| CTRI Number |
CTRI/2025/02/079995 [Registered on: 06/02/2025] Trial Registered Prospectively |
| Last Modified On: |
24/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Use of a mixture of local anaesthesia and sodium bicarbonate to reduce pain in oral surgery |
|
Scientific Title of Study
|
Comparative Evaluation of Efficacy Of Buffering of 2% Lignocaine Hydrochloride in Apicoectomy Procedure. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Manoj Bafna |
| Designation |
MDS Trainee |
| Affiliation |
DR D Y Patil Dental College And Hospital |
| Address |
Department of Oral and Maxillofacial Surgery, Dr. D.Y. Patil Dental College And Hospital, Sant Tukaram Nagar, pimpri, pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9176317008 |
| Fax |
|
| Email |
bafna7008@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Manoj Bafna |
| Designation |
MDS Trainee |
| Affiliation |
DR D Y Patil Dental College And Hospital |
| Address |
Department of Oral and Maxillofacial Surgery, Dr. D.Y. Patil Dental College And Hospital, Sant Tukaram Nagar, pimpri, pune
MAHARASHTRA
411018
India |
| Phone |
9176317008 |
| Fax |
|
| Email |
bafna7008@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Manoj Bafna |
| Designation |
MDS Trainee |
| Affiliation |
DR D Y Patil Dental College And Hospital |
| Address |
Department of Oral and Maxillofacial Surgery, Dr. D.Y. Patil Dental College And Hospital, Sant Tukaram Nagar, pimpri, pune
MAHARASHTRA
411018
India |
| Phone |
9176317008 |
| Fax |
|
| Email |
bafna7008@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Oral and Maxillofacial Surgery, Dr. D.Y. Patil Dental College And Hospital |
|
|
Primary Sponsor
|
| Name |
Department of Oral and Maxillofacial Surgery Dr DY Patil Dental College And Hospital |
| Address |
Sant Tukaram nagar
Pimpri,Pune |
| 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 Kalyani Bhate |
Dr D Y Patil Dental College And Hospital |
Department of Oral and Maxillofacial Surgery, Sant Tukaram Nagar, pimpri, pune
Pune
MAHARASHTRA |
9822099311
kalyani.bhate@dpu.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DR D.Y PATIL VIDYAPEETH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy volunteers requiring apicectomy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
BUFFERED LOCAL ANAESTHESIA |
2% Buffered lignocaine hydrochloride solution was prepared by mixing 10 ml of 2% lignocaine hydrochloride solution and 1 ml of 7.5% sodium bicarbonate solution at a ratio of 10:1. |
| Comparator Agent |
Non Buffered Local Anaesthesia |
2% LIGNOCAINE HYDROCHLORIDE WITH 1:200000 ADRENALINE |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with periapical infection requiring apicoectomy in maxillary anterior region
2. Patients between 18-60 years of age.
3. Willingness to participate |
|
| ExclusionCriteria |
| Details |
EXCLUSION CRITERIA
1. Patients with history of tobacco chewing, alcohol consumption and smoking.
2. Patient with any of the following medical conditions:
• Coagulation disorders
• Metabolic disorders
• Drug consumption leading to gingival hyperplasia
• Pregnancy
• History of radiotherapy, chemotherapy or having recently undergone any surgical procedures
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Pain
2. Discomfort score
3. Frequency of times of anaesthesia required
4. Amount of anaesthesia required
|
intraoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. Amount of anaesthesia required |
Intraoperatively |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
06/02/2025 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
Aim: The aim of this study is to evaluate and compare the efficacy
of buffering of 2% lignocaine hydrochloride in apicoectomy procedure
Materials and methods: A Randomised triple blinded study is designed where 24
patients were selected for this study. Twenty-four patients will be randomly
divided into group I and group II in equal numbers. In group I patients, 2% buffered
LA and in group II patients, unbuffered LA will be administered. Enucleation of
the cyst followed by apicoectomy procedure will be carried out in all the
patients. Pain and discomfort score intra-operatively will be assessed along
with number of times additional anaesthesia and amount of additional
anaesthesia required during the procedure will be noted in both the groups and compared
and evaluated.
Result : The collected data will be subjected to statistical analysis
with chi square test and independent sample t test. |