| CTRI Number |
CTRI/2025/12/099719 [Registered on: 23/12/2025] Trial Registered Prospectively |
| Last Modified On: |
23/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effects of Hyaluronidase and Dexamethasone on Recovery After Wisdom Tooth Removal |
|
Scientific Title of Study
|
COMPARISON OF THE EFFECTS OF SUBMUCOSAL
INFILTRATION OF HYALURONIDASE AND
DEXAMETHASONE ON POSTOPERATIVE
COMPLICATIONS FOLLOWING IMPACTED THIRD
MOLAR SURGERY a Randomised Control Trial |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ilakkiya |
| Designation |
Student |
| Affiliation |
Tagore Dental College and Hospital |
| Address |
Tagore Dental College and Hospital Rathinamangalam Melakottaiyur Post 600127
Kancheepuram
TAMIL NADU
600127
India |
| Phone |
7904511032 |
| Fax |
|
| Email |
ilakkiya24selvam@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jones Jayabalan |
| Designation |
Associate Professor |
| Affiliation |
Tagore Dental College and Hospital |
| Address |
Tagore Dental College and Hospital Rathinamnagalam Melakottaiyur post 600127
Kancheepuram
TAMIL NADU
600127
India |
| Phone |
7845619673 |
| Fax |
|
| Email |
jonesjayabalan27@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jones Jayabalan |
| Designation |
Associate Professor |
| Affiliation |
Tagore Dental College and Hospital |
| Address |
Tagore Dental College and Hospital Rathinamangalam Melakottaiyur post 600127
Kancheepuram
TAMIL NADU
600127
India |
| Phone |
7845619673 |
| Fax |
|
| Email |
jonesjayabalan27@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Ilakkiya |
| Address |
Tagore Dental College and Hospital Rathinamnaglam Melakottaiyur post 600127 |
| Type of Sponsor |
Other [myself] |
|
|
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 jones jayabalan |
Tagore dental college and hospital |
Department of oral and maxillofacial surgery room no 3
Kancheepuram
TAMIL NADU |
7845619673
jonesjayabalan27@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Tagore Dental College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
persons with mesioangular or vertically impacted third molars |
| Patients |
(1) ICD-10 Condition: K011||Impacted teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
dexamethasone |
dexamethasone is given to patients following third molar surgery for 1 year |
| Comparator Agent |
hyaluronidase |
hyaluronidase is given to patients following third molar surgery |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1.Impacted mandibular third molar with class I, II; level A or B;
2.mesioangular vertical position characteristics according to the Pell–Gregory and Winter classifications |
|
| ExclusionCriteria |
| Details |
1.Patients who fall under ASA III and above
2.Pregnant patients and Lactating mothers
3.Patients with history of any drug allergy
4.Patients with Pericoronal abscess, Cyst or Tumours associated with the Impacted tooth
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in swelling pain and improvement in mouth opening after surgical removal of impacted mandibular third molar |
1st day 3rd day 7th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
03/01/2026 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 - NO
|
|
Brief Summary
|
This randomized controlled trial aims to compare the effectiveness of submucosal hyaluronidase and submucosal dexamethasone in reducing postoperative complications after the surgical removal of impacted third molars (wisdom teeth). Patients undergoing third molar surgery will be randomly assigned to receive either hyaluronidase or dexamethasone before the procedure. The study will evaluate key postoperative outcomes such as pain, swelling, trismus (restricted mouth opening), and overall healing at various time intervals after surgery. By assessing and comparing these two commonly used agents, the study intends to determine which medication provides better postoperative comfort and faster recovery for patients.
|