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, Haiterâ€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
A Randomized Double-blind clinical
trial an In vivo Study.
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. |