| CTRI Number |
CTRI/2024/01/061963 [Registered on: 29/01/2024] Trial Registered Prospectively |
| Last Modified On: |
14/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
To compare the effectiveness of cold saline wash VS steroid injection in reducing discomfort after wisdom tooth removal. |
|
Scientific Title of Study
|
Efficacy of cooled saline irrigation vs. pre-operative intravenous Dexamethasone in reducing post-operative swelling, pain and trismus after surgical removal of lower impacted third molar: A single center split mouth prospective clinical 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 |
Dr Srikanth G |
| Designation |
Professor |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Oral & Maxillofacial Surgery, Manipal College of Dental Sciences, Manipal
Udupi KARNATAKA 576104 India |
| Phone |
9986455201 |
| Fax |
|
| Email |
srikanth.mds@manipal.edu |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Srikanth G |
| Designation |
Professor |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Oral & Maxillofacial Surgery, Manipal College of Dental Sciences, Manipal
Udupi KARNATAKA 576104 India |
| Phone |
9986455201 |
| Fax |
|
| Email |
srikanth.mds@manipal.edu |
|
Details of Contact Person Public Query
|
| Name |
Dr Srikanth G |
| Designation |
Professor |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Oral & Maxillofacial Surgery, Manipal College of Dental Sciences, Manipal
Udupi KARNATAKA 576104 India |
| Phone |
9986455201 |
| Fax |
|
| Email |
srikanth.mds@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Dept. of Oral & Maxillofacial Surgery, Manipal College of Dental Sciences, Manipal, Karnataka 576104 |
|
|
Primary Sponsor
|
| Name |
Dr Srikanth G |
| Address |
Department of Oral & Maxillofacial Surgery, Manipal College of Dental Sciences, Manipal |
| 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 Srikanth G |
Kasturba Medical College & Hospital |
Room 4, Dept. of Oral & Maxillofacial Surgery, Manipal College of Dental Sciences, Manipal 576104 Udupi KARNATAKA |
9986455201
srikanth.mds@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
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 |
| Intervention |
Cooled saline irrigation |
Cooled saline (4 degree C) will be used while bone drilling during wisdom tooth removal. No steroid injection will be administered to patients. Swelling, pain and difficulty in mouth opening will be evaluated post-operatively on day 0, day 3 and day 7 |
| Comparator Agent |
IV Dexamethasone 8mg |
IV Dexamethasone 8mg is administered to the patient 30 mins before undergoing wisdom tooth removal. Room temperature saline will be used during bone drilling. Swelling, pain and difficulty in mouth opening will be evaluated post-operatively on day 0, day 3 and day 7 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) 18 years or older healthy patients.
2) Bilateral impacted lower third molar needing extraction with the necessity of bone removal based on panoramic radiography.
3) Patients who live within 10km radius of the hospital.
4) Patients who give written consent. |
|
| ExclusionCriteria |
| Details |
1) Less than 18 years with comorbidities.
2) Second molars with severe periodontal defect or deep periodontal pocket.
3) Cysts or tumors around the impacted third molar.
4) History of bleeding disorders, smoking, alcoholism and pregnant patients.
5) Patients who live beyond 10 km radius of the hospital.
6) Patients who do not give written consent to participate in the study and follow up. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the intensity of post-operative morbidity (pain, facial swelling, and trismus) following surgical removal of lower impacted third molar performed using cooled saline vs. single dose intravenous (IV) Dexamathasone administered pre-operatively. |
1. Pre-operative (day 0)
2. Post-operative day 1
3. Post-operative day 3
4. Post-operative day 7 |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="32" Sample Size from India="32"
Final Enrollment numbers achieved (Total)= "26"
Final Enrollment numbers achieved (India)="26" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
01/02/2024 |
| Date of Study Completion (India) |
01/02/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This is a single-center
split-mouth clinical trial. Patients reporting to Department of Oral and
Maxillofacial Surgery, MCODS, Manipal with bilateral mandibular mesioangular or
horizontal third molar teeth and satisfying all other inclusion criteria will
be included in the study. Radiographic evaluation (orthopantomogram) will be
done to classify the impaction and those with Class I or II, level A or B impaction
will be considered. For the control group (n=32),
IV Dexamethasone will be administered 1 hour before the procedure in the
cubital fossa. For the test group (n=32), saline bottles will be refrigerated
in the department to attain a temperature of 4°C (to be confirmed with non-contact thermometer). A
gap of 21 days will be ensured between procedures on either side. The operator
and patient will not be blinded. However, the outcome assessor, who will be
another surgeon in the department, will be blinded to the procedure. Blinding will
be achieved by ensuring that the surgeon is not present in the operatory during
the procedure. All procedures will be
carried out by the same maxillofacial surgeon in the department. The routine
steps for lower third molar removal will be followed:
- Local anaesthesia with inferior alveolar,
lingual and long buccal nerve blocks (lignocaine with adrenaline
1:2,00,000).
- Modified Ward’s incision and raising a full
thickness mucoperiosteal flap.
- Osteotomy or drilling of bone around the tooth
and sectioning of tooth (702 straight carbide bur attached to a micromotor
handpiece will be used). For the test side, irrigation will be carried out
with cold saline at 4°C.
For the control side, irrigation will be carried out with saline at room
temperature.
- After tooth removal, irrigation and curettage
of the socket, Gelfoam placement and closure with simple interrupted 3-0
silk sutures will be done.
- Placement of gauze pack at the local site for 1
hour will be advised to all patients.
- All post-extraction instructions will be given
to the patient in written format.
- Suture removal to be done on 7th
post-operative day.
Medications prescribed to
both groups will be the same: Antibiotic (Amoxicillin 500mg + Clavulanic acid 125mg
2 times/day for 5 days), analgesic (Paracetamol 650mg 3 times/day for the first
3 days, and then SOS), and chlorhexidine mouthwash (3 times/day) after the
first 24 hours. The parameters that will
be measured are:
- Facial measurement: This parameter will help us
determine facial swelling. It will be measured with the help of 4
reference points on the face and a flexible scale (cm):
- Lateral canthus of eye to gonium on the same
side
- Tragus to corner of mouth on the same side
- Pain: Visual analogue scale (1-100) will be
used to document the level of pain the patient is feeling (1 being the
least pain and 100 being the most pain)
- Mouth opening: The distance between the upper
right and lower right central incisors will be measured with a scale (cm).
These parameters will be
measured and documented across 4 time points:
- Pre-operative (POD 0)
- First post-operative day (POD 1)
- Third post-operative day (POD 3)
- Seventh post-operative day (POD 7)
Additionally, patients will be asked to record the
number of additional analgesics they are taking. We will also assess and compare any inferior alveolar and/or
lingual nerve injury (hypoesthesia/ paresthesia/ anaesthesia) that may have
occurred on either side. This assessment will be done with the help of fine
touch and two-point discrimination tests. On
the 7th post-operative day, soft tissue healing will be evaluated
for both the groups in terms of persistent signs of inflammation, wound
dehiscence, and dry socket. |