After reachingthe target area, aspiration will be performed, and the solution will bedeposited over a period of 60seconds. After 10 minutes, the patients will be asked aboutthe lip numbness. Patients without profound lip numbness will be excluded fromthe study since the block will be considered as ‘missed’. A conventionalaccess opening will be initiated after isolation with a rubber dam. Patientswill be instructed to raise their hand if any pain will be felt during theprocedure. In case of pain during treatment, the procedure will be stopped, andthe patientswill be asked to rate the pain on the HP VAS. The patients with failed primary IANB will receivesupplementary intraligamentary injections of 0.8mL of diclofenac sodium(75mg/3ml) or 0.8ml of 2% lidocaine. The injections will be masked with anopaque tape and will be coded with an alpha-numeric code. The code will bebroken only after the completion of the study. The patients will be randomlyallocated to twotreatment groups (n=30per group) with the help of anonline random generator.The rubber dam will be removed and the site of the injection will be cleanedwith an antiseptic solution. The resting heart rate will be monitored with afinger pulse oximeter by a faculty member. The first group will receiveintraligamentary injections of 0.8mL of diclofenac sodium (75mg/3ml). Theinjections will be administered using a pressure type syringe (Osung Deosy, Pearland, Tx, USA) and 30 gauge short needles (Septojet needles, Septodont). The secondgroup will receive intraligamentaryinjections of 2% lidocaine with 1 : 200 000 epinephrine. In both the groups, a total of 0.8 mL of anesthetic solution will bedeposited. The heart rate will be measured at 15-second interval till 5 minutesafter intraligamentary injections. Success will be again defined as no pain or faint/weak/mild pain during endodonticaccess preparation and instrumentation.21
**Statisticalanalysis**: The resultswill be tabulated in contingency tables. The age of patients will be analyzedusing Mann-WhitneyU testat P < .05. The genderand distribution of teeth will be analyzed using 2X2 contingency tables andchi-square tests. The anesthetic success rates will be analyzed with Pearsonchi-square test. The heart rate changes will be analyzed using t-test.
**Sourceof funding**: None
**Conflictsof interest**: None
**Workschedule** : the study is expected to be completed in 2 months
**Technicalsupport required**: None
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1. HargreavesKM, Keiser K. Local anesthetic failure in endodontics: mechanisms andmanagement. Endod Topics 2002 Jan;1:26–39.
2. Meechan JG. Supplementary routes to local anaesthesia. Int EndodJ. 2002 Nov;35:885-96.
3. Aggarwal V, Singla M, Subbiya A et al. Effect of Preoperative Painon Inferior Alveolar Nerve Block. Anesth Prog 2015 Winter;62:135-139.
4. AggarwalV, Jain A, Debipada K. Anesthetic efficacy of supplemental buccal and lingualinfiltrations of articaine and lidocaine following an inferior alveolar nerveblock in patients with irreversible pulpitis. J Endod 2009 Jul;35:925–9.
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7. Webster S Jr, Drum M, Reader A, Fowler S, Nusstein J, Beck M. HowEffective Is Supplemental Intraseptal Anesthesia in Patients withSymptomatic Irreversible Pulpitis? J Endod. 2016 Oct;42:1453-7.
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- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 70
- a.Symptomatic carious exposed mandibular first or second molars.
- b.Positive and prolonged response to thermal sensitivity tests and electric pulp test.
- c.Vital coronal pulp on access cavity preparation.
- d.American Society of Anesthesiologists class I or II medical history.
- e.Ability to understand the use of pain scales.
- a.Active pain in more than 1 teeth.
- b.Teeth with fused roots.
- c.Radiographic evidence of an extra root.
- d.Large restorations with overhanging margins.
- e.Full crowns or deep periodontal pockets.
- f.Known allergy or contraindications to any content of the local anesthetic solution or NSAIDs g.History of known or suspected drug abuse.
- h.Taking any drugs which could affect the pain perception, e.g, opiods, antidepressants, anticonvulsants, muscle relaxants, anxiolytics, sedatives, nsaids.
- 23 i.Pregnant or breastfeeding patients.
- j.Patients with asthma, gastric ulcers, bleeding disorders.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome (endpoint) will be defined as “success or failure†which will be indicated as the ability to undertake pulp access and canal instrumentation with no or mild pain. Primary outcome: success/failure of anesthesia at the end of root canal treatment
- Secondary Outcome Measures
Name Time Method The secondary outcome will be the evaluation of heart rate after supplementary intraligamentary injections. Secondary outcome: Heart rate changes at the end of root canal treatment
Trial Locations
- Locations (1)
Faculty of Dentistry Jamia Millia Islamia
🇮🇳South, DELHI, India
Faculty of Dentistry Jamia Millia Islamia🇮🇳South, DELHI, IndiaDr Vivek AggarwalPrincipal investigator09818188358drvivekaggarwal@gmail.com