| CTRI Number |
CTRI/2026/03/107027 [Registered on: 30/03/2026] Trial Registered Prospectively |
| Last Modified On: |
27/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study comparing a Tapentadol nasal spray and Diclofenac-Paracetamol tablets for pain relief after wisdom tooth removal surgery.” |
|
Scientific Title of Study
|
Comparative Clinical Evaluation of Analgesic Efficacy of Tapentadol Intranasal Spray and Diclofenac Paracetamol Oral Tablet in Post Surgical Mandibular Third Molar Impaction. |
| 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 Shweta Gurudatta Rajput |
| Designation |
MDS 2nd Oral and Maxillofacial Surgery |
| Affiliation |
Nair Hospital Dental College |
| Address |
Dept Of Oral & Maxillofacial surgery Roomno 107, Nair Hospital Dental College,Dr.Anandrao Nair Chowk Mumbai Central, Mumbai, Maharashtra, 400008
Dept Of Oral & Maxillofacial surgery Roomno 107, Nair Hospital Dental College,Dr.Anandrao Nair Chowk Mumbai Central, Mumbai, Maharashtra, 400008
Mumbai
MAHARASHTRA
400008
India |
| Phone |
9967499150 |
| Fax |
|
| Email |
drshwetarajputomfs@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Snehal N Ingole |
| Designation |
Associate Professor,Department of Oral and Maxillofacial Surgery |
| Affiliation |
Nair Hospital Dental College |
| Address |
Dept Of Oral & Maxillofacial surgery Roomno 107, Nair Hospital Dental College,Dr.Anandrao Nair Chowk Mumbai Central, Mumbai, Maharashtra, 400008
Dept Of Oral & Maxillofacial surgery Roomno 107, Nair Hospital Dental College,Dr.Anandrao Nair Chowk Mumbai Central, Mumbai, Maharashtra, 400008
Mumbai
MAHARASHTRA
400008
India |
| Phone |
9987483998 |
| Fax |
|
| Email |
ingole.snehal@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Snehal N Ingole |
| Designation |
Associate Professor,Department of Oral and Maxillofacial Surgery |
| Affiliation |
Nair Hospital Dental College |
| Address |
Dept Of Oral & Maxillofacial surgery Roomno 107, Nair Hospital Dental College,Dr.Anandrao Nair Chowk Mumbai Central, Mumbai, Maharashtra, 400008
Dept Of Oral & Maxillofacial surgery Roomno 107, Nair Hospital Dental College,Dr.Anandrao Nair Chowk Mumbai Central, Mumbai, Maharashtra, 400008
Mumbai
MAHARASHTRA
400008
India |
| Phone |
9987483998 |
| Fax |
|
| Email |
ingole.snehal@rediffmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Shweta Gurudatta Rajput |
| Address |
Nair Hospital Dental College Dr Anandrao Nair Chowk Mumbai Central, Mumbai, Maharashtra, 400008.
|
| Type of Sponsor |
Other [Self- Financed] |
|
|
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 Shweta Gurudatta Rajput |
Nair Hospital Dental College |
Dept Of Oral & Maxillofacial surgery Roomno 107, Nair Hospital Dental College,Dr.Anandrao Nair Chowk Mumbai Central, Mumbai, Maharashtra, 400008
Mumbai
MAHARASHTRA |
9967499150
drshwetarajputomfs@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Nair Hospital Dental College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Impacted Mandibular third molar tooth. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Tablet Diclofenac 5omg + Tablet Paracetamol 325 mg |
Diclofenac & Paracetamol belongs to a class of non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs are very popular analgesics routinely prescribed, over the counter drugs which acts by inhibiting COX enzyme and thus prostaglandin synthesis. These drugs act as antipyretic, analgesic and anti-inflammatory agents. Diclofenac is a Preferential COX 2 inhibitor (inhibitory activity on COX 2 is greater than COX 1) while paracetamol has analgesic-antipyretic with poor anti- inflammatory properties.
Dose - Tab Diclofenac 50mg + Tab Paracetamol 325 mg
Frequency - 3 times a day
Route of administration - Oral
Total duration - 3days |
| Intervention |
Tapentadol Intranasal Spray |
Tapentadol is a novel, centrally acting synthetic opioid analgesic with two mechanisms of action that confers broad efficacy, as demonstrated in a variety of preclinical analgesia models. The pharmacologic activity of tapentadol is due to both mu-opioid receptor (MOR) agonism and norepinephrine reuptake inhibition.
The association of the low MOR-affinity with only a slight decrease in analgesic potency suggests that the norepinephrine reuptake inhibitory effect of tapentadol contributes to its analgesic effects. The oral bio availabilities of morphine and tapentadol in humans are approximately 34% and 32%, respectively. Tapentadol has no pharmacologically active metabolites. Furthermore, it has a low affinity for plasma proteins and is metabolized primarily by nonoxidative pathways. Therefore, the potential for drug–drug interactions appear to be low.
Dose:225mg/ml or 22.5mg/spray
Frequency: SOS basis (stat) or maximum 3 sprays per day.
Route of administration:Intranasal
Total duration: 3 days
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1)Healthy patients aged 18 to 45 years of either gender who requires surgical extraction of Impacted mandibular third molar.
2)Patient who are willing to take part in the study.
3)Patient who are free of any systemic disease.
4)Literate/mentally sound/capable of understanding the procedure & VAS to note down the scores.
|
|
| ExclusionCriteria |
| Details |
1)Patient who may be allergic or hypersensitive to local anaesthesia, study drugs, and medications such as antibiotics and anti-inflammatory treatment.
2)Patient who are in poor health conditions including Cardiac disorders, Diabetes, Hepatitis, Blood disorders, G.I Bleeding or ulcers, Chronic Kidney disorders.
3)Patient with mental illness, Pregnant women and lactating mothers.
4)Patient receiving corticosteroids treatment.
5)Patient with conditions like OSMF, Hypoplastic mandible that may lead smaller mouth opening.
6)Patient with underlying nasal pathology viz rhinitis, polyps,
and deviated nasal septum.
7)Patients with respiratory depression or conditions that compromise
respiratory function (e.g., chronic obstructive pulmonary disease, severe asthma)
8)Individuals with a history of substance abuse / addiction or Alcoholics.
9)Patients taking medications for neurological and psychiatric disorders e.g.
- Antidepressants: Monoamine Oxidase Inhibitors (MAOIs), Selective
Serotonin receptor inhibitors.
- Antipsychotics: Quetiapine, Olanzapine
- Benzodiazepines, Gabapentin, Pregabalin
- Muscle relaxants: Cyclobenzaprine, Methocarbamol
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Post-operative pain intensity measured using the Visual Analogue Scale (VAS) to compare the analgesic efficacy of Tapentadol intranasal spray and Diclofenac-Paracetamol oral tablet |
Comparison of post-operative pain intensity between Tapentadol intranasal spray and Diclofenac-Paracetamol oral tablet using the Visual Analogue Scale (VAS) at 1, 2, 4, 6, 12, and 24 hours after mandibular third molar dis-impaction surgery. |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the effects of Tapentadol Intranasal spray & Diclofenac Paracetamol Oral tablet in managing swelling following mandibular third molar surgery. |
Swelling is measured for both the groups pre-operative, Day1, Day 3 & Day 7 |
| To compare the effects of Tapentadol Intranasal spray & Diclofenac Paracetamol Oral tablet in managing oral opening (trismus) following mandibular third molar surgery. |
Oral opening (trismus) is measured in both the groups pre operative, Day 1, Day 3 & Day 7. |
|
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Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
15/04/2026 |
| 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="1"
Months="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Clinical Study Report
Response (Others) - pre operative and post operative pictures
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) -
- For how long will this data be available start date provided 10-12-2027 and end date provided 10-12-2050?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
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Brief Summary
|
KEY ARTICLES : Md. Khizar Hussain Mazhari, Jagadish Chandra and Joyce P. 2023. DOI:10.9734/JPRI/2023/v35i87340 conducted a study to evaluate the efficacy of post extraction pain control between Tapentadol nasal spray and oral administration of Diclofenac tablet with bilateral surgical extraction of mandibular 3rd molar. They observed that Tapentadol Intranasal spray has a great efficacy in post extraction pain control as compared with Diclofenac Tablet (50mg).
2) Swarbhanu Porel et al, in 2023. e-ISSN: 0975-5160, p-ISSN: 2820-2651 published a research article on The Effectiveness of Tapentadol in Perioperative Analgesia: A Prospective Comparative Study of Nasal spray and Oral Preparations. Elective laparoscopic cholecystectomies under general anesthesia were carried out in 60 Adults of either sex. They were divided into 2 groups, Each group of 30 individuals. One group received Intranasal Tapentadol, (Group N–Nasal Tapentadol) and the other group received Oral Tapentadol (Group T -Oral Tapentadol) They concluded that nasal Tapentadol had better analgesic efficacy and hemodynamic stability as compared to oral formulations.
3)Dr. Sumitoj Singh et al.,2023. ISSN:0975-3583,0976-2833 conducted a study to compare the efficacy of Tapentadol Nasal Spray and Intramuscular injection Diclofenac sodium as an analgesic for post-operative pain management in patients undergoing various elective and emergency surgeries. They concluded, that mean pain score was less in the Tapentadol nasal spray group as compared to the intramuscular Diclofenac sodium group at all intervals by VAS. (p<0.05).
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