| CTRI Number |
CTRI/2025/02/080399 [Registered on: 12/02/2025] Trial Registered Prospectively |
| Last Modified On: |
08/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing Hyaluronidase and Dexamethasone Injections for reducing Pain, Swelling and inability to open mouth after Wisdom Tooth Surgery. |
|
Scientific Title of Study
|
Evaluation of Hyaluronidase Vs Dexamethasone Submucosal Injections in Reducing Post Operative Sequalae after Disimpaction of Bilateral Impacted Mandibular Third Molar - A Split Mouth Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Edara Samuel |
| Designation |
Post Graduate |
| Affiliation |
Dr.Ntr university of health sciences |
| Address |
Department of oral and maxillofaciaL surgery. Room no: 3 .Sibar institute of dental sciences
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
9704365500 |
| Fax |
|
| Email |
samuel.edara@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr P Srinivas Chakravarthi |
| Designation |
Professor |
| Affiliation |
Dr.Ntr university of health sciences |
| Address |
Department of oral and maxillofaciaL surgery. Room no: 3 .Sibar institute of dental sciences
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
9392103703 |
| Fax |
|
| Email |
pscomf@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Edara Samuel |
| Designation |
Post Graduate |
| Affiliation |
Dr.Ntr university of health sciences |
| Address |
Department of oral and maxillofaciaL surgery. Room no: 3 .Sibar institute of dental sciences
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
9704365500 |
| Fax |
|
| Email |
samuel.edara@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sibar Institute of dental sciences, Takellepadu, Guntur, Andhra Pradesh 522509 India |
|
|
Primary Sponsor
|
| Name |
Edara samuel |
| Address |
Department of oral and maxillofacial surgery ,Room no :3 Sibar institute of dental sciences ,Takellapadu,Guntur, Andhra Pradesh 522509 |
| Type of Sponsor |
Other [] |
|
|
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 Edara samuel |
Sibar institute of dental sciences |
Department of oral and maxillofaciaL surgery. Room no: 3.
Guntur
ANDHRA PRADESH |
9704365500
samuel.edara@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee Sibar institute of dental sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K011||Impacted teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Dexamethasone |
1ml , one time, Parenteral route-submucosal injection for one minute slowly. |
| Intervention |
Hyaluronidase |
1500 International Units 1ml , one time, Parenteral route-submucosal injection for one minute slowly. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
44.00 Year(s) |
| Gender |
Both |
| Details |
Age group 18-40 years
Healthy and Non-Diabetic patients.
Patients falling under physical status classification (American society of Anesthesiologists) ASA 1 and ASA 2
individuals
Compliance with the study following voluntary participation.
Patients with similar class of Bilateral Impacted Mandibular molar teeth (mesioangular, class-1,position A or B)
|
|
| ExclusionCriteria |
| Details |
History of adverse effects to any drugs to be administered during the study period.
Pregnant or lactating woman.
Long-term use of drugs that affect systemic inflammatory response.
Patients who are not willing to be involved in the study.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Post operative pain, mouth opening and swelling |
Pre operative day 1, post operative days 3rd, 7th ,14th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| No Secondary outcome measured .Any adverse events will be noted |
Pre operative day 1, post operative days 3rd, 7th ,14th day |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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 1 |
|
Date of First Enrollment (India)
|
01/04/2025 |
| 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 Applicable |
| 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
|
Aim of the proposal: To evaluate the
efficacy of submucosal Hyaluronidase vs Dexamethasone injections in reducing
postoperative sequalae like Pain, Mouth opening and Swelling after disimpaction
of bilateral mandibular third molar.
Specific Objectives:
To assess and compare the
effectiveness of Hyaluronidase and Dexamethasone in post- operative pain control.
2) To assess and compare the
effectiveness of Hyaluronidase and Dexamethasone in Mouth opening.
3) To assess and compare the
effectiveness of Hyaluronidase and Dexamethasone in reducing facial swelling.
Materials &Methods: Source & Selection of Samples:
The present study will be conducted in the
department of oral and maxillofacial surgery. 44 patients who met with
inclusion criteria will be selected from out-patient department of oral and
maxillofacial surgery. Summary : Patients reporting to the department of oral and
maxillo-Facial Surgery during the study period (Duration-18
months) for bilateral mandibular third molar surgery are included based on inclusion criteria,.Study will be explained & written informed consent
will be taken, Randomization is done alternatively into two groups, Group-1 Administration of
submucosal Hyaluronidase inj(1500
IU) at surgical site(mesial,distal and buccal) 1ml after Surgical procedure is
done under local Anaesthesia and flap closure with silk sutures. Group-2 Administration of
submucosal Dexamethasone inj
(4mg) at surgical site site(mesial,distal and buccal) 1ml after Surgical
procedure is done under local Anaesthesia and flap closure with silk sutures. Pain, Mouth opening and Facial swelling will be
measured Pre-operative and compared with post-operative day 3 & day 7 & day 14. 1) The Pain score will be assessed using Visual Analog
scale 2) Mouth opening
measured with Digital Vernier calipers. 3) Facial swelling measured with measuring thread as
three linear measurements.a) Tragus – Oral commissure b) Tragus – Pogonion c) Lateral Canthus - Gonion. All the 3 linear measurements are summed up and
calculated. Statistical
test: 1) Repeated measures of ANOVA at different
time intervals : To
calculate the outcome variables in the
two groups and comparison between the groups. 2) Mann Whitney test for measuring Pain with
Visual Analog scale.3) Independent sample T test for comparing differences between Pre-operative,
Post-operative day-3 ,day-7 and day-14. Results and interpretation of data is done. OUTCOME: post-operative complications
like pain, mouth opening and swelling will be assessed.
|