FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2020/04/024612 [Registered on: 14/04/2020] Trial Registered Prospectively
Last Modified On: 11/04/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical study to compare two supplementary injection techniques using articaine in cases with symptomatic irreversible pulpitis. 
Scientific Title of Study   COMPARATIVE EFFICACY OF 2 INJECTION METHODS WITH ARTICAINE FOR TREATMENT IN MANDIBULAR MOLARS WITH SYMPTOMATIC IRREVERSIBLE PULPITIS. A CONSORT RANDOMIZED DOUBLE-BLIND CLINICAL TRIAL : AN IN-VIVO STUDY. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Harsh Jain  
Designation  MDS Student  
Affiliation  Chhattisgarh dental Collage and Research institute  
Address  Room No 5 Department of Conservative Dentistry and Endodontics Chhattisgarh Dental Collage and Research institute sundara rajnandgoan

Rajnandgaon
CHHATTISGARH
491441
India 
Phone  7415630543  
Fax    
Email  drharshjain89@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Prof Naveen chhabra 
Designation  Professor and Head 
Affiliation  Chhattishgarh Dental Collage and Research Institute  
Address  Room No 5 Department of Conservative Dentistry and Endodontics Chhattisgarh dental Collage and Research institute sundara rajnandgoan

Rajnandgaon
CHHATTISGARH
491441
India 
Phone  9426848178  
Fax    
Email  drnaveenchhabra@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Prof Naveen chhabra 
Designation  Professor and Head 
Affiliation  Chhattishgarh Dental Collage and Research Institute  
Address  Room No 5 Department of Conservative Dentistry and Endodontics Chhattisgarh dental Collage and Research institute sundara rajnandgoan

Rajnandgaon
CHHATTISGARH
491441
India 
Phone  9426848178  
Fax    
Email  drnaveenchhabra@yahoo.com  
 
Source of Monetary or Material Support  
Self funded by Primary investigator 
 
Primary Sponsor  
Name  Dr Harsh Jain  
Address  Room No 5 Department of Conservative Dentistry and Endodontics Chhattisgarh dental Collage and Research institute. sundara, Rajnandgoan  
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Harsh Jain  Chhattisgarh Dental Collage and Research institute   Room No 5 Department of Conservative Dentistry and Endodontics Chhattisgarh Dental Collage and Research institute sundara rajnandgoan
Rajnandgaon
CHHATTISGARH 
7415630543

drharshjain89@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
CHHATTISGARH DENTAL COLLAGE AND RESEARCH INSTITUTE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K040||Pulpitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  supplimentery injection of intraliagmentery with articaine   0.2 ml 2 times after inferior alveolar nerve block 
Intervention  supplimentery injection of madajet with articaine  0.1 ml 4 times after inferior alveolar nerve block 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Systemically healthy patients.
2. Patients 18–65 years old.
3. Not allergic to articaine or epinephrine.
4. No facial paresthesia.
5. Not taking any analgesic drug 6 hours before treatment.
6. Not taking any medication that interferes with anesthesia, such as tricyclic antidepressants and beta-blockers.
7. The absence of pathogenesis in areas planned for injection.
8. Not pregnant.
9. The absence of pathologic periodontal pockets during probing.
10. Patients with a mandibular molar tooth exhibiting symptomatic irreversible pulpitis.
11. Vital coronal pulp on access opening.
12. American society of anesthesiologist class 1 medical history.
13. The ability to understand the use of pain scale.
14. Patient experiencing greater than moderate pain and spontaneous and prolonged response to cold testing with Endo-Ice will be included in the study.
15. Teeth showing normal periapical view in the radiograph. 
 
ExclusionCriteria 
Details  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 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.
2. 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. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Two compare the efficacy of two techniques which will be beneficial for the patients related to pain perception   Cross sectional single time  
 
Secondary Outcome  
Outcome  TimePoints 
pain perception with visual analouge scale.  before and after intraligamentery and buccal and buccal infiltration  
 
Target Sample Size   Total Sample Size="64"
Sample Size from India="64" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   16/04/2020 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not applicable  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Introduction

It is believed that reduction in pain perception is necessary for effective endodontic procedure. Therefore, obtaining adequate local anesthesia is highly desirable. However, mandibular molars with symptomatic irreversible pulpitis often do not respond to conventional inferior alveolar nerve block technique and has been termed as ‘hot tooth.’1 The theory behind this phenomenon states that there is shifting of sodium channel expression from tetradoxin sensitive channel to tetradoxin resistant channel creating inflammatory hyperalgesia. In such cases various anesthetic solutions and supplementary injection techniques are advocated.2

The difficulty in obtaining anesthesia is also related to various anatomic complexities like thickness of cortical plates and vertical distance of nerve in relation to tooth apex, needlephobia or belanophobia.3

The reduction in pain perception is necessary for effective endodontic procedure. Hence, it is essential to utilize supplementary anesthetic techniques such as buccal infiltration, intra-ligamentary injection or cryotherepy along with inferior alveolar nerve block.4

Intraligamentary injection is an easy-to-use technique, which has been used as both a primary injection or as supplementary anesthesia techniques. Intraligamentary injection techniques deposit the local anesthetic solution of 0.2 ml on each click in the periodontal space. The solution is deposited under strong back pressure. Earlier it was assumed that the high back pressure was responsible for providing anesthesia.5

Another recent advancement with local anesthetic armamentarium is Madajet. It is a pressure less syringe system that uses pneumatic pressure to discharge 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 is well accepted by the patient.6

More recently articaine has been suggested as an effective substitute to lignocaine for establishing profound anesthesia in symptomatic irreversible pulpitis cases. It contains theophene ring that increases the lipid solubility and infiltration through epineurium of nerve membrane  thus, resulting in higher success rate.7 

In the available literature, there are limited clinical studies5 that have compared the efficacy of various supplementary injection methods in establishing the profound anesthesia in cases of symptomatic mandibular molars. With the best of our efforts while searching the literature we were unable to find any research that utilized Madajet as a supplementary injection method in cases of symptomatic irreversible pulpitis necessitating endodontic therapy.

Hence, this research proposes to assess the anesthetic efficacy of intraligamentery and buccal infilration with Madajet as supplementary method along with inferior alveolar nerve block in mandibular molar with Symptomatic irreversible pulpitis necessitating endodontic therapy.

The null hypothesis of the present study states that there should be no significant difference in anesthetic efficacy of inferior alveolar nerve block, intraligamentery and buccal Infiltration with Madajet in patients with Symptomatic irreversible pulpitis.

AIM & OBJECTIVES:-

 

AIM– The proposed research is aimed to determine the anesthetic efficacy of intraligamentery and buccal infilration with Madajet as supplementary method along with inferior alveolar nerve block in mandibular molar with Symptomatic irreversible pulpitis necessitating endodontic therapy.

 

OBJECTIVE-

1.     To evaluate the anaesthetic efficacy of intraligamentery group in conjunction with inferior alveolar nerve block.

2.     To evaluate the anaesthetic efficacy of buccal infilration with Madajet in conjunction with inferior alveolar nerve block.

3.     To comparatively evaluate the efficacy of intraligamentery group and buccal infilration with Madajet 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 in mandibular first molars with symptomatic irreversible pulpitis shows that patients experience moderate to severe pain with inferior alveolar nerve block with articaine alone.  Whereas no pain was recorded for intraligamentery and 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, intraligamentery and 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 that on increasing the dose from 1.8 ml to 3.6 ml does not affect the success rate of irreversible pulpitis.

 

3.     Monteiro MR, Groppo FC, Haiter‐Neto F et al (2014)7; Performed a study to compare the difference between 4% articaine with buccal infiltration and 2% lignocaine with inferior alveolar nerve block in mandibular molar with irreversible pulpitis, In which total 50 patients were randomly distributed in both group and they came to a conclusion that higher success rate seen with articaine in 40% of cases compared with 2% lignocaine which shows success rate in only 10% of cases.

4.     Aggarwal V, Singla M, Miglani S et al (2018)3; Evaluated on the efficacy of lignocaine vs articaine as supplemental intraligamentery injection after a failed Inferior alveolar nerve block in which 41 volunteers allotted in both the group. They came to a conclusion that articaine has shown success rate of 66 % whereas lignocaine shows success rate of 78% of cases which concludes that both articaine and lignocaine have improved the success rate after a failed anesthetic injection.

5.     Shahi S, Rahimi S, Yavari HR et al (2018)4; Undertook a study to evaluate and compare the success rate of 3 injection methods using articaine for mandibular first molars with symptomatic irreversible pulpitis and they came to a conclusion that success rate of inferior alveolar nerve block with intraligamentery was 75% and with buccal infiltration 65.6% but none of the method shows complete success rate.

6.     Shapiro MR, McDonald NJ, Gardner RJ et al (2018)6; Evaluated 4% articaine vs 2% lignocaine in supplementary buccal infiltration in relation to mandibular first vs second molar, from which they came to a conclusion that success rate was 61% for first molar articaine and 66% with lignocaine in comparision to second molar which shows higher success rate 63% using articaine  and 35% using lignocaine.

 


 

MATERIALS AND METHODS

 

MATERIALS

 

1.     Articaine 4% (Septanest, Septodont,France) With Epinephrine 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 clinical trial an In vivo Study.

 

  • SOURCE OF THE DATA

The study will be conducted in the Department of Conservative Dentistry and Endodontics at Chhattisgarh Dental College & Research Institute, Rajnandgaon.

The study is designed according to Clinical Trail Registry of India. Prior approval will be taken from the Institutional Ethics Committee, Chhattisgarh Dental College and Research Institute, Rajnandgoan.  All the subjects included in the present study will sign the informed consent forms about the treatment, its risks and advantages. In addition, the subjects will participate in the study on a voluntary basis. The final sample size will be set at 64 (32 subjects in each group) for the α-value of 0.05 and study power of 80%. To detect a 20% difference in success rate of test group.

P1 =75%    P2=42%

 

Minimum sample 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=Minimum 32 patients in each group

 

Prior to study a pilot study will be performed on 10%(7) participants to check the feasibility of the study.

 

·       CRITERIA FOR SELECTION OF PATIENT

The participants will be selected from the patients referred to the Endodontics Department of Chhattisgarh Dental College And Research Institute, Rajnandgoan . In the present study, patients aged 18-65 years, with no periapical pathology but mandibular tooth with symptomatic irreversible pulpitis will be evaluated. After intraoral examinations, the demo-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 determined using thermal and electric pulp tests, followed by palpation, percussion and periodontal charting. The clinical diagnosis of symptomatic irreversible pulpitis will be made based on the prolonged response to cold test using EndoIce (Neoendospray, Orikem,India) and the electric pulp test.

 

INCLUSION CRITERIA:3,4

1.     Systemically healthy patients.

2.     Patients 18–65 years old.

3.     Not allergic to articaine or epinephrine.

4.     No facial paresthesia.

5.     Not taking any analgesic drug 6 hours before treatment.

6.     Not taking any medication that interferes with anesthesia, such as tricyclic antidepressants and beta-blockers.

7.     The absence of pathogenesis in areas planned for injection.

8.     Not pregnant.

9.     The absence of pathologic periodontal pockets during probing.

10.  Patients with a mandibular molar tooth exhibiting symptomatic irreversible pulpitis.

11.  Vital coronal pulp on access opening.

12.  American society of anesthesiologist class 1 medical history.

13.  The ability to understand the use of pain scale.

14.  Patient experiencing greater than moderate pain and spontaneous and prolonged response to cold testing with Endo-Ice will be included in the study.

15.  Teeth showing 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 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.

2.     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.

 

CLINICAL PROCEDURE:

 

All the participants involved in the study will be informed about the procedure prior to the treatment. The patient having 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 of sterile 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 solution used in all study groups and for all techniques will be articaine 4% (Septanest, Septodont, France) with epinephrine 1:100,000. After determining the injection site and aspiration, 1.7 ml of solution will be injected at a rate of 1 ml/min4. After 15 min, the use of pain scale will be explained to the patients, during the latency period, patients will complete a Visual Analogue Scale11 as their own control to record the amount of pain they experienced on injection.

The  VAS scale will be divided into 4 categories.

·       No pain will correspond to 0mm.

·       Mild pain will be defined as _1 mm to _3  mm and included the description of faint, weak, and mild pain.

·       Moderate pain will be defined as _4 mm to _5 mm.

·            Severe pain will be defined as _6 mm to _7 mm, including the description of strong, intense, and the maximum possible.

To be included in the data analysis all the patients are required to have adequate lip numbness. If the patient does not show profound lip numbness, the block will be considered missed and the patient will be excluded the study. If patient reports profound lip numbness the subjects to be included in the study will be confirmed with the electric pulp testing of the inflamed tooth.6 To prevent the evaluator and participants from identifying the techniques used, Blinding of the technique will be done through randomization. Randomization will be done by lottery method using chit system. In this process the type of injection will be written on the chit. To assure the allocation concealment the color papers will be kept in dark sealed envelope which will be opened by the operator not designated to treat patient. After 10 min according to randomization procedure supplementary Injections will be further administered if patient respond positively to Electric pulp testing.10 After the administration of supplementary injections again the electric pulp testing will be done to confirm the anaesthesia of the associated tooth. A blinded evaluator responsible for evaluation of pain will assess and record the scores using VAS.

TREATMENT PROTOCOL

Patients will be divided into  two groups-

Group 1: Supplementary Intraligamentery injection using 4% articaine with 1:100000 epinephrine.

Group 2: Supplementary Buccal Infiltration with MADAJET using 4% articaine with 1:100000 with epinephrine.       

                                                                                                                                                           

GROUP 1 – As per the randomization procedure above intraligamentery injection will be given after 15 min to the patients with failed primary inferior alveolar nerve block. An intraligamentary injection will be performed with a special pressure injection syringe (Ligaject ,Micromega,France) and a 30 gauge needle (septoject, septodont) using 4% articaine 1.100000 epinephrine. The needle will be placed along the side of tooth and inserted at a 30 degree angle relative to the longitudinal axis of the crown with the needle between the teeth and the bone axis of the tooth. The handle/trigger will be firmly squeezed to complete 2 squeezes which deposited (0.2 × 2 = 0.4) ml solution under strong back pressure. If no back pressure will be felt, then the needle will be repositioned, and the injection will be repeated until back pressure is achieved. The same procedure will be repeated for the distal root.3

 

GROUP 2 - Buccal infiltration with Madajet (Mada,medicalproducts,inc Carlstadt, NJ, USA) using 4% articaine with adrenaline 1:100000 will be given after 10 min in the patients with failed primary inferior alveolar nerve block. Infiltration will be performed at the buccal side of the affected tooth using Madajet as it is needleless syringe system works on the principal of spring that compress a small internal piston producing a high pressure and emits anesthetic solution of 0.1 ml/injection, through a calibrated orifice. The handle/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 segment forms 45 degree angulation with the gingiva producing better and easy and complete contact with gingiva, which makes a wheel of about 5-6mm diameter at the 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, however pre-operative and post-operative pain will be assessed by senior endodontist and all the conventional endodontic procedure will be performed by first operator.

STATISTICAL ANALYSIS :

Study design: Prospective Comparative study

Statistical analysis

Continuous data will be summarized as Mean ± SD (standard deviation) while discrete (categorical) data in number and percentage.

·       Quantitative data will be analyzed by – Mean, SD, Unpaired and paired “T” test.

·       Qualitative data will be analyzed by – Chi square test, 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 done using Statistics software SPSS 16.0

REFERENCES

1.     Silva SA, Horliana ACRT, Pannuti CM, et al. Comparative evaluation of anesthetic efficacy of 1.8 mL and 3.6 mL of articaine in irreversible pulpitis of the mandibular molar: 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 Nerve Block and Supplemental Articaine Buccal Infiltration for Molars and Premolars in Patients with Symptomatic Irreversible Pulpitis. J Endod. 2016;42(3):390–392.

3.     Aggarwal V, Singla M, Miglani S, Kohli S. Efficacy of Articaine Versus Lidocaine Administered as Supplementary Intraligamentary Injection after a Failed Inferior Alveolar Nerve Block: A Randomized Double-blind Study. J Endod. 2019;45(1):1–5.

4.     Shahi S, Rahimi S, Yavari HR, Ghasemi N, Ahmadi F. Success Rate of 3 Injection Methods with Articaine for Mandibular First Molars with Symptomatic Irreversible Pulpitis: A CONSORT Randomized Double-blind Clinical Trial. J Endod. 2018;44(10):1462–1466.

5.     Makade CS, Shenoi PR, Gunwal MK. Comparison of acceptance, preference and efficacy between pressure anesthesia and classical needle infiltration anesthesia for dental restorative procedures in adult patients. J Conserv Dent. 2014;17(2):169–174.

6.     Rogers BS, Botero TM, McDonald NJ, Gardner RJ, Peters MC. Efficacy of articaine versus lidocaine as a supplemental buccal infiltration in mandibular molars with irreversible pulpitis: a prospective, randomized, double-blind study. J Endod. 2014;40(6):753–758.

7.     Monteiro MR, Groppo FC, Haiter-Neto F, Volpato MC, Almeida JF. 4% articaine buccal infiltration versus 2% lidocaine inferior alveolar nerve block for emergency root canal treatment in mandibular molars with irreversible pulpits: a randomized clinical study. Int Endod J. 2015;48(2):145–152.

8.     Fan S, Chen WL, Pan CB, Huang ZQ, Xian MQ, Yang ZH, Dias-Ribeiro E, Liang YC, Jiao JY, Ye YS, Wen TY. Anesthetic efficacy of inferior alveolar nerve block plus buccal infiltration or periodontal ligament injections with articaine in patients with irreversible pulpitis in the mandibular first molar. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2009 Nov;108(5):e89-93.

9.     Singla M, Subbiya A, Aggarwal V, Vivekanandhan P, Yadav S, Yadav H, Venkatesh A, Geethapriya N, Sharma V. Comparison of the anaesthetic efficacy of different volumes of 4% articaine (1.8 and 3.6 mL) as supplemental buccal infiltration after 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 in human vital teeth. J Endod. 1987;13(5):233–238.

11.Klimek L., Bergmann KC, Biedermann T. et al. Visual analogue scales (VAS): Measuring instruments for the documentation of symptoms and therapy monitoring in cases of allergic rhinitis in everyday health care. Allergo J Int. 2017;26(1):16–24.


 
Close