| CTRI Number |
CTRI/2020/02/023525 [Registered on: 24/02/2020] Trial Registered Prospectively |
| Last Modified On: |
21/02/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
comparison of pain on injection and onset of anaesthesia of 2% buffered lidocaine with adrenaline and 2% non-buffered lidocaine with adrenaline in inferior alveolar nerve block for primary molars- a randomized double blind study |
|
Scientific Title of Study
|
COMPARISON OF PAIN ON INJECTION AND ONSET OF ANESTHESIA OF 2 % BUFFERED LIDOCAINE (WITH 1 :2,00,000 ADRENALINE) AND 2 % NONBUFFERED LIDOCAINE (WITH 1:2,00,000 ADRENALINE) IN INFERIOR ALVEOLAR NERVE BLOCK FOR PRIMARY MOLARS: A RANDOMIZED DOUBLE BLIND 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 Shrawani Mankar |
| Designation |
P.G. student |
| Affiliation |
V.S.P.M.s Dental College and Research Centre, Nagpur |
| Address |
dept no- 301, dept of pediatric and preventive dentistry, V.S.P.M. Dental college and Research Centre, digdoh hills, hingna Road, Nagpur
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9970032254 |
| Fax |
|
| Email |
drshrawani5@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Devendra Nagpal |
| Designation |
Professor & Head |
| Affiliation |
V.S.P.M.s Dental College and Research Centre, Nagpur |
| Address |
dept no- 301, dept of pediatric and preventive dentistry, V.S.P.M. Dental college and Research Centre, digdoh hills, hingna Road, Nagpur
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9764271839 |
| Fax |
|
| Email |
drdevendra19@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shrawani Mankar |
| Designation |
P.G. student |
| Affiliation |
V.S.P.M.s Dental College and Research Centre, Nagpur |
| Address |
dept no- 301, dept of pediatric and preventive dentistry, V.S.P.M. Dental college and Research Centre, digdoh hills, hingna Road, Nagpur
MAHARASHTRA
440019
India |
| Phone |
9970032254 |
| Fax |
|
| Email |
drshrawani5@gmail.com |
|
|
Source of Monetary or Material Support
|
| V.S.P.M. Dental college and Research Centre, Nagpur |
|
|
Primary Sponsor
|
| Name |
Dr Shrawani Mankar |
| Address |
dept no- 301, dept of pediatric and preventive dentistry, V.S.P.M. Dental college and Research Centre, digdoh hills, hingna Road, Nagpur |
| 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 Shrawani Mankar |
V.S.P.M. Dental college and Research Centre, Nagpur |
dept no- 301, dept of pediatric and preventive dentistry.
Nagpur
MAHARASHTRA |
9970032254
drshrawani5@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Of V.S.P.M. Dental college and Research Centre. |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
primary molars indicated for atleast two clinical sessions of dental procedures requiring inferior alveolar nerve block |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
2% buffered lidocaine [with 1:2,00,000 adrenaline] |
buffered lidocaine increases the pH of commercially available lidocaine [with 1:2,00,000 adrenaline] thus reducing pain during administration of local anesthesia and also hastens the onset of anaesthesia |
| Comparator Agent |
2% lidocaine [with 1:2,00,000 adrenaline] |
2% lidocaine [with 1:2,00,000 adrenaline] is most frequently used local anaesthetic used in dentistry with acidic pH |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
healthy children indicated for atleast two similar clinical sessions of dental procedures requiring inferior alveolar nerve block and exhibiting Frankls behaviour rating score 3 or 4 |
|
| ExclusionCriteria |
| Details |
children with known history of allergy to any local anesthetic agent, active infection at the site if injection, history of dental treatment in last 6 months. |
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| pain on injection and onset of anesthesia |
after administration of local anesthesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| not applicable |
not applicable |
|
|
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)
|
25/02/2020 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Reduction in pain is one of the most important aspects of behaviour management in children undergoing dental treatment. Local anaesthesia administration is a prerequisite for pain reduction while performing various restorative, endodontic and minor surgical procedures in children. Inferior alveolar nerve block (IAN) is the most routinely used injection technique for achieving local anaesthesia for endodontic treatment of mandibular teeth. Pain caused during local anaesthesia administration has been attributed to many factors, including the speed of injection, site of injection, and pH of the anaesthetic solution. Lidocaine is the most frequently used local anaesthetic (LA). It contains a vasoconstrictor and an antioxidant to prevent early oxidation of vasoconstrictor and increase the shelf life. This leads to low ph ranging from 2.9 and 4.4 which may produce a burning sensation on the injection site, a slower onset of anaesthesia and a decrease in its clinical efficacy. It has been suggested that alkalizing this acidic solution can reduce pain caused during administration of local anaesthesia. This also hastens the onset of anaesthesia by increasing the concentration of uncharged basic form and facilitating the penetration of lidocaine into the nerve cell. The addition of sodium bicarbonate to LA also result in the production of carbon dioxide and water. Carbon dioxide potentiates local anaesthesia by 3 mechanisms. Firstly by having direct depressant effect on the axon. Secondly by concentrating LA inside the nerve trunk and lastly by converting LA to the active cation through its effect on pH at the site of action inside the nerve. Studies have been conducted to assess the use of buffered lidocaine for infiltration and block anaesthesia during dental procedures in adults, but literature on the use of buffered lidocaine solution in children is sparse. The purpose of study is to compare pain on injection and onset of anaesthesia of 2 % buffered lidocaine(with 1 :2,00,000 adrenaline) and 2 % nonbuffered lidocaine (with 1:2,00,000 adrenaline) in inferior alveolar nerve block for primary molars: a randomized double blind study. This study was planned with hypothesis that there is a significant difference in pain on injection and onset of anaesthesia of 2% buffered lidocaine (with 1:2,00,000 adrenaline) and 2% nonbuffered lidocaine (with 1:2,00,000 adrenaline) in inferior alveolar nerve block for primary molars |