| CTRI Number |
CTRI/2025/12/099293 [Registered on: 17/12/2025] Trial Registered Prospectively |
| Last Modified On: |
16/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing the efficacy of oral v/s intra nasal Tapentadol in the pain management after third molar extraction A randomized control trial |
|
Scientific Title of Study
|
Comparing the efficacy of oral v/s intra nasal Tapentadol in the pain management after third molar extraction A randomized control 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 Poorva Kulkarni |
| Designation |
Post graduate student |
| Affiliation |
Meenakshi Academy of Higher education |
| Address |
Room no. 5 Department of Oral and Maxillofacial Surgery
Meenakshi Ammal Dental college and hospital Alapakkam main road, Maduravoyal Channai
Chennai
TAMIL NADU
600095
India |
| Phone |
9987429788 |
| Fax |
|
| Email |
drpoorvackulkarni@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prabhu Shankar |
| Designation |
Professor Department of Oral and Maxillofacial Surgery |
| Affiliation |
Meenakshi Academy of Higher education |
| Address |
Room no. 5 Meenakshi Ammal Dental college and hospital Alapakkam main road, Maduravoyal Chennai
Chennai
TAMIL NADU
600095
India |
| Phone |
9500463693 |
| Fax |
|
| Email |
drpoorvackulkarni@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Poorva Kulkarni |
| Designation |
Post graduate student |
| Affiliation |
Meenakshi Academy of Higher education |
| Address |
Room no. 5 Department of Oral and Maxillofacial Surgery
Meenakshi Ammal Dental college and hospital Alapakkam main road, Maduravoyal Chennai
Chennai
TAMIL NADU
600095
India |
| Phone |
9987429788 |
| Fax |
|
| Email |
drpoorvackulkarni@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [] |
|
|
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 Poorva Kulkarni |
Meenakshi Ammal Dental College |
Room no. 5 Department of ORal and Maxillofacial Surgery Meeanakshi Ammal Dental College and Hospital 3538 6RF, Alapakkam Main Rd, Janaki Nagar, Maduravoyal, Chennai, Tamil Nadu 600095
Thiruvallur
TAMIL NADU |
9987429788
drpoorvackulkarni@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee Meenakshi Ammal Dental College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
impacted mandibular third molars |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Tapentadol Hydrochloride oral tablet |
one tablet per dose 50mg per tablet 3 times a day for three days |
| Intervention |
Tapentadol Nasal Spray |
Two sprays per dose 22.5mg of drug dispensed per spray so total 45mg of drug per dose three times a day for three days |
| Comparator Agent |
zerodol p. tablet |
Combination drug one tablet per dose three times a day for three days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients who consent to be part of the study.
2.Patients ranging from the age of 18-35 years.
3.Patients in ASA 1 category
4.Patients with mesioangular Impacted 3rd molars with class 2 position B (Pell and Gregory classification) indicated for trans-alveolar extraction under local anesthesia. |
|
| ExclusionCriteria |
| Details |
1.Patients who do not consent to be part of the study
2.Patients with significant medical comorbidities eg. Diabetes, Hypertension, thyroid discrepancies, bronchial asthma, and other medical concerns
3.Patient allergic to active drug prescribed - Tapendtadol
4.Patients with underlying nasal pathologies like allergic rhinitis, nasal polyps, and deviated septum.
5.Pregnant women or lactating mothers
6.Patients taking selective serotonin reuptake inhibitors (SSRIs)
7.Patients taking “opioid like medications” eg. Pentazocine, nalbuphimine
8.Acute alcoholism |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Tapentadol nasal spray is a superior analgesic than oral tapetatadol of zerodol p |
Visual Analog Pain Scale to be checked at 6hr post operatively 1st day post operatively and 3rd day post opeartively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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
|
N/A |
|
Date of First Enrollment (India)
|
15/01/2026 |
| 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="6"
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
|
This randomized control trial aims to compare the efficacy of oral and intranasal Tapentadol Hydrochloride for managing postoperative pain following third molar extractions. The study is being conducted in the Department of Oral and Maxillofacial Surgery at Meenakshi Ammal Dental College and Hospital, Chennai from 2023 to 2026 A total of 75 patients aged 18 to 35 years will be included divided equally into three groups of 25 participants each All patients will undergo transalveolar extraction of mesioangular impacted mandibular third molars of Class 2 Position B type under local anesthesia
Group A will receive the control medication consisting of Aceclofenac and Paracetamol twice daily for three days. Group B will receive Tapentadol Hydrochloride as an intranasal spray 45 mg every six hours for three days while Group C will receive oral Tapentadol Hydrochloride tablets 100 mg every six hours for three days All groups will be prescribed standard postoperative medications, including antibiotics and enzymes If adequate pain relief is not achieved Ketorolac will be provided as rescue analgesia
Pain will be assessed using a Visual Analogue Scale at intervals of 6 hours on postoperative day 0 day 1 and day 3 The scale categorizes pain from 0 indicating no pain to 10 indicating unbearable pain grouped into six levels of intensity Statistical analysis will be performed using SPSS software version 27 Descriptive data will be presented as mean and standard deviation while normality will be tested with the Shapiro Wilk test One way ANOVA with post hoc Tukey HSD test or Kruskal Wallis test with Dunn’s post hoc analysis will be applied as appropriate Chi square tests will be used for categorical data
The studys objective is to determine whether intranasal Tapentadol provides superior or comparable pain control to the oral formulation thereby offering a faster noninvasive and patient compliant alternative for postoperative pain management following third molar surgery |