| CTRI Number |
CTRI/2016/12/007610 [Registered on: 23/12/2016] Trial Registered Retrospectively |
| Last Modified On: |
22/12/2016 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of two anesthestic agents in irreversible pulpitis cases of upper first molar. |
|
Scientific Title of Study
|
comparative evaluation of anesthetic efficacy of 4% articaine and 2% lidocaine for buccal infiltration in adult patients with irreversible pulpitis of maxillary first molar: A prospective randomized study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1188-4967 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Syed Gufaran Ali |
| Designation |
Reader |
| Affiliation |
Modern Dental College And Research centre |
| Address |
House number 13
Dilip Nagar
Near Qadri Kirana store
Khajrana
Indore
Indore
MADHYA PRADESH
452056
India |
| Phone |
9826406933 |
| Fax |
|
| Email |
drgufran81@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sanjyot Mulay |
| Designation |
Professor HOD and Guide |
| Affiliation |
DY Patil Dental College Pune |
| Address |
Sant Tukaram Nagar
Pimpri-Chinchwad
Pune
MAHARASHTRA
411018
India |
| Phone |
9822036048 |
| Fax |
|
| Email |
sanjyotmulay@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Syed Gufaran Ali |
| Designation |
Reader |
| Affiliation |
Modern Dental College And Research centre |
| Address |
House number 13
Dilip Nagar
Near Qadri Kirana store
Khajrana
Indore
Indore
MADHYA PRADESH
452056
India |
| Phone |
9826406933 |
| Fax |
|
| Email |
drgufran81@gmail.com |
|
|
Source of Monetary or Material Support
|
| Modern Dental College & Research Centre, Indore |
|
|
Primary Sponsor
|
| Name |
Syed Gufaran Ali |
| Address |
House number 13
Dilip Nagar
Near Qadri Kirana store
Khajrana
Indore |
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Syed Gufaran Ali |
Department Of Conservative And Endodontics And Private Clinics |
Room no 24
Staff Section
First Floor
Modern Dental College and Research Center
Indore
MADHYA PRADESH |
9826406933
drgufran81@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research Board Of University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Irreversible Pulpitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Articaine |
4% Articaine 1:100,000
0.8ml Buccal infiltration Given once Pain Score observed after 7 minutes |
| Comparator Agent |
Lidocaine |
2% Lidocaine 1:100,000
1.6ml Buccal infiltration Given once Pain Score observed after 7 minutes |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients having Moderate to severe pain in maxillary 1st molar tooth along with a positive response to cold testing with an ice stick & an electric pulp tester.
2. The ability of the patient to understand the use of pain scales.
3. The patient should be in good health & none should take any medication that would alter pain perception, as determined by oral & written questionnaire in last 24 hrs.
4. Absence of any periapical radiolucency on radiographs except for a widened periodontal ligament
|
|
| ExclusionCriteria |
| Details |
1. Patients with systemic disorder like diabetes, hypertension, asthma etc.
2. Patient having active pain in more than one maxillary molar in same quadrant.
3. Subjects taking any pain relieving medication including analgesics within last 24 hrs.
4. Subjects taking any antibiotics within 4 weeks before enrolment in the study.
5. Swelling associated with the tooth in question.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Both male and female patients experienced significantly less pain in Articaine group as compared to Lidocaine group.
2. the anesthetic efficacy of 2% Lidocaine is less as compared to 4% Articaine.
3. The anesthetic efficacy of buccal infiltration using 4% articaine is comparable with 2% Lidocaine but 4% Articaine has been found to be better than 2% Lidocaine because only 0.8 ml of 4% Articaine was injected as opposed to 1.6 ml of 2% Lidocaine.
|
Initial pain and pain after 7 minutes of injection |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. In all the failed cases in both the groups, patients had moderate to severe pain while inserting the file in palatal canals only.
2. In failed cases of both the groups female patients experienced more pain as compared to the male patients, however, it is not statistically significant in Articaine group but it is significant in Lidocaine group. |
Initial pain and pain after 7 minutes of injection |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
17/08/2015 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Aim- To Compare and evaluate the anesthetic efficacy of
4% Articaine and 2% Lidocaine for buccal infiltration in adult patients with irreversible
pulpitis of maxillary first molar.
Materials and methods:
1.
200 adult
subjects with symptomatic irreversible pulpitis in maxillary first molar were selected by simple sequential randomization procedure (Coin toss method). 2. They were randomly allocated to two groups Group 1 (n-100) and Group 2 (n-100). Each
group was further subdivided into two subgroups (n-50 each):
a. Group 1:
Group 1A: Buccal infiltration anesthesia with 4% articaine in
males.
Group 1B: Buccal infiltration anesthesia with 4% articaine in
females.
b. Group 2:
Group
2A: Buccal infiltration anesthesia with 2% lidocaine in
males. Group 2B: Buccal infiltration anesthesia with 2% lidocaine in
females.
3.
On random basis,
50 male patients (Group 1A) were given submucosal buccal infiltration with
4% articaine. Same procedure was done for, 50 female patients (Group 1B). 4. The procedure was repeated for Group 2A and 2B by giving submucosal buccal infiltration with 2% lidocaine. 5. After 7 min of
injection, the patients were again asked to rate their pain on Heft-Parker
VAS. 6. The extent of
access preparation and/or instrumentation was recorded as within dentin,
within pulpal space & the insertion of 1st instrument in the
canal till the working length using apex locator. 7. The success was defined as “no pain (0 mm)†or “weak/mild pain (˃ 0 mm & ≤ 54 mm.)â€
during endodontic access preparation & during first file insertion till
working length, and the failure was defined as “Moderate pain (˃ 54 mm
& ˂ 114 mm)†or “severe pain (≥ 114 mm)†during endodontic access
preparation & during first file insertion till working length.
Statistical analysis: “Unpaired
t test†and “chi-square test†was used to determine significant differences
with 95% confidence level at P < 0.05 (SPSS software v. 20). Result:
On comparison of both
the groups, statistical analysis reveals that the anesthetic efficacy of buccal
infiltration using 4% articaine in
patients with irreversible pulpitis of maxillary 1st molar is
comparable with 2% Lidocaine. But 4% Articaine has been found to be better than
2% Lidocaine because only 0.8 ml of 4% Articaine was injected as oppose to 1.6
ml of 2% Lidocaine.
|