| CTRI Number |
CTRI/2025/08/092346 [Registered on: 04/08/2025] Trial Registered Prospectively |
| Last Modified On: |
03/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparing how well three different treatments work in reducing pain, swelling, and discomfort after wisdom tooth removal: cold saline rinses, regular saline rinses combined with oral enzyme tablets, and regular saline rinses combined with an anti-inflammatory injection under the gum. |
|
Scientific Title of Study
|
COMPARISON OF EFFICACY OF COLD SALINE IRRIGATION, NORMAL SALINE IRRIGATION WITH ORAL ENZYME PREPARATION AND NORMAL SALINE IRRIGATION WITH SUBMUCOSAL DEXAMETHASONE INFILTRATION ON POST OPERATIVE SYMPTOMS AFTER SURGICAL REMOVAL OF IMPACTED MANDIBULAR THIRD MOLAR - A RANDOMIZED CONTROLLED TRIAL |
| Trial Acronym |
NIL |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rishabh Yadav |
| Designation |
Post graduate student |
| Affiliation |
DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY KLE VK INSTITUTE OF DENTAL SCIENCES, BELAGAVI |
| Address |
Room Number 5 Department of Oral and Maxillofacial Surgery KLE VK Institute of Dental Sciences JNMC campus Nehru Nagar Belagavi JNMC CAMPUS , NEHRU NAGAR BELAGAVI . Belgaum KARNATAKA 590010 India |
| Phone |
9967970913 |
| Fax |
|
| Email |
rishaby14@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Rishabh Yadav |
| Designation |
Post graduate student |
| Affiliation |
DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY KLE VK INSTITUTE OF DENTAL SCIENCES, BELAGAVI |
| Address |
Room Number 5 Department of Oral and Maxillofacial Surgery KLE VK Institute of Dental Sciences JNMC Campus Nehru Nagar Belagavi JNMC CAMPUS , NEHRU NAGAR , BELAGAVI. Belgaum KARNATAKA 590010 India |
| Phone |
9967970913 |
| Fax |
|
| Email |
rishaby14@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
DR SD Baliga |
| Designation |
Professor |
| Affiliation |
KLE VK Institute of Dental Sciences |
| Address |
Room Number 5 Department of oral and maxillofacial Surgery KAHERS KLE VK Institute of Dental Sciences Belagavi
Belgaum KARNATAKA 590010 India |
| Phone |
9341102665 |
| Fax |
|
| Email |
baliga1974@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLE VK Institute of Dental Sciences , BELAGAVI 590010 , KARNATAKA , INDIA. |
|
|
Primary Sponsor
|
| Name |
Rishabh Yadav |
| Address |
Room Number 5 Department of Oral and Maxillofacial Surgery KLE VK Institute of Dental Sciences JNMC Campus Nehru Nagar Belagavi |
| Type of Sponsor |
Other [self funding] |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rishabh Yadav |
KAHERS KLE VK Institute of Dental Sciences |
Room Number 5 Department of oral and maxillofacial surgery KLE VK Institute of Dental Sciences JNMC Campus Nehru Nagar Belagavi Belgaum KARNATAKA |
9967970913
rishaby14@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Research and Ethics Committee KLE VKIDS |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Impacted tooth cases |
| Patients |
(1) ICD-10 Condition: K011||Impacted teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Normal Saline Irrigation With Oral Enzyme Preparation |
Irrigation of Extraction Socket with Normal Saline Followed by Prescribing Oral Enzyme Preparation After Closure of Extraction Socket. |
| Comparator Agent |
Normal Saline Irrigation with Submucosal Dexamethasone Infiltration |
Extraction Socket will be Irrigated with Normal Saline followed by Infiltration with Dexamethasone Submucosally. |
| Intervention |
Cold Saline |
Extraction Socket will be Irrigated with Cold Saline having a Temperature of 2-8 Degrees Centigrade. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1) pt belonging to the age group of 18-40 years .
2) pt who have not used any antibiotic, anti-inflammatory 1 week before the surgery
3)pt with mild to moderate surgical difficulty on evaluation according to Pederson difficulty index score 3-4 and 5-7
4) pt with normal bleeding and clotting time
5) pt who are non smokers
6)pt with ASA 1 category
7) pt having indication for extraction of impacted mandibular third molar |
|
| ExclusionCriteria |
| Details |
1) pt who are not willing to participate or take part in the study.
2) pt with previous allergies to anaesthetic agents used.
3) pregnant or lactating female patients.
4) pt who are immunocompromised or suffering from any systemic conditions.
5)pt having bacterial and fungal infection
6) pt allergic to corticosteroids.
7) pt on anticoagulant drugs
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
|
Outcome Assessor Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| Post operative swelling |
3rd and 7th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Post operative pain |
3rd & 7th day |
| Post operative trismus |
3rd & 7th day |
|
|
Target Sample Size
|
Total Sample Size="75" Sample Size from India="75"
Final Enrollment numbers achieved (Total)= "75"
Final Enrollment numbers achieved (India)="75" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
15/08/2025 |
| Date of Study Completion (India) |
05/11/2025 |
| Date of First Enrollment (Global) |
15/08/2025 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
Third molar surgical removal is one of the most common procedures performed by Oral & Maxillofacial surgeons, it is often associated with post operative swelling, pain and trismus which are inflammatory signs and symptoms that cause discomfort and also can have an impact on quality of life
To reduce post operative discomfort, different pharmacological managements have been proposed by various authors;
Normal saline is commonly used as a irrigating solution in third molar surgeries as it decreases the heat generated by surgical drill while contacting bone thus reducing the chance of inflammation and tissue damage In some studies, surgeons prefer cold saline irrigation (2-8 degree celsius) and they believe that it is more effective than normal saline irrigation.
Corticosteroids have been used most frequently for post operative management after 3rd molar surgeries, dexamethasone is most commonly used for post operative swelling , pain and trismus the conventional route for dexamethasone drug delivery is through intramuscular and intravenous route ,however these techniques require additional clinical skills and may not be as pleasant to the conscious patient as well.
As an alternative submucosal injection (SM) has been reported to be an effective , convenient and straightforward way of administering dexamethasone Nonsteroidal Anti-inflammatory drugs have often been prescribed to reduce post operative inflammatory complications caused by third molar surgery, however the side effects associated are numerous primarily gastro intestinal, renal disorders , propensity to cause skin and mucosal reactions.
Hence a natural, effective, and safe remedy that lacks undesirable side effects would offer a better alternative treatment
Bromelain is a proteolytic enzyme derived from stem of pineapple plant( Ananas Comosus) and presents anti-inflammatory anti edemic and anti fibrinolytic properties , which can be beneficial in post operative management after 3rd molar surgery.
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