| CTRI Number |
CTRI/2020/09/027796 [Registered on: 14/09/2020] Trial Registered Prospectively |
| Last Modified On: |
26/01/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
comparison between efficacy of different local anesthetics |
|
Scientific Title of Study
|
A Comparative Evaluation of Efficacy of Inferior Alveolar Nerve Block with Conventional, Pre-heated and Buffered 2% Lignocaine in Patients with Symptomatic Irreversible Pulpitis- A Randomized Clinical 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 Namita Gandhi |
| Designation |
MDS student |
| Affiliation |
Department of conservative dentistry and endodontics , KM Shah dental college |
| Address |
Department of conservative dentistry and endodontics,dept no -8. KM shah Dental college, Waghodia Road, Piparia, Taluk Waghodia, Vadodara, Gujarat 391760
Vadodara
GUJARAT
391760
India |
| Phone |
|
| Fax |
|
| Email |
namitagandhi95@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nimisha shah |
| Designation |
HOD , Professor of Department of conservative dentistry and endodontics |
| Affiliation |
HOD,and Professor of conservative dentistry and endodontics. KM shah dental college |
| Address |
Department of conservative dentistry and endodontics,dept no -8. KM shah Dental college, Waghodia Road, Piparia,
Vadodara
GUJARAT
391760
India |
| Phone |
|
| Fax |
|
| Email |
nshah7873@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Namita Gandhi |
| Designation |
MDS student |
| Affiliation |
Pg student , conservative dentistry and endodontics. KM shah dental college |
| Address |
Department of conservative dentistry and endodontics,dept no -8. KM shah Dental college, Waghodia Road, Piparia,
Vadodara
GUJARAT
391760
India |
| Phone |
|
| Fax |
|
| Email |
namitagandhi95@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of conservative dentistry and endodontics,dept no -8. KM shah Dental college, Waghodia Road, Piparia, |
|
|
Primary Sponsor
|
| Name |
Dr Namita Gandhi |
| Address |
room no -121,Dhanwantri hostel,sumandeep vidyapeeth ,Waghodia Road, Piparia, Taluk Waghodia, Vadodara, Gujarat 391760 |
| Type of Sponsor |
Other [self] |
|
|
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 Namita Gandhi |
K M Shah Dental College and Hospita |
Department of conservative dentistry and endodontics,dept no -8. KM shah Dental college, Waghodia Road, Piparia,
Vadodara
GUJARAT |
9922470078
namitagandhi95@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| sumandeep vidyapeeth institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K040||Pulpitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Anesthetic agent |
Group A: 1.8 ml of Preheated lidocaine with 1:80000 epinephrine , by inferior alveolar nerve block, duration of action -3hrs |
| Intervention |
Anesthetic agent |
Group B: 1.8 ml of Buffered lidocaine with 1:80000 epinephrine , by inferior alveolar nerve block, duration of action -3hrs
Buffered by-Freshly prepared Buffered local anesthetic solution will be used, though self-life of solution is 1 week , for maximum efficacy it will be prepared once in 2 days.
 Preparation of buffered local anesthetic solution will be done under supervision in the college of pharmacy.
 The buffered local anesthetic solution will be stored in refrigerator.
 Under sterile conditions, 0.18 mL from a 1.8-mL vial of 2% lidocaine with 1:80,000 epinephrine will be drawn.
 It will be replaced with 0.18 mL 8.4% sodium bicarbonate using a 1 ml plastic syringe.
 The cartridge will be inverted 5 times to mix the solution, and no precipitation should be present. It will be shaken until the solution will be clear; to ensure that sodium bicarbonate is dissolved completely.
 The Cartridge will be loaded into metal syringe and then injected.
|
| Comparator Agent |
Anesthetic agent |
Group C: 1.8 ml of lidocaine with 1:80000 epinephrine , by inferior alveolar nerve block, duration of action -3hrs |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Both male and female patients between 18-60 years of age will be included in the study.
2. Patients diagnosed with symptomatic irreversible pulpitis with or without apical periodontitis. 34
3. Patient should have actively experienced moderate to severe pain pre operatively on VAS scale.32
4. A written informed consent will be taken from all the patients and only those patients ready to sign the consent form will be included in the study.
5. Patients diagnosed with symptomatic irreversible pulpitis in mandibular molar teeth will be included in study. |
|
| ExclusionCriteria |
| Details |
Patients allergic to local anesthetics or known allergy to sodium bicarbonates will be excluded from study.
2. Pregnant and lactating patients will be excluded from study.
3. Patients taking any analgesics, antibiotics, sedatives, and antianxiety drugs on regular basis or before 24 hrs. of treatment will be excluded.
4. Patient having history of significant medical condition will be excluded from study.
5. Patient having necrosed tooth with sinus tracts/local gum swelling around the affected tooth.
6. Patients with severe periodontitis and poor oral hygiene. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1.To evaluate the efficacy of preheated local anaesthetic ie. 2% Lignocaine in patient with symptomatic irreversible pulpitis on giving inferior alveolar nerve block checked on VAS scale. 2.To evaluate efficacy of buffered local anaesthetic ie.2% Lignocaine on VAS scale.3.To evaluate efficacy of conventional local anaesthetic ie. 2% Lignocaine checked on VAS scale.4.To compare the efficacy of conventional, pre-heated and buffered local anesthetics ie. 2% Lignocaine checked on VAS scale. |
pre and post operatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare pain on injection between conventional, pre-heated and buffered local anaesthetic ie. 2% Lignocaine in patients with symptomatic irreversible pulpitis on Administrating inferior alveolar nerve block checked on VAS scale on mandibular posterior teeth. |
after inferior alveolar nerve block |
|
|
Target Sample Size
|
Total Sample Size="180"
Sample Size from India="180"
Final Enrollment numbers achieved (Total)= "252"
Final Enrollment numbers achieved (India)="252" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/09/2020 |
| Date of Study Completion (India) |
03/01/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="0"
Months="9"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
.To compare the efficacy of conventional, pre-heated and buffered local anesthetics ie. 2% Lignocaine in patients with symptomatic irreversible pulpitis on giving inferior alveolar nerve block checked on VAS scale. To compare pain on injection between conventional, pre-heated and buffered local anaesthetic ie. 2% Lignocaine in patients with symptomatic irreversible pulpitis on Administrating inferior alveolar nerve block checked on VAS scale on mandibular posterior teeth. The main purpose of study is to evaluate the pain pre and post operatively following an Endodontic access cavity preparation. |