| CTRI Number |
CTRI/2021/05/033659 [Registered on: 17/05/2021] Trial Registered Prospectively |
| Last Modified On: |
13/05/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Is combination of buccal plus palatal injection better than the buccal alone during the endodontic treatment of maxillary molars using 2% lidocaine and 4articaine with same adrenaline concentration- A clinical study |
|
Scientific Title of Study
|
Comparison in the anesthetic efficacy of buccal, buccal plus palatal infiltration of 2% lidocaine and 4% articaine buccal infiltration in vital symptomatic maxillary molars: a prospective double blind randomized clinical trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Umesh KUMAR |
| Designation |
Assistant Professor  and In-charge |
| Affiliation |
Pgimer |
| Address |
room no 101, Unit of Conservative Dentistry & Endodontics
Oral Health Sciences Centre
Post Graduate Institute of Medical Education & Research Chandigarh 160012 India
Ohsc, pgi
Chandigarh
CHANDIGARH
160012
India |
| Phone |
09862969792 |
| Fax |
|
| Email |
odharmani911@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Umesh KUMAR |
| Designation |
Assistant Professor |
| Affiliation |
Pgimer |
| Address |
room no 101, Unit of Conservative Dentistry & Endodontics
Oral Health Sciences Centre
Post Graduate Institute of Medical Education & Research Chandigarh 160012 India
Ohsc, pgi
Chandigarh
CHANDIGARH
160012
India |
| Phone |
09862969792 |
| Fax |
|
| Email |
odharmani911@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Umesh KUMAR |
| Designation |
Assistant Professor |
| Affiliation |
Pgimer |
| Address |
room no 101, Unit of Conservative Dentistry & Endodontics
Oral Health Sciences Centre
Post Graduate Institute of Medical Education & Research Chandigarh 160012 India
Ohsc, pgi
Chandigarh
CHANDIGARH
160012
India |
| Phone |
09862969792 |
| Fax |
|
| Email |
odharmani911@gmail.com |
|
|
Source of Monetary or Material Support
|
|
Post Graduate Institute of Medical Education & Research Chandigarh
160012
India |
|
|
Primary Sponsor
|
| Name |
Department of Oral Health Science Centre |
| Address |
Post Graduate Institute of Medical Education and Research,
Chandigarh
|
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Dr Umesh Kumar |
Post Graduate Institute of Medical Education and Research |
ROOM NO 101
Unit of Conservative Dentistry & Endodontics
Department of Oral Health Sciences Centre,
Chandigarh
CHANDIGARH |
09862969792
odharmani911@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethical Committee,Post Graduate Institute of Medical Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
SYMPTOMATIC IRRVERSIBLE PULPITIS |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
4% ARTICAINE |
To compare the efficacy of buccal, buccal plus palatal infiltration with 2% lidocaine and buccal infiltration with 4% articaine alone to achieve pulpal anaesthesia |
| Intervention |
LIDOCAINE 2% |
To compare the efficacy of buccal, buccal plus palatal infiltration with 2% lidocaine and buccal infiltration with 4% articaine alone to achieve pulpal anaesthesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
The inclusion criteria for the study were as follows: moderate to severe pain in the maxillary first molar, a prolonged response to cold testing with an ice stick and an electric pulp tester (Kerr Pulp Tester; Analytic Technology Corp, Redmond, WA), the absence of any periapical radiolucency on radiographs except for a widened periodontal ligament, a vital coronal pulp on access opening, and the ability of the subject to understand the use of pain scales. The subjects were in good health, and none were taking any medication that would alter pain perception, as determined by oral questioning and a written questionnaire.
|
|
| ExclusionCriteria |
| Details |
The exclusion criteria for the study were as follows: subjects younger than 18 years of age or older than 50 years of age, any known sensitivity to either 2% lidocaine or 4% articaine or epinephrine, patients having active pain in more than 1 maxillary molar, subject taking any pain-relieving medication including over-the-counter analgesics at least 12 hours before enrollment in the study, and swelling near the tooth in question and having a tooth not suitable for simple restorative treatment because of extensive caries or periodontal problems. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Buccal infiltration injection alone effective in the maxillary molars pulpal anesthesia |
2 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 3. 4% articaine with adrenaline is more effective than 2% lidocaine with adrenaline as an infiltration anaesthetic |
2 hours |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
25/05/2021 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
non yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The purpose of present study will plane the role of supplemental palatal infiltration or 4% articaine on the success rate of pulpal anesthesia of maxillary molars with symptomatic irreversible pulpitis. Sixty six adult volunteer subjects will be selected from dental OPD. The subjects should be actively experiencing pain and in good health, and none will be taking any medication that would alter pain perception. The patients were randomly divided into three groups (GROUP I, II, III) twenty each. Patients will mark their pretreatment pain on a 170-mm HP VAS (12). Patients will receive in GROUP I: buccal infiltration1 of 1.8 mL lidocaine plus dummy palatal injection (BL), GROUP II) buccal plus palatal infiltrations of 2 mL lidocaine (BLL) and GROUP III buccal infiltration of 1.8 mL articaine plus dummy lingual injection (BA). The patients will be asked to rate their pain on HP VAS after 20 minutes of the infiltration during the conventional access opening procedure after rubber dam application. Success will be defined as no pain or weak/mild pain during endodontic access preparation and instrumentation (Heft-Parker VAS score<55mm). Age with initial and post injection pain of the subjects will be evaluated using multiple comparison analyses of variance (Kruskal-Wallis) and t tests at P < .05. Anesthetic success of all groups will be compared by using nonparametric chi-square χ2 test. |