Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000946415
Ethics application status
Approved
Date submitted
2/07/2025
Date registered
29/08/2025
Date last updated
29/08/2025
Date data sharing statement initially provided
29/08/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparative efficacy of transpapillary injection and palatal infiltration techniques for dental extraction in pediatric patients.
Scientific title
Comparative efficacy of transpapillary injection and palatal infiltration techniques for dental extraction in pediatric patients.
Secondary ID [1] 314789 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dental Anaesthesia 338031 0
Dental Extractions 338317 0
Condition category
Condition code
Oral and Gastrointestinal 334336 334336 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Anaesthesiology 335005 335005 0 0
Other anaesthesiology
Anaesthesiology 335006 335006 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
For Group 1, the Transpapillary Injection (TPI) technique will be employed. In this method, the local anesthetic solution (0.3-0.4ml) is administered through the papilla adjacent to the tooth being extracted, with a needle is inserted perpendicularly through the papillary tissue. This approach aims to achieve effective anesthesia with minimal discomfort to the patient.
Standard dental cartridge syringe with 27G needle (25mm in length) and 2% lignocaine with epinephrine (1:100,000) local anaesthesia solution will be used.
Researcher or co-researchers who are practicing oral surgeons will administer the anesthesia to the patients.
Intervention code [1] 331390 0
Treatment: Surgery
Comparator / control treatment
For Group 2, the Palatal Infiltration (PI) technique will be used. Here, the local anesthetic solution (0.2-0.3ml) is injected directly into the palatal tissue near the site of extraction. The needle is positioned at a 90-degree angle to the palate, ensuring that the anesthetic reaches the dense palatal mucosa, providing effective anesthesia for maxillary procedures.
Standard dental cartridge syringe with 27G needle (25mm in length) and 2% lignocaine with epinephrine (1:100,000) local anaesthesia solution will be used.
Researcher or co-researchers who are practicing oral surgeons will administer the anesthesia to the patients.
Control group
Active

Outcomes
Primary outcome [1] 342023 0
Patient-Reported Pain
Timepoint [1] 342023 0
immediately at the end of whole procedure
Secondary outcome [1] 449348 0
Onset of action of local anesthesia
Timepoint [1] 449348 0
Subjective: Initial report of numbness by the patient or 2 mins after the application of anesthesia (whichever comes first) Objective: Dental explorer in palatal gingival sulcus
Secondary outcome [2] 449349 0
Duration of action
Timepoint [2] 449349 0
Subjective: Initial report of return of sensation by the patient or one hour after the application of anesthesia. (whichever comes first) Objective: Dental explorer in palatal gingival sulcus

Eligibility
Key inclusion criteria
Patient requiring extraction of maxillary teeth.
Patients in mixed dentition stage (6-13 years).
Medically healthy patients.
Minimum age
6 Years
Maximum age
13 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Acute localized infection (cellulitis or abscess)
patients with behavioural issues like Attention deficit hyperactivity disorder (ADHD), cerebral palsy, slow learners like Down's syndrome, crouzon syndrome etc.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation to each group was done by coin toss.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocation to each group was done by coin toss and sequence was generated accordingly as soon as the patients were recruited in the study.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A total of 68 participants will be selected using simple random sampling from a population of 100, with a 95% confidence level, an anticipated population proportion of 0.05, an absolute precision of 0.03, and a relative precision of 0.6. The participants will be divided equally into two groups, with 34 participants in each group.
Data will be analyzed using SPSS 25 version. Frequency and percentages will be calculated for categorical variables like gender while Mean±S.D will be calculated for continuous variables like age, pain score (VAS) time of onset and duration of action (in mins). Independent samples t test will be used to compare the outcomes of continuous variables.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2025
Actual
Date of last participant enrolment
Anticipated
31/10/2025
Actual
Date of last data collection
Anticipated
31/10/2025
Actual
Sample size
Target
68
Accrual to date
Final
Recruitment outside Australia
Country [1] 27168 0
Pakistan
State/province [1] 27168 0
Punjab

Funding & Sponsors
Funding source category [1] 319344 0
Self funded/Unfunded
Name [1] 319344 0
Country [1] 319344 0
Primary sponsor type
Individual
Name
Dr. Meher Moin Khan. Watim Medical and Dental College, Rawalpindi
Address
Country
Pakistan
Secondary sponsor category [1] 321835 0
Individual
Name [1] 321835 0
Dr.Eruj Shuja Bashir Institute of Health Sciences, Islamabad
Address [1] 321835 0
Country [1] 321835 0
Pakistan

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317925 0
Ethical Approval Committee, Watim Medical College Rawalpindi (WMCR)
Ethics committee address [1] 317925 0
Ethics committee country [1] 317925 0
Pakistan
Date submitted for ethics approval [1] 317925 0
04/12/2023
Approval date [1] 317925 0
15/01/2024
Ethics approval number [1] 317925 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 142578 0
Ms Eruj Shuja
Address 142578 0
Bashir Institute of Health Sciences Bhara Kahu Spring Valley Society Islamabad
Country 142578 0
Pakistan
Phone 142578 0
+923315532639
Fax 142578 0
Email 142578 0
[email protected]
Contact person for public queries
Name 142579 0
Muhammad Adil Asim
Address 142579 0
Faculty of Dentistry, Building no 12 University district Najran
Country 142579 0
Saudi Arabia
Phone 142579 0
+966537985134
Fax 142579 0
Email 142579 0
[email protected]
Contact person for scientific queries
Name 142580 0
Muhammad Adil Asim
Address 142580 0
Faculty of Dentistry, Building no 12 University district Najran
Country 142580 0
Saudi Arabia
Phone 142580 0
+966537985134
Fax 142580 0
Email 142580 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: As its an interventional study including paediatric patients, for ethical considerations the individual patient details cannot be shared.



What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.