| CTRI Number |
CTRI/2025/03/082013 [Registered on: 07/03/2025] Trial Registered Prospectively |
| Last Modified On: |
05/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Testing whether baking soda makes numbing medicine work better for upper back tooth removal. |
|
Scientific Title of Study
|
Efficacy of Buffered Articaine in Maxillary Third Molar Extractions |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bandi Sandeep Paul |
| Designation |
Post Graduate |
| Affiliation |
SIBAR Institute of Dental Sciences |
| Address |
DEPATMENT OF ORAL AND MAXILLOFACIAL SURGERY, ROOM NO 3, GROUND FLOOR, SIBAR Institute of Dental Sciences, Takkellapadu, Guntur
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
7032340559 |
| Fax |
|
| Email |
sandeeppaulbandi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr MUSUNURI MANOJ KUMAR |
| Designation |
Associate Professor |
| Affiliation |
SIBAR Institute of Dental Sciences |
| Address |
DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY, ROOM NO 3, GROUND FLOOR,SIBAR Institute of Dental Sciences, Takkellapadu, Guntur
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
9959953010 |
| Fax |
|
| Email |
drmanojsurgery@sids.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Bandi Sandeep Paul |
| Designation |
Post Graduate |
| Affiliation |
SIBAR Institute of Dental Sciences |
| Address |
DEPARTMRNT OF ORAL AND MAXILLOFACIAL SURGERY, ROOM NO 3, GROUND FLOOR, SIBAR Institute of Dental Sciences, Takkellapadu, Guntur
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
7032340559 |
| Fax |
|
| Email |
sandeeppaulbandi@gmail.com |
|
|
Source of Monetary or Material Support
|
| SIBAR INSTITUTE OF DENTAL SCIENCES, TAKKELLAPADU, GUNTUR, ANDHRA PRADESH, INDIA
PINCODE - 522509 |
|
|
Primary Sponsor
|
| Name |
Bandi Sandeep Paul |
| Address |
Department of Oral and Maxillofacial Surgery, Sibar Institute of Dental Sciences, Takkellapadu, Guntur, Andhra pradesh, India, Pincode - 522509 |
| 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 Bandi Sandeep Paul |
Department of Oral and Maxillofacial Surgery |
DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY, ROOM NO 3, GROUND FLOOR,SIBAR Institute of Dental Sciences, Takkellapadu, Guntur
Guntur
ANDHRA PRADESH |
7032340559
sandeeppaulbandi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, SIBAR Institute of Dental Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K049||Other and unspecified diseases ofpulp and periapical tissues, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Articaine |
it will be administered by buccal infiltration (0.9ml) alone over 30 seconds for once and extraction was done |
| Intervention |
Buffered articaine |
it will be administered by buccal infiltration (0.9ml) over 30 seconds for once and extraction was done |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.ASA-I and ASA-II (American society of anaesthesiologists).
2.Patients with age group of 18-60 years.
3.Patients with acute inflammatory conditions requiring extractions of maxillary third molars.
4.Pell and Gregory class I.
|
|
| ExclusionCriteria |
| Details |
1.Presence of conditions that prevent dental extractions, like uncontrolled bleeding disorders.
2.Necessity of surgical access and bone removal (osteotomy) for maxillary molar surgery.
3.A record of allergies or negative reactions to articaine or similar local anaesthetics.
4.Pregnant and lactating women.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain at Injection Site, Onset of Anesthesia, Duration of Anesthesia, Post Extraction Pain |
Pain at Injection Site, Onset of Anesthesia, will be assessed immediately and Duration of Anesthesia, Post Extraction Pain after 3 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| any adverse reactions |
immediately and after extraction |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
24/03/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
A randomized double blind split mouth interventional study will be conducted with an aim to examine whether buffering articaine will help in terms of pain at injection site, onset of anesthesia, duration of anesthesia, post extraction pain. the objectives of the study were to assess the pain, onset of anesthesia, duration of anesthesia, and post extraction pain at the injection site of Articaine and Buffered Articaine groups. and to compare pain at the site of injection, onset of anesthesia, duration of anesthesia, and post extraction pain between Articaine and Buffered Articaine groups. A total of 52 patients reporting to the department of oral and maxillofacial surgery during the study period for maxillary third molar extractions will be selected based on inclusion and exclusion criteria Study will be explained and written informed consent will be obtained from the participants and patients will be randomly assigned to one of the two groups (Group-1 Articaine, Group-2 Buffered Articaine) by coin toss method. In Group 1 Articaine will be administered by buccal infiltration (0.9ml) alone and extraction was done and in Group 2 Buffered Articaine will be administered by buccal infiltration (0.9ml) and extraction was done and pain at injection and onset of anesthesia will be assessed immediately after injection and surgical procedure will be carried out by single surgeon later duration of anesthesia, post extraction pain will be assessed post operatively after 3 hours. Statistical analysis will be done using descriptive and inferential statistics that include Dependent t test / Wilcoxon signed rank test to compare variables between both the groups. |