| CTRI Number |
CTRI/2025/03/082187 [Registered on: 12/03/2025] Trial Registered Prospectively |
| Last Modified On: |
06/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
effect of adding alkaline agent to local anesthetic solution and checking its effect on pain perception and discomfort in children. |
|
Scientific Title of Study
|
Effect of buffered vs non-buffered local anesthetic solution on pain perception and onset of anesthesia in children. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Harsha Kewlani |
| Designation |
Part 3 Post gruduate student |
| Affiliation |
College of Dental sciences and research centre, Bopal |
| Address |
2nd floor, department of pediatric and preventive dentistry, College of dental sciences and research centre Near navneet printing press, opposite pleasure club, bopal, ahmedabad Ahmadabad GUJARAT
2nd floor, department of pediatric and preventive dentistry, College of dental sciences and research centre Near navneet printing press, opposite pleasure club, bopal, ahmedabad Ahmadabad GUJARAT
Ahmadabad
GUJARAT
382115
India |
| Phone |
9023999594 |
| Fax |
|
| Email |
harshakewlani28@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Harsha Kewlani |
| Designation |
Part 3 Post gruduate student |
| Affiliation |
College of Dental sciences and research centre, Bopal |
| Address |
2nd floor, Department if pediatric and preventive dentistry, College of dental sciences and research centre Near navneet printing press, opposite pleasure club, bopal, ahmedabad Ahmadabad GUJARAT
2nd floor, Department if pediatric and preventive dentistry, College of dental sciences and research centre Near navneet printing press, opposite pleasure club, bopal, ahmedabad Ahmadabad GUJARAT
Ahmadabad
GUJARAT
382115
India |
| Phone |
9023999594 |
| Fax |
|
| Email |
harshakewlani28@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Harsha Kewlani |
| Designation |
Part 3 Post gruduate student |
| Affiliation |
College of Dental sciences and research centre, Bopal |
| Address |
2nd floor, department of pediatric and preventive dentistry, College of dental sciences and research centre Near navneet printing press, opposite pleasure club, bopal, ahmedabad Ahmadabad GUJARAT
2nd floor, department of pediatric and preventive dentistry, College of dental sciences and research centre Near navneet printing press, opposite pleasure club, bopal, ahmedabad Ahmadabad GUJARAT
Ahmadabad
GUJARAT
382115
India |
| Phone |
9023999594 |
| Fax |
|
| Email |
harshakewlani28@gmail.com |
|
|
Source of Monetary or Material Support
|
| College of dental sciences and research centre, Bopal, 382115 Ahmedabad, India |
|
|
Primary Sponsor
|
| Name |
Self College of dental sciences and research centre |
| Address |
College of dental sciences and research centre Near navneet printing press, opposite pleasure club, bopal, ahmedabad Ahmadabad GUJARAT |
| 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 Harsha Kewlani |
College of dental sciences and research centre |
2nd floor, department of pediatric and preventive dentistry, CDSRC, Near navneet printing press, opposite pleasure club, bopal, ahmedabad
Ahmadabad
GUJARAT |
09023999594
harshakewlani28@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical commitee college of dental sciences and research centre |
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 |
Buffered lignocaine |
2% lignocaine buffered with 8.4 % sodium bicarbonate used on same day, administered not more than 4.4 mg/dl per kg per patient and then the solution is discarded and every time newly made. |
| Comparator Agent |
Lignocaine |
2% lignocaine available in market |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
patients between 6-10 years of age who had not undergone any prior dental treatment, requiring bilateral IANB and exhibited Frankl behavior rating grade 3 or 4
|
|
| ExclusionCriteria |
| Details |
Patients who were allergic to local anesthesia;
had medically-compromised condition or,
History of dental treatment
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain perception and time of onset of anesthesia |
Same day , 1 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| efficacy of analgesia |
same day, after 1 week |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
17/03/2025 |
| 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="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Introduction
Dental anxiety and fear of needle injection is one of
the most common problems encountered by dental practitioners, especially in the
pediatric patient. Several methods are suggested to lower the discomfort of
local anesthesia injection during dental procedures. There are some technical
advances to lower the pain of injection by alkalization of dental anesthetics
prior to injection.
Aim:
This study aims to evaluate the efficacy of pH
buffering of local anesthetic drug, on the pain,discomfort and onset of local
anesthesia injection during dental procedures. Children divided randomly in 2 groups- Test group and
Control Group Group 1 – Test group-The test solution -alkalinized 2% lidocaine/
epinephrine 1:100,000 is administered before the dental treatment. Group 2- Control group- non-alkalinized 2% lidocaine/epinephrine 1:100,000 is administered
before the dental treatment.
Pain perception
during the administration of local anesthesia, the time of onset and efficacy of analgesia assessed. |