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CTRI Number  CTRI/2024/08/073116 [Registered on: 29/08/2024] Trial Registered Prospectively
Last Modified On: 11/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To study the effect of hyaluronic acid on pain swelling and trismus after removal of third molar  
Scientific Title of Study   Effect of intrasocket application of hyaluronic acid on pain, swelling and trismus after surgical extraction of impacted mandibular third molar  
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 Deepshikha Bhave 
Designation  PG student 
Affiliation  Krishna Vishwa Vidyapeeth 
Address  Department of OMFS, School of dental sciences,Karad

Satara
MAHARASHTRA
415539
India 
Phone  09673783487  
Fax    
Email  deepshikhabhave@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Mouneshkumar CD 
Designation  Professor 
Affiliation  Krishna Vishwa Vidyapeeth 
Address  Department of OMFS, School of dental sciences,Karad

Satara
MAHARASHTRA
415539
India 
Phone  7709307635  
Fax    
Email  drmouneshkumarchapi07@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Deepshikha Bhave 
Designation  PG student 
Affiliation  Krishna Vishwa Vidyapeeth 
Address  Department of OMFS, School of dental sciences,Karad

Satara
MAHARASHTRA
415539
India 
Phone  09673783487  
Fax    
Email  deepshikhabhave@gmail.com  
 
Source of Monetary or Material Support  
Krishna Vishwa Vidyapeeth Malkapur Karad Maharashtra India 415539 
 
Primary Sponsor  
Name  Krishna Vishwa Vidyapeeth 
Address  Krishna Vishwa Vidyapeeth Malkapur Karad Maharashtra India 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Deepshikha Bhave  Krishna Vishwa Vidyapeeth  OMFS opd no 24, School of Dental Sciences Krishna Vishwa Vidyapeeth Malkapur Karad 415539
Satara
MAHARASHTRA 
9673783487

deepshikhabhave@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Patients with mesioangular impacted mandibular third molar 
Patients  (1) ICD-10 Condition: K011||Impacted teeth,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Gelfoam  Abgel  
Intervention  Hyaluronic acid  Hyalgun 20mg/2ml will be injected in the abgel which is placed in the socket after surgical extraction of mesioangular impacted third molar 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  Patients with mesioangular impacted mandibular third molar with moderate difficulty index according to Pederson difficulty index.
Patient willing for participation in study.
 
 
ExclusionCriteria 
Details  Patients outside the 18 – 45 years age group.
Those with signs of peri-coronitis and/or pain before surgery.
Those with allergy to Hyaluronic acid.
Medically compromised patients
Patients having osteopetrosis, osteoporosis, osteoradionecrosis or any bone pathology.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Swelling
Pain
Trismus  
baseline
1st post op day
3rd post op day
7th post op day 
 
Secondary Outcome  
Outcome  TimePoints 
Number of analgesic consumed by patient  1,3,7 day 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   10/09/2024 
Date of Study Completion (India) 20/09/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="1"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
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
Brief Summary  

Mandibular third molar removal is one of the most widely done treatments in the oral cavity. Nevertheless, surgeons often encounter undesirable post-operative sequalae. These inflammatory responses after wisdom teeth surgery may badly affect a patients’ quality of life.

Post-operative complications like dry socket, nerve damage, bone fracture, delayed healing and damage of the second molar can also happen quite frequently following the surgical removal of mandibular third molars .Though traditional measures such as non steroidal anti-inflammatory drugs and corticosteroids proposed for control of postoperative complications work well ,their potential side effects have led to search for  an easy applicable way  to reduce post-operative pain and swelling.

Hyaluron or hyaluronic acid is a biomaterial that has been introduced as an alternative approach to enhance wound healing. Hyaluronic acid is a major carbohydrate having multifaceted roles. It plays a critical role in wound healing by inducing early granulation tissue formation, inhibiting destructive inflammation and promoting angiogenesis. Owing to its non-immunogenic and non-toxic properties, it has been used in ophthalmology, dermatology, and rheumatology and now has been introduced for intraoral use. It is available in gel or  liquid form to be applied topically in oral cavity.The study aims  to determine the effect of intra socket hyaluronic acid application  on post extraction pain, swelling and trismus after surgical removal of 3rd molar .

 
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