| CTRI Number |
CTRI/2023/05/052286 [Registered on: 03/05/2023] Trial Registered Prospectively |
| Last Modified On: |
03/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
A comparative study to evaluate the anti-inflammatory and analgesic activity of flavonoids and serratiopeptidase in patients undergoing mandibular third molar surgery–A Randomized Controlled Trial |
|
Scientific Title of Study
|
A comparative study to evaluate the anti-inflammatory and analgesic activity of flavonoids versus serratiopeptidase in combination with diclofenac in patients undergoing mandibular third molar surgery–A Randomized Controlled Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nitin B |
| Designation |
Post Graduate |
| Affiliation |
Sri Venkateshwaraa Dental College Pondicherry |
| Address |
No.420 4th Floor Department of Oral and Maxillofacial Surgery 13 A Sri Venkateshwaraa Dental College Pondicherry Villupuram Main Road Ariyur
Pondicherry
PONDICHERRY
605102
India |
| Phone |
8903387423 |
| Fax |
|
| Email |
writetonitinbabu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yuvaraj V |
| Designation |
Professor and Head |
| Affiliation |
Sri Venkateshwaraa Dental College |
| Address |
No 420 4th Floor Department of Oral and Maxillofacial Surgery Sri Venkateshwaraa Dental College Pondicherry Villupuram Main Road Ariyur
Pondicherry
PONDICHERRY
605102
India |
| Phone |
9344235655 |
| Fax |
|
| Email |
omfssvdc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nitin B |
| Designation |
Post Graduate |
| Affiliation |
Sri Venkateshwaraa Dental College |
| Address |
No 420 Fourth Floor Department of Oral and Maxillofacial Surgery 13 A Sri Venkateshwaraa Dental College Pondicherry Villupuram Main Road Ariyur
Pondicherry
PONDICHERRY
605102
India |
| Phone |
8903387423 |
| Fax |
|
| Email |
writetonitinbabu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Venkateshwaraa Dental College |
|
|
Primary Sponsor
|
| Name |
Dr Nitin B |
| Address |
No 13 A Sri Venkateshwaraa Dental College Pondy VIllupuram Main Road Ariyur Puducherry |
| 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 Nitin B |
Sri Venkateshwaraa Dental College |
No 420 Fourth Floor Department of Oral and Maxillofacial Surgery 13A Sri Venkateshwaraa Dental College Pondy Villupuram Main Road Ariyur
Pondicherry
PONDICHERRY |
8903387423
writetonitinbabu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institution Ethical Committee (Human Studies) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K006||Disturbances in tooth eruption, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Drug |
Drug - Serratiopeptidase in combination with Diclofenac and Flavonoids in combination with Diclofenac
Route : Oral
Duration : 3 Days
Dosage for Serratiopeptidase in combination with Diclofenac
Serratiopeptidase :10 mg
Diclofenac Sodium :50 mg
Dosage for Flavonoids in combination with Diclofenac
Trypsin : 48 mg
Bromelain : 90 mg
Rutoside Trihydrate : 100 mg
Diclofenac Sodium :50 mg
|
| Comparator Agent |
Drug |
Serratiopeptidase in combination with Diclofenac Vs Flavonoids in combination with Diclofenac |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA I patients in the age group of 18- 40 years with either gender
2. All impacted mandibular third molars requiring surgical extraction
3. CLASS I, CLASS II, POSITION-A and POSITION-B Impacted third molar According to Pell and Gregory classification
4.Patient willing to participate in the study |
|
| ExclusionCriteria |
| Details |
1.Acute infection
2.Patient allergic to administrated drugs
3.Patients with Gastric Ulcers
4.Patient with bleeding disorders
5.Pregnancy and Lactating women
6.Immunocompromised patient
Mentally challenged patient
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary Outcome: Pain
Secondary Outcome: Swelling and Trismus |
Both Primary and Secondary outcomes are measured on the pre operative day (Day 0) and post operative days (Day 1and Day 3) that is during the course of the intervention administered and post operative days (Day 7 and Day 12) for follow up
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Swelling
Trismus |
1ST POST-OP DAY
3RD POST OP DAY
7TH POST OP DAY
12TH POST OP DAY
|
|
|
Target Sample Size
|
Total Sample Size="92"
Sample Size from India="92"
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)
|
10/05/2023 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Surgical removal of mandibular third molar is usually associated with postsurgical sequalae that may have both biological and social impact. Patients report common post-operative complications such as pain, swelling and trismus which affects the quality of life. Diclofenac is a proven, commonly prescribed nonsteroidal anti-inflammatory drug (NSAID) that has analgesic, anti-inflammatory, and antipyretic properties, and has been shown to be effective in treating a variety of acute and chronic pain and inflammatory conditions Serratiopeptidase is a widely used proteolytic enzyme in therapeutic applications. It has shown significant anti-inflammatory, anti-edemic, and analgesic effects in various areas including surgery, orthopaedics, otorhinolaryngology, gynaecology, and dentistry. It is well known amongst researchers for its caseinolytic (proteolytic) and fibrinolytic properties. Combination of Proteolytic enzyme with Flavonoids that includes trypsin, bromelain and rutoside showed increased significance in reduction of pain and inflammation. Studies have shown that using a proteolytic enzyme aids a better and fast healing when compared to usual anti-inflammatory drugs hence this study is done to find the anti-inflammatory and analgesic activity in combination of Enzyme and NSAIDs |