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CTRI Number  CTRI/2026/01/102317 [Registered on: 28/01/2026] Trial Registered Prospectively
Last Modified On: 21/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia
Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison and evaluation of pain during local anesthesia administration of buffered and non buffered 2 percent lignociane 
Scientific Title of Study   Comparative evaluation of pain perception during administration of buffered and non-buffered 2 percent Lignocaine local anesthesia in pediatric patients aged 7-9 years -A Split-mouth Randomized Controlled Trial 
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 Pranit Lunavat 
Designation  PG Student 
Affiliation  MGVs KBH Dental College and Hospital 
Address  201, Department of Pediatric and Preventive Dentistry, MGVs KBH Dental College and Hospital, Panchavati

Nashik
MAHARASHTRA
422003
India 
Phone  7770088004  
Fax    
Email  lunavatpranit@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Pranit Lunavat 
Designation  PG Student 
Affiliation  MGVs KBH Dental College and Hospital 
Address  201, Department of Pediatric and Preventive Dentistry, MGVs KBH Dental College and Hospital, Panchavati


MAHARASHTRA
422003
India 
Phone  7770088004  
Fax    
Email  lunavatpranit@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Bhushan Pustake 
Designation  Professor 
Affiliation  MGVs KBH Dental College and Hospital 
Address  201, Department of Pediatric and Preventive Dentistry, MGVs KBH Dental College and Hospital, Panchavati

Nashik
MAHARASHTRA
422003
India 
Phone  9823191640  
Fax    
Email  pustakeb@gmail.com  
 
Source of Monetary or Material Support  
MGVs KBH Dental College and Hospital,Panchavati, Nashik, Maharashtra, India 422003 
 
Primary Sponsor  
Name  MGVs KBH Dental College and Hospital,Nashik 
Address  201, Department of Pediatric and Preventive Dentistry, MGVs KBH Dental College and Hospital, Panchavati, Nashik 422003 
Type of Sponsor  Other [Dental College] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Pranit Lunavat  MGVs KBH Dental College and Hospital, Nashik  201, Department of Pediatric and Preventive Dentistry, MGVs KBH Dental College and Hospital,Panchavati
Nashik
MAHARASHTRA 		 7770088004

lunavatpranit@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KBH Dental College Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Dental ailments 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Buffered 2 percent Lignocaine local anesthesia  Addition of 0.1ml Sodium bicarbonate solution 2 percent lignocaine local anesthesia injection,nerve block anestheisa and infiltration anesthesis 
Comparator Agent  Non-buffered 2 percent Lignocaine local anesthesia  2 percent Lignocaine local anesthesia, nerve block anestheisa and infiltration anesthesis 
 
Inclusion Criteria  
Age From  7.00 Year(s)
Age To  9.00 Year(s)
Gender  Both 
Details  1. Patients aged 7-9 years requiring dental treatment under local anesthesia.
2. Patient with no prior history of local anesthesia administration for dental treatment procedure.
3. Co-operative behavior for dental treatment under local anesthesia (class 3 or 4 in Frankel scale).
4. No difficulties in communication.
 
 
ExclusionCriteria 
Details  1. Allergic reactions to local anesthesia or sulfites and sodium bicarbonate.
2. Children who require emergency dental treatment.
3. History of significant medical conditions, cardiac conditions, hemophilia, etc.
4. Evidence of soft tissue infection/inflammation near the area of injection.
5. Taking any medication that potentially interferes with pain assessment within 24 hours before the treatment.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1. To evaluate pain perception during administration of buffered 2 percent Lignocaine local anesthesia and non-buffered 2 percent Lignocaine local anesthesia in pediatric patients aged 7-9 years undergoing dental treatment by using Wong Bakers FACES Pain Rating Scale.


2. To compare the difference between pain perception during administration of buffered 2 percent Lignocaine local anesthesia and non-buffered 2 percent Lignocaine local anesthesia in pediatric patients aged 7-9 years.
 		 At the time on dilivery of injection (baseline) 
 
Secondary Outcome  
Outcome  TimePoints 
NIL   
 
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)   02/02/2026 
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 Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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  

Pain is defined as an unpleasant sensory and emotional experience with actual or potential tissue damage. The management of pain is a crucial factor in dentistry since it dictates the behavior of patient during the present appointment as well as ensure compliance for future visits. In dentistry, the employment of local anesthesia as a means of pain control has been one of the medical marvels.

Local anesthesia poses a wide range of its use in the field of dentistry for adequate control of pain producing long-term blockade of the sensory nerve and subsequently minimizes the requirement of analgesics after any dental procedures.

One of the major issue after administering a local anesthetic solution is pain/ burning sensation on injection. This is mainly due to acidic pH of commercially available local anesthetic solutions. The pH of a commercially available local anesthetic solution has to be acidic to maximize stability in solution and shelf-life.

Several ways to decrease the pain/discomfort of local anesthetic administration include topical local anesthesia, use of thin needle, slow injection, injecting during needle withdrawal and altering the temperature of anesthetic solution.

Buffering or alkalization of lignocaine with sodium bicarbonate (pH 7-8.5) just before its administration is also mentioned in the literature as another means to reduce discomforts associated with LA injection.

The addition of sodium bicarbonate as a buffering agent to local anesthetics increases the pH of the solution and also result in the production of carbon dioxide and water. Condouris et al. reported that carbon dioxide potentiated the action of local anesthetics by showing that in the presence of carbon dioxide, nerve conduction blockade was significantly greater than in its absence.

The only drawback with adoption of this technique is that the buffered lignocaine solutions are relatively unstable. Hence, on-spot fresh preparation of buffered solution is required which may lead to increase in treatment time and makes it less applicable at the time of emergencies. This study can open new avenues for painless dental treatment.

Rationale:

Pain and discomfort caused during administration of LA has been attributed to many factors, including the size of needle, site and speed of injection, any localized inflammation, and low pH of the anesthetic solution.

The demand for a less painful, faster onset and effective potency of anesthetic solution is a great concern for pediatric dentists to maintain the cooperation of the children on dental chair.

Buffered anesthetic solutions create pH after injection nearly close to that of the normal tissue pH resulting in more rapid drug diffusion and a quicker onset of the nerve blocking as well as less painful experience during injection.

Addition of Sodium bicarbonate in local anesthesia have been proven method for buffering the acidic nature of local anesthesia which in-turn reduces the pain/ discomfort by increasing the pH of anesthetic solution. There are very few studies regarding this on pediatric population in India. The purpose of this study is to determine the most effective method to reduce pain perception during administration of local anesthesia in pediatric patient.

Primary Research Question

Is there any difference in pain perception during administration of buffered (7.5 percent Sodium bicarbonate with 2 percent  Lignocaine with 1:80000 Adrenaline) Local Anesthesia as compared to non-buffered (2 percent Lignocaine with 1:80000 Adrenaline) Local Anesthesia in pediatric patients aged 7-9 years?

Method of Measurement:

Pain experience by children will be evaluated by Wong Bakers FACES Pain Rating Scale during administration of local anesthetic solution using two different injection solution. This scale will be used for the subjective assessment or magnitude of the pain felt by children. The child will be shown a set of six cartoon faces with varying facial expressions ranging from a smile, laughter and/or tears. Each face has an assigned numerical value from 0 to 10.

IX) Data Collection Tools:

1.      Wong Bakers FACES Pain Rating Scale.

X) Methods of data collection:

This study will be conducted in the Department of Pedodontics and Preventive Dentistry. The study will be conducted in children of age group of 7 to 9 years.

1.      After comfortably seating the patient on dental chair, the procedure will be explained to the parent as well as the children.

2.      In all patients, thorough history, clinical examination and preoperative radiographs will be taken.

3.      60 children fulfilling inclusion and exclusion criteria requiring dental procedures under local anesthesia. This study will be conducted using two different injection solution in the children in different appointments such that each child will serve as his or her own control.

4.      This will a split mouth study- (buffered and non-buffered LA in two different sides in same patient).

5.      Side 1- 7.5 percent Sodium bicarbonate buffered Local Anesthesia 2 percent Lignocaine with 1:80000 Adrenaline.

6.      Side 2- Local Anesthesia 2 percent Lignocaine with 1:80000 Adrenaline.

7.      Treatment will be carried by operator (Pediatric Dentist). Pain perception scoring by Wong Bakers FACES Pain Rating Scale will be recorded by patient.

XI) Data Management and analysis procedure:

Statistical analysis will be performed using Statistical Product and Service Solution (SPSS) version 21 for Windows (SPSSInc, Chicago, IL).

Descriptive statistics for ordinal qualitative data will be expressed in frequency and percentage respectively.

Descriptive statistics for continuous qualitative data will be expressed in mean and standard deviation respectively.

XII) Data analysis plan and method:

Intergroup comparison between both groups in respect to qualitative study parameters will be done using Chi square test.

Confidence interval is set at 95 percent and probability of alpha error (level of significance) set at 5 percent. Power of the study set at 80 percent.

XIII) Research in AYUSH:

Not Applicable

XIV)Additional points for RCT:

1.      Randomization proposed: Simple random sampling technique by using coin toss method.

2.      Allocation concealment proposed: It will be done by SNOSE technique. Sequentially numbered opaque sealed envelopes (SNOSE) will be prepared for each sample. Group allocation number will be mentioned in each envelop. Envelopes will be prepared by a person who is not aware of the study and after random allocation, these envelopes will be opened by operator just before intervention.

3.      Blinding proposed: Single blinding (Blinding would be done to patient).

XV)Method of Intervention:

Two different injection solution are used for administration of local anesthesia are as follows-

1.      Buffered Local anesthesia- 7.5 percent Sodium bicarbonate in 2 percent lignocaine with 1:80000 Adrenaline (1:10)

2.      Non-buffered Local Anesthesia- 2 percent lignocaine with 1:80000 Adrenaline

Pain perception will be assessed using Wong Bakers FACES Pain Rating Scale.



 
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