| 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
|
|
|
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
|
|
|
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 . |