To compare the effectiveness of 2% Lidocaine Hydrochloride injection containing 1:100,000 Epinephrine administered as a single buccal infiltration versus conventional buccal and palatal infiltration during maxillary tooth extraction, using pain scores during injection and extraction as outcome measures.
Design
consecutive non-random sampling, single centre
Settings and conduct
armed Forces Institute of dentistry, CMH,Rawalpindi, pakistan
Participants/Inclusion and exclusion criteria
INCLUSION CRITERIA:
Patients presented to Oral and Maxillofacial surgery for any maxillary tooth removal for reasons like non-restorable tooth due to extensive caries or periodontal disease or for orthodontic extractions and assessed as suitable for removal under local anaesthesia.
2. Patients between the age of 18 and 45 years who were fit for the procedure. 3. Either gender.
4.Patients having physical status 1 according to American Society of Anesthesiologists (ASA) classification.
EXCLUSION CRITERIA:
1. Pregnant women, nursing mothers.
2. Patient with non-localized odontogenic infection.
3. Tooth associated with pathologies i.e. cysts, fractures, tumors.
4. Patients on radiotherapy, chemotherapy, bisphosphonates, bone diseases e.g. Paget’s disease.
Intervention groups
two intervention groups:
Group A — received a single buccal infiltration only (2 mL, 2% lidocaine HCl with 1:100,000 epinephrine)
Group B — received the conventional buccal + palatal infiltration (1.75 mL buccal + 0.25 mL palatal, same anesthetic)
Main outcome variables
Primary outcome: pain intensity (VAS score) measured after local anesthetic injection and after tooth extraction.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230714058773N6
Registration date:2026-08-06, 1405/05/15
Registration timing:retrospective
Last update:2026-08-06, 1405/05/15
Update count:0
Registration date
2026-08-06, 1405/05/15
Registrant information
Name
Tehmina Maryam
Name of organization / entity
Armed forces institute of dentistry, combined military hospital, Rawalpindi, Pakistan
Country
Pakistan
Phone
+92 333 9576737
Email address
tehminamaryam@hotmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-20, 1402/12/01
Expected recruitment end date
2024-08-20, 1403/05/30
Actual recruitment start date
2024-02-20, 1402/12/01
Actual recruitment end date
2024-08-20, 1403/05/30
Trial completion date
2024-08-20, 1403/05/30
Scientific title
Comparison of Single Buccal Infiltration Versus Conventional Buccal and Palatal Infiltration for Maxillary Tooth Extraction
Public title
Comparison of Single Buccal Infiltration Versus Conventional Buccal and Palatal Infiltration for Maxillary Tooth Extraction
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients presented to Oral and Maxillofacial surgery for any maxillary tooth removal for reasons like non-restorable tooth due to extensive caries or periodontal disease or for orthodontic extractions and assessed as suitable for removal under local anaesthesia.
Patients between the age of 18 and 45 years who were fit for the procedure.
Either gender.
Patients having physical status 1 according to American Society of Anesthesiologists (ASA) classification.
Exclusion criteria:
Pregnant women, nursing mothers.
Patient with non-localized odontogenic infection.
Tooth associated with pathologies i.e. cysts, fractures, tumors.
Patients on radiotherapy, chemotherapy, bisphosphonates, bone diseases e.g. Paget’s disease
Age
From 18 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
260
Actual sample size reached:
260
Randomization (investigator's opinion)
Randomized
Randomization description
Patients meeting the inclusion criteria were randomised into Group A (single buccal infiltration) or Group B (conventional buccal and palatal infiltration) using the lottery method. Equal numbers of folded paper chits marked "A" and "B" were prepared, corresponding to the total planned sample size, and placed in a sealed opaque container. At the time of enrolment, after the patient had provided informed consent, one chit was drawn by a staff member not involved in performing the extraction, and the patient was allocated to the group indicated on the chit. Each chit was discarded after use so that it could not be redrawn, ensuring that every patient had an equal and independent chance of allocation to either group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Armed Forces Institute of Dentistry, Combined Military Hospital, Rawalpindi
Street address
Armed Forces Institute of Dentistry, Combined Military Hospital, Rawalpindi
City
Rawalpindi
Postal code
46000
Approval date
2024-02-15, 1402/11/26
Ethics committee reference number
905/Trg-ABP1K2
Health conditions studied
1
Description of health condition studied
Need for maxillary tooth extraction (due to non-restorable caries, periodontal disease, or orthodontic indication)
ICD-10 code
maxillary
ICD-10 code description
maxillary tooth extraction
Primary outcomes
1
Description
Pain
Timepoint
10 minutes after injection and immediately after extraction
Method of measurement
visual analog scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: single buccal infiltration (2 mL, 2% lidocaine HCl with 1:100,000 epinephrine)
Category
Other
2
Description
Control group: conventional buccal + palatal infiltration (1.75 mL buccal + 0.25 mL palatal, same anesthetic)
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Armed Forces Institute of Dentistry, Combined Military Hospital, Rawalpindi
Full name of responsible person
Dr Tehmina Maryam
Street address
Armed Forces Institute of Dentistry, Combined Military Hospital, Rawalpindi
City
Rawalpindi
Postal code
46000
Phone
+92 333 9576737
Email
tehminamaryam27@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Armed Forces Institute of Dentistry. Combined Military Hospital, Rawalpindi
Full name of responsible person
Dr Raeha Nadeem
Street address
Armed Forces Institute of Dentistry, Combined Military Hospital, Rawalpindi
City
Rawalpindi
Postal code
46000
Phone
+92 333 9576737
Email
tehminamaryam27@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Armed Forces Institute of Dentistry. Combined Military Hospital, Rawalpindi
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Armed Forces Institute of Dentistry. Combined Military Hospital, Rawalpindi
Full name of responsible person
Dr Tehmina Maryam
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Oral and Maxillofacial Surgery
Street address
Armed Forces Institute of Dentistry, Combined Military Hospital, Rawalpindi
City
Rawalpindi
Province
punjab
Postal code
46000
Phone
+92 333 9576737
Email
tehminamaryam27@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Armed Forces Institute of Dentistry. Combined Military Hospital, Rawalpindi
Full name of responsible person
Dr Tehmina Maryam
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
oral and maxillofacial surgery
Street address
Armed Forces Institute of Dentistry, Combined Military Hospital, Rawalpindi
City
Rawalpindi
Province
punjab
Postal code
46000
Phone
+92 333 9576737
Email
tehminamaryam27@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Armed Forces Institute of Dentistry. Combined Military Hospital, Rawalpindi
Full name of responsible person
Dr Noman Tahir
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Armed Forces Institute of Dentistry, Combined Military Hospital, Rawalpindi
City
Rawalpindi
Province
punjab
Postal code
46000
Phone
+92 333 9576737
Email
tehminamaryam27@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Comparison of Single Buccal Infiltration Versus Conventional Buccal and Palatal Infiltration for Maxillary Tooth Extraction
When the data will become available and for how long
after publication for good
To whom data/document is available
everyone
Under which criteria data/document could be used
everyone
From where data/document is obtainable
tehminamaryam27@gmail.com
What processes are involved for a request to access data/document
Researchers interested in accessing the de-identified dataset and/or data collection forms may submit a written request to the corresponding author, along with a brief description of the intended use. Requests will be reviewed and, upon approval from the Department of Oral and Maxillofacial Surgery, AFID Rawalpindi, the relevant data will be shared within few weeks of the request. Data will be provided in pdf file and will exclude any patient-identifying information in line with the informed consent obtained from participants.