A clinical study to compare two supplementary injection techniques using articaine in cases with symptomatic irreversible pulpitis.
- Conditions
- Pulpitis,
- Registration Number
- CTRI/2020/04/024612
- Lead Sponsor
- Dr Harsh Jain
- Brief Summary
**Introduction**
It is believed that reduction inpain perception is necessary for effective endodontic procedure. Therefore, obtaining adequate local anesthesia is highly desirable.However, mandibular molars with symptomatic irreversible pulpitis often do notrespond to conventional inferior alveolar nerve block technique and has beentermed as ‘hot tooth.’1 The theory behind this phenomenon statesthat there is shifting of sodium channel expression from tetradoxin sensitivechannel to tetradoxin resistant channel creating inflammatory hyperalgesia. Insuch cases various anesthetic solutions and supplementary injection techniquesare advocated.2
The difficulty in obtaining anesthesia is also related to variousanatomic complexities like thickness of cortical plates and vertical distanceof nerve in relation to tooth apex, needlephobiaor belanophobia.3
The reduction in pain perception is necessary for effectiveendodontic procedure. Hence, it is essential to utilize supplementaryanesthetic techniques such as buccal infiltration, intra-ligamentary injectionor cryotherepy along with inferior alveolar nerve block.4
Intraligamentary injection is aneasy-to-use technique, which has been used as both a primary injection or assupplementary anesthesia techniques. Intraligamentaryinjection techniques deposit the local anesthetic solution of 0.2 ml on eachclick in the periodontal space. The solution is deposited under strong backpressure. Earlier it was assumed that the high back pressure was responsiblefor providing anesthesia.5
Another recent advancement with local anesthetic armamentarium isMadajet. It is a pressure less syringe system that uses pneumatic pressure todischarge local anesthetics of 0.1 ml/injection, through a calibrated orifice,which makes a wheel of about 5-6mm diameter at the base of injection which iswell accepted by the patient.6
More recently articaine has been suggested asan effective substitute to lignocaine for establishing profound anesthesia insymptomatic irreversible pulpitis cases. It contains theophene ring thatincreases the lipid solubility and infiltration through epineurium of nervemembrane thus, resulting in highersuccess rate.7
In the available literature, thereare limited clinical studies5 that have compared the efficacy ofvarious supplementary injection methods in establishing the profound anesthesiain cases of symptomatic mandibular molars. With the best of our efforts whilesearching the literature we were unable to find any research that utilizedMadajet as a supplementary injection method in cases of symptomaticirreversible pulpitis necessitating endodontic therapy.
Hence, thisresearch proposes to assess the anesthetic efficacy of intraligamentery andbuccal infilration with Madajet as supplementary method along with inferioralveolar nerve block in mandibular molar with Symptomatic irreversible pulpitisnecessitating endodontic therapy.
The null hypothesis of the present studystates that there should be no significant difference in anesthetic efficacy ofinferior alveolar nerve block, intraligamentery and buccal Infiltration withMadajet in patients with Symptomatic irreversible pulpitis.
**AIM & OBJECTIVES:-**
**AIM**– The proposed research is aimed to determinethe anesthetic efficacy of intraligamentery and buccal infilration with Madajetas supplementary method along with inferior alveolar nerve block in mandibularmolar with Symptomatic irreversible pulpitis necessitatingendodontic therapy.
**OBJECTIVE-**
1. To evaluate theanaesthetic efficacy of intraligamentery group in conjunction with inferioralveolar nerve block.
2. To evaluate theanaesthetic efficacy of buccal infilration with Madajet in conjunction withinferior alveolar nerve block.
3. To comparativelyevaluate the efficacy of intraligamentery group and buccal infilration withMadajet in conjunction with inferior alveolar nerve block.
**REVIEW OF LITERATURE**
1. **Fan S,Chen WL, Pan CB *et al* (2009)8;**In a study comparing inferior alveolar nerve block,intraligamentery and buccal infiltration with articaine inmandibular first molars with symptomatic irreversible pulpitis shows thatpatients experience moderate to severe pain with inferior alveolar nerve block with articaine alone. Whereas no pain was recorded for intraligamenteryand buccal infiltration in complimentery with inferior alveolar nerve block.They came to a conclusion that intraligamentery shows higher success rate of 83%and buccal infiltration shows 81% compared with alone IANB, intraligamenteryand buccal infiltration.
2. **Singla M,Subbiya A, Aggarwal V *et al* (2014)9;**Comparison between anesthetic efficacy of 4% articaine (1.8 and 3.6 ml)as supplemental infiltration. In which they came to a conclusion that shows thaton increasing the dose from 1.8 ml to 3.6 ml does not affect the success rateof irreversible pulpitis.
3. **MonteiroMR, Groppo FC, Haiterâ€Neto F *et al*(2014)7;**Performed a study to compare thedifference between 4% articaine withbuccal infiltration and 2% lignocaine with inferior alveolar nerve block inmandibular molar with irreversible pulpitis, In which total 50 patients wererandomly distributed in both group and they came to a conclusion that highersuccess rate seen with articaine in 40% of cases compared with 2% lignocainewhich shows success rate in only 10% of cases.
4. **AggarwalV, Singla M, Miglani S *et al* (2018)3;**Evaluatedon the efficacy of lignocaine vsarticaine as supplemental intraligamentery injection after a failed Inferior alveolar nerve block in which 41volunteers allotted in both the group. They came to a conclusion that articainehas shown success rate of 66 % whereas lignocaine shows success rate of 78% ofcases which concludes that both articaine and lignocaine have improved thesuccess rate after a failed anesthetic injection.
5. **Shahi S, RahimiS, Yavari HR *et al* (2018)4;**Undertooka study to evaluate and compare the successrate of 3 injection methods using articaine for mandibular first molars withsymptomatic irreversible pulpitis and they came to a conclusion that successrate of inferior alveolar nerve block withintraligamentery was 75% and with buccal infiltration 65.6% but none of themethod shows complete success rate.
**6.** **Shapiro MR, McDonald NJ, Gardner RJ *et al* (2018)6;** Evaluated 4% articaine vs 2% lignocaine in supplementary buccalinfiltration in relation to mandibular first vs second molar, from which theycame to a conclusion that success rate was 61% for first molar articaine and66% with lignocaine in comparision to second molar which shows higher successrate 63% using articaine and 35% usinglignocaine.
**MATERIALS AND METHODS**
**MATERIALS**
**1.** Articaine 4% (Septanest, Septodont,France) WithEpinephrine 1:100,000
**2.** 27 Gauge **Needle(Septoject,Septodont,**France**)**
**3.** 30 Gauge Needle**(Septoject,Septodont,**France**)**
**4.** **Madajat (**Mada,medicalproducts,inc, Carlstadt,NJ,USA**)**
**5.** **Intraligamentery Injection (Ligaject, Micromega,France)**
**6.** **Topical Anesthetic 20% benzocaine (Mucopain, Icpa,Mumbai)**
**7.** **Electric Pulp Tester (Denjoy, China )**
**8.****Self Aspirating Syringe**
**9.** Endo-Ice(Neo-snow,Orikem,india)
**METHODOLOGY**
- **TYPE OF STUDY:**
A Randomized Double-blind clinicaltrial an In vivo Study.
- **SOURCE OF THE DATA**
The study will be conducted in the Department of ConservativeDentistry and Endodontics at Chhattisgarh Dental College & ResearchInstitute, Rajnandgaon.
The study is designed according toClinical Trail Registry of India. Prior approval will be taken from theInstitutional Ethics Committee, Chhattisgarh Dental College and ResearchInstitute, Rajnandgoan. All the subjectsincluded in the present study will sign the informed consent forms about thetreatment, its risks and advantages. In addition, the subjects will participatein the study on a voluntary basis. The final sample size will be set at 64 (32subjects in each group) for the α-value of 0.05 and study power of 80%. Todetect a 20% difference in success rate of test group.
P1 **=**75% P2**=**42%
**Minimumsample size ‘N’ with 80% power**
= 7.85\* [P1 (1-P1)+P2 (1-P2)] / (P1-P2)2
=7.85 \* [0.75(1-0.75) +0.42(1-0.42)]/(0.75-0.42)2
On solving
**N=Minimum32 patients in each group**
Prior to study a pilot study will beperformed on 10%(7) participants to check the feasibility of the study.
· **CRITERIA FOR SELECTION OF PATIENT**
The participants will be selected from the patientsreferred to the Endodontics Department of Chhattisgarh Dental College AndResearch Institute, Rajnandgoan . In the present study, patients aged 18-65years, with no periapical pathology but mandibular tooth with symptomaticirreversible pulpitis will be evaluated. After intraoral examinations, thedemo-graphic data of the patients and the locations of teeth will be recorded.The pulp vitality and peri-radicular status of each tooth will be determinedusing thermal and electric pulp tests, followed by palpation, percussion andperiodontal charting. The clinical diagnosis of symptomatic irreversiblepulpitis will be made based on the prolonged response to cold test usingEndoIce (Neoendospray, Orikem,India) and the electric pulp test.
**INCLUSION CRITERIA**:3,4
1. Systemicallyhealthy patients.
2. Patients18–65 years old.
3. Notallergic to articaine or epinephrine.
4. Nofacial paresthesia.
5. Nottaking any analgesic drug 6 hours before treatment.
6. Nottaking any medication that interferes with anesthesia, such as tricyclicantidepressants and beta-blockers.
7. Theabsence of pathogenesis in areas planned for injection.
8. Notpregnant.
9. The absence of pathologic periodontal pockets duringprobing.
10. Patientswith a mandibular molar tooth exhibiting symptomatic irreversible pulpitis.
11. Vitalcoronal pulp on access opening.
12. Americansociety of anesthesiologist class 1 medical history.
13. Theability to understand the use of pain scale.
14. Patientexperiencing greater than moderate pain and spontaneous and prolonged responseto cold testing with Endo-Ice will be included in the study.
15. Teethshowing normal periapical view in the radiograph.
**EXCLUSION CRITERIA:6**
1. A standard inferior alveolar nerve block injection will be performed using articaine 4%with epinephrine 1:100,000. Ten minutes after the injection,the patients will be asked about lip numbness. Patients without profound lipnumbness will be excluded from the study because the block will be considered“missed†which will also be confirmed with electric pulp sensibility test.
2. Participantswith periapical lesions, abscesses or cellulites at the relevant tooth, thosewith a medical treatment history or those having undergone root canal treatmentfor the relevant tooth will also be excluded from the study.
**CLINICAL PROCEDURE:**
All the participants involved in thestudy will be informed about the procedure prior to the treatment. The patienthaving symptomatic irreversible pulpitis in mandibular molar (first and second)and requiring endodontic treatment will be included. In all the groups, topical anesthetic gel(20% benzocaine) will be applied at the site of injection with the help ofsterile gauze piece for 60s prior to administration of inferior alveolar nerve block. To standardize the administration of inferior alveolar nerve block injection will be given using self-aspirating syringe and a 27 gauge needle. The anaesthetic solutionused in all study groups and for all techniques will be articaine 4% (Septanest, Septodont, France) with epinephrine1:100,000. After determining the injection site and aspiration, 1.7 ml ofsolution will be injected at a rate of 1 ml/min4. After 15 min, the use of pain scale willbe explained to the patients, during the latencyperiod, patients will complete a Visual Analogue Scale11 as theirown control to record the amount of pain they experienced on injection.
The VAS scale will be divided into 4 categories.
· Nopain will correspond to 0mm.
· Mildpain will be defined as \_1 mm to \_3 mmand included the description of faint, weak, and mild pain.
· Moderatepain will be defined as \_4 mm to \_5 mm.
·Severe pain will be defined as \_6 mm to \_7mm, including the description of strong, intense, and the maximum possible.
To beincluded in the data analysis all the patients are required to have adequatelip numbness. If the patient does not show profound lip numbness, the blockwill be considered missed and the patient will be excluded the study. Ifpatient reports profound lip numbness the subjects to be included in the studywill be confirmed with the electric pulp testing of the inflamed tooth.6 To prevent the evaluator and participants from identifying thetechniques used, Blinding of the technique will be done through randomization.Randomization will be done by lottery method using chit system. In this processthe type of injection will be written on the chit. To assure the allocationconcealment the color papers will be kept in dark sealed envelope which will beopened by the operator not designated to treat patient. After 10 min according to randomization proceduresupplementary Injections will be further administered if patient respondpositively to Electric pulp testing.10 After the administration ofsupplementary injections again the electric pulp testing will be done toconfirm the anaesthesia of the associated tooth. A blinded evaluatorresponsible for evaluation of pain will assess and record the scores using VAS.
**TREATMENT PROTOCOL**
Patients will be divided into two groups-
Group 1: SupplementaryIntraligamentery injection using 4% articaine with 1:100000 epinephrine.
Group 2: SupplementaryBuccal Infiltration with MADAJET using 4% articaine with 1:100000 withepinephrine.
**GROUP 1** – As per the randomizationprocedure above intraligamentery injection will be given after 15 min to thepatients with failed primary inferior alveolarnerve block. An intraligamentary injection will be performed with aspecial pressure injection syringe **(Ligaject,Micromega,France)** and a 30 gauge needle (septoject, septodont)using 4% articaine 1.100000 epinephrine. The needle willbe placed along the side of tooth and inserted at a 30 degree angle relative tothe longitudinal axis of the crown with the needle between the teeth and thebone axis of the tooth. The handle/trigger will be firmly squeezed to complete2 squeezes which deposited (0.2 × 2 = 0.4) ml solution under strong backpressure. If no back pressure will be felt, then the needle will berepositioned, and the injection will be repeated until back pressure isachieved. The same procedure will be repeated for the distal root.3
**GROUP 2** - Buccal infiltration withMadajet (Mada,medicalproducts,inc Carlstadt, NJ, USA) using 4% articaine withadrenaline 1:100000 will be given after 10 min in the patients with failedprimary inferior alveolar nerve block.Infiltration will be performed at the buccal side of the affected tooth usingMadajet as it is needleless syringe system works on the principal of springthat compress a small internal piston producing a high pressure and emitsanesthetic solution of 0.1 ml/injection, through a calibrated orifice. Thehandle/trigger will be firmly squeezed to complete 4 squeezes which deposited(0.1 × 4 = 0.4) ml solution under strong back pressure and its delivery segmentforms 45 degree angulation with the gingiva producing better and easy andcomplete contact with gingiva, which makes a wheel of about 5-6mm diameter atthe base of injection which is well accepted by the patient.
For all of the included patients,diagnosis and injection will be performed by the first operator, howeverpre-operative and post-operative pain will be assessed by senior endodontistand all the conventional endodontic procedure will be performed by firstoperator.
**STATISTICAL ANALYSIS :**
**Study design:** Prospective Comparative study
**Statistical analysis**
Continuous data will besummarized as Mean ± SD (standard deviation) while discrete (categorical) datain number and percentage.
· Quantitative data will be analyzed by – Mean, SD,Unpaired and paired “T†test.
· Qualitative data will be analyzed by – Chi squaretest, fisher exact test.
Statistical significance
P>0.05 is not significant
P≤0.05 is significant
P≤0.01 is highly significant
Analysis of data will be doneusing Statistics software SPSS 16.0
**REFERENCES**
1. Silva SA,Horliana ACRT, Pannuti CM, et al. Comparative evaluation of anesthetic efficacyof 1.8 mL and 3.6 mL of articaine in irreversible pulpitis of the mandibularmolar: A randomized clinical trial. *PLoS One*. 2019;14(7):1-5.
2. Fowler S,Drum M, Reader A, Beck M. Anesthetic Success of an Inferior Alveolar NerveBlock and Supplemental Articaine Buccal Infiltration for Molars and Premolarsin Patients with Symptomatic Irreversible Pulpitis. *J Endod*.2016;42(3):390–392.
3. AggarwalV, Singla M, Miglani S, Kohli S. Efficacy of Articaine Versus LidocaineAdministered as Supplementary Intraligamentary Injection after a FailedInferior Alveolar Nerve Block: A Randomized Double-blind Study. *J Endod*.2019;45(1):1–5.
4. ShahiS, Rahimi S, Yavari HR, Ghasemi N, Ahmadi F. Success Rate of 3 InjectionMethods with Articaine for Mandibular First Molars with SymptomaticIrreversible Pulpitis: A CONSORT Randomized Double-blind Clinical Trial. *JEndod*. 2018;44(10):1462–1466.
5. Makade CS, ShenoiPR, Gunwal MK. Comparison of acceptance, preference and efficacy betweenpressure anesthesia and classical needle infiltration anesthesia for dentalrestorative procedures in adult patients. *J Conserv Dent*.2014;17(2):169–174.
6. RogersBS, Botero TM, McDonald NJ, Gardner RJ, Peters MC. Efficacy of articaine versuslidocaine as a supplemental buccal infiltration in mandibular molars withirreversible pulpitis: a prospective, randomized, double-blind study. *JEndod*. 2014;40(6):753–758.
7. MonteiroMR, Groppo FC, Haiter-Neto F, Volpato MC, Almeida JF. 4% articaine buccalinfiltration versus 2% lidocaine inferior alveolar nerve block for emergencyroot canal treatment in mandibular molars with irreversible pulpits: arandomized clinical study. *Int Endod J*. 2015;48(2):145–152.
8. FanS, Chen WL, Pan CB, Huang ZQ, Xian MQ, Yang ZH, Dias-Ribeiro E, Liang YC, JiaoJY, Ye YS, Wen TY. Anesthetic efficacy of inferior alveolar nerve block plusbuccal infiltration or periodontal ligament injections with articaine inpatients with irreversible pulpitis in the mandibular first molar. *OralSurg Oral Med Oral Pathol Oral Radiol Endod*. 2009 Nov;108(5):e89-93.
9. SinglaM, Subbiya A, Aggarwal V, Vivekanandhan P, Yadav S, Yadav H, Venkatesh A,Geethapriya N, Sharma V. Comparison of the anaesthetic efficacy of differentvolumes of 4% articaine (1.8 and 3.6 mL) as supplemental buccal infiltrationafter failed inferior alveolar nerve block. *Int Endod J*.2015;48(1):103-108.
10. Dreven LJ, Reader A, Beck M, Meyers WJ,Weaver J. An evaluation of an electric pulp tester as a measure of analgesia inhuman vital teeth. *J Endod*. 1987;13(5):233–238.
11.Klimek L., Bergmann KC, Biedermann T. et al. Visual analogue scales (VAS): Measuringinstruments for the documentation of symptoms and therapy monitoring in casesof allergic rhinitis in everyday health care. Allergo J Int. 2017;26(1):16–24.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 64
- Systemically healthy patients.
- Patients 18–65 years old.
- Not allergic to articaine or epinephrine.
- No facial paresthesia.
- Not taking any analgesic drug 6 hours before treatment.
- Not taking any medication that interferes with anesthesia, such as tricyclic antidepressants and beta-blockers.
- The absence of pathogenesis in areas planned for injection.
- Not pregnant.
- The absence of pathologic periodontal pockets during probing.
- Patients with a mandibular molar tooth exhibiting symptomatic irreversible pulpitis.
- Vital coronal pulp on access opening.
- The ability to understand the use of pain scale.
- Patient experiencing greater than moderate pain and spontaneous and prolonged response to cold testing with Endo-Ice will be included in the study.
- A standard inferior alveolar nerve block injection will be performed using articaine 4% with epinephrine 1:100,000.
- Ten minutes after the injection, the patients will be asked about lip numbness.
- Patients without profound lip numbness will be excluded from the study because the block will be considered “missed†which will also be confirmed with electric pulp sensibility test.
- Participants with periapical lesions, abscesses or cellulites at the relevant tooth, those with a medical treatment history or those having undergone root canal treatment for the relevant tooth will also be excluded from the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Two compare the efficacy of two techniques which will be beneficial for the patients related to pain perception Cross sectional single time
- Secondary Outcome Measures
Name Time Method pain perception with visual analouge scale. before and after intraligamentery and buccal and buccal infiltration
Trial Locations
- Locations (1)
Chhattisgarh Dental Collage and Research institute
🇮🇳Rajnandgaon, CHHATTISGARH, India
Chhattisgarh Dental Collage and Research institute🇮🇳Rajnandgaon, CHHATTISGARH, IndiaDr Harsh JainPrincipal investigator7415630543drharshjain89@gmail.com