| CTRI Number |
CTRI/2024/11/077488 [Registered on: 29/11/2024] Trial Registered Prospectively |
| Last Modified On: |
20/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing two injection techniques in palatal anesthesia for painless removal of upper back milk teeth |
|
Scientific Title of Study
|
Anesthetic effectiveness of trans-papillary injection and conventional palatal injection technique in children of age 7-10 year – A 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 Arun CS |
| Designation |
Post-Graduate Resident |
| Affiliation |
Government Dental College, Kottayam |
| Address |
Department of Pediatric and Preventive Dentistry,
Government Dental College,
Kottayam,
Kerala.
Kottayam
KERALA
686008
India |
| Phone |
7909146070 |
| Fax |
|
| Email |
aruncs2310@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kannan VP |
| Designation |
Professor and Head of the Department |
| Affiliation |
Government Dental College, Kottayam |
| Address |
Department of Pediatric and Preventive Dentistry,
Government Dental College,
Kottayam,
Kerala.
Kottayam
KERALA
686008
India |
| Phone |
9446506755 |
| Fax |
|
| Email |
kannanpedo@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kannan VP |
| Designation |
Professor and Head of the Department |
| Affiliation |
Government Dental College, Kottayam |
| Address |
Department of Pediatric and Preventive Dentistry,
Government Dental College,
Kottayam,
Kerala.
Kottayam
KERALA
686008
India |
| Phone |
9446506755 |
| Fax |
|
| Email |
kannanpedo@gmail.com |
|
|
Source of Monetary or Material Support
|
| Deparment of Pediatric and Preventive Dentistry, Government Dental College Kottayam, Gandhinagar PO, Kottayam, Kerala, India 686008 |
|
|
Primary Sponsor
|
| Name |
Dr Arun CS |
| Address |
Department of Pediatric and Preventive Dentistry,
Government Dental College,
Kottayam,
Kerala,
Pin code- 686008 |
| 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 Arun CS |
GOVERNMENT DENTAL COLLEGE, KOTTAYAM |
Room no 711, PG Clinic, Department of Pediatric and Preventive Dentistry,
Government Dental College,
Kottayam,
Kerala- 686008.
Kottayam
KERALA |
7909146070
aruncs2310@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC)/ Institutional Review Board (IRB) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K041||Necrosis of pulp, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Palatal injection technique |
The buccal mucosa will be wiped and dried with sterile dry cotton followed by application of 20% benzocaine topical gel (SEPTODONT PROGEL-B) with the help of Q tip. After 10 seconds patient will be injected with 2% lignocaine hydrochloride with 1:200000 adrenaline with a help of 27G needle of 15mm length. A 2ml syringe will be used for both the techniques. Then 1.0 ml of solution will be injected into the buccal sulcus after which 0.5ml of anesthetic solution will be injected in the palatal region of the respective tooth to be extracted after 2 minutes of buccal infiltration. |
| Intervention |
Trans-papillary injection technique |
The buccal mucosa will be wiped and dried with sterile dry cotton followed by application of 20% benzocaine topical gel (SEPTODONT PROGEL-B) with the help of Q tip. After 10 seconds patient will be injected with 2% lignocaine hydrochloride with 1:200000 adrenaline with a help of 27G needle of 15mm length. A 2ml syringe will be used for both the techniques.
Then 1.0 ml of solution will be injected into the buccal sulcus after which 0.5ml of anesthetic solution will be injected in the inter papillary region of the respective tooth to be extracted after 2 minutes of buccal infiltration.for each patient approximately 30 to 45 seconds will be required to administer the transpapillary injection, the effect of the anaesthetic will last for a duration of 2 hour
|
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
Children who needs primary maxillary molar extraction. Children under ASA I and II category.
|
|
| ExclusionCriteria |
| Details |
Children who reported with allergy or hypersensitivity to local anesthetics or any ingredients in anesthetic solution. Children under CNS depressants.
Children not willing to participate in the study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Accessing pain experienced during administration and after extraction of the tooth by FAS and VAS scales |
At baseline, immediately after local anesthetic administration and post-extraction of the tooth. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessing anxiety via QUESTIONNAIRE, PULSE RATE, & SpO2 after the extraction of the tooth by conventional palatal technique |
At baseline, before & after extraction period |
| Assessing anxiety via QUESTIONNAIRE, PULSE RATE, & SpO2 after the extraction of the tooth by trans-papillary injection technique. |
At baseline, before & after extraction period |
| Comparison of anxiety between conventional palatal technique & trans-papillary injection technique. |
At baseline, before & after extraction period |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/08/2025 |
| Date of Study Completion (India) |
18/01/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The buccal mucosa will be wiped and dried with sterile dry cotton followed by application of 20% benzocaine topical gel (SEPTODONT PROGEL-B) with the help of Q tip. After 10 seconds patient will be injected with 2% lignocaine hydrochloride with 1:200000 adrenaline with a help of 27G needle of 15mm length. A 2ml syringe will be used for both the techniques. Then 1.0 ml of solution will be injected into the buccal sulcus after which 0.5ml of anesthetic solution will be injected in the inter papillary region or the palatal region depending up on the technique used. Anxiety level is assessed before the procedure by assessing, pulse rate(P.R), oxygen saturation(spO2) with the help of pulse oximeter while questionnaire will be administer through interview to assess anxiety. Immediately after the LA administration, pain will be assessed in both the techniques by Visual Analogue Scale (VAS) and WONG- BAKER PAIN SCALE(FPS). After objective and subjective evaluation, and confirming that the patient is anesthetized, extraction will be done. The pain will be evaluated in immediate post extraction time by using the VAS and FAS scale. Post extraction anxiety level of child will be assessed using, pulse rate (P.R), oxygen saturation (spO2) with the help of pulse oximeter, and questionnaire will be administered through interview. The collected data will be entered in MS excel and the statistical analysis will be done using the software, Statistical Package for the Social Sciences. One of the common reason for developing dental fear and anxiety among children is the past painful experience by the patient during dental extraction. Trans-papillary injection is one of the alternative techniques by which the patient can be administered local anesthesia comparatively in a less painful way and increase overall experience of tooth extraction and help in decreasing dental fear and anxiety which lead to more frequent dental clinic visit and in turn increase the oral health related quality of life. |