| CTRI Number |
CTRI/2026/03/107002 [Registered on: 27/03/2026] Trial Registered Prospectively |
| Last Modified On: |
19/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Biological
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing Salt Water and Antiseptic Liquid Used During Wisdom Tooth Removal and How They Affect Healing. |
|
Scientific Title of Study
|
COMPARISON BETWEEN BENEFITS OF INTRA OPERATIVE NORMAL SALINE AND CHLORHEXIDINE IRRIGATION ON
POST SURGICAL HEALING AFTER SURGICAL EXTRACTION OF MANDIBULAR WISDOM MOLARS – A RANDOMISED CONTROL CLINICAL 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 |
Dr Kiholi S Kharsati |
| Designation |
post graduate student |
| Affiliation |
nair hospital dental college mumbai |
| Address |
107,Dept.of oral and maxillofacial surgery, Nair hospital dental college, Mumbai
Mumbai
MAHARASHTRA
400008
India |
| Phone |
9366236689 |
| Fax |
|
| Email |
kiholikharsati@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mohan DDeshpande |
| Designation |
Associate Professor |
| Affiliation |
nair hospital dental college,mumbai |
| Address |
107,Dept.of oral and maxillofacial surgery, Nair hospital dental college, Mumbai
Mumbai
MAHARASHTRA
400008
India |
| Phone |
7058020321 |
| Fax |
|
| Email |
mdd.nhdcos@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kiholi S Kharsati |
| Designation |
post graduate student |
| Affiliation |
nair hospital dental college mumbai |
| Address |
107,Dept.of oral and maxillofacial surgery, Nair hospital dental college, Mumbai
Mumbai
MAHARASHTRA
400008
India |
| Phone |
9366236689 |
| Fax |
|
| Email |
kiholikharsati@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dept.Oral and maxillofacial surgery Nair Hospital Dental College, Mumbai |
|
|
Primary Sponsor
|
| Name |
Nair Hospital Dental College Mumbai |
| Address |
Nair Hospital Dental College Mumbai, Mumbai central 400008 |
| Type of Sponsor |
Government 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 Kiholi S Kharsati |
Nair Hospital Dental College, Mumbai |
107,Dept.of oral and maxillofacial surgery, Nair hospital dental college, Mumbai
Mumbai
MAHARASHTRA |
9366236689
kiholikharsati@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC NHDC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
mandibular wisdom tooth pain |
| Patients |
(1) ICD-10 Condition: K011||Impacted teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
chlorhexidine irrigation |
Intraoperative irrigation of the surgical site with chlorhexidine solution during surgical extraction of mandibular third molar following standard surgical protocol. |
| Intervention |
normal saline |
Intraoperative irrigation of the surgical site with sterile normal saline during surgical extraction of mandibular third molar using standard surgical protocol. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. Individuals of consenting age falling into 18 - 40 age group
2. Individuals needing mandibular wisdom molar extractions of Class 1 Level A type (except distoangular type).
|
|
| ExclusionCriteria |
| Details |
1. Individuals with known H/O Hyperacidity, Peptic ulceration, Renal disease, Diabetes Mellitus, IHD, under antiplatelet , anticoagulant therapy and Bronchial asthma.
2. Mentally challenged patients.
3. Patients having local infection, pathology such as cyst or tumour associated with impacted Mandibular third molar.
4. Patients with previously radiated maxillofacial region.
5. Pregnant women, lactating mother, use of oral contraceptives.
6. Patients with compromised oral opening.
7.Patients having known allergy to study drugs.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pain assessment by VAS scale Swelling by local physical examination
Lymph nodes by local examination
Mouth opening by using ruler |
1st day before surgery
3rd day
7th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Alveolar osteitis by patient history and local examination |
3rd day
7th day |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/06/2026 |
| 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="6"
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 clinical study aims to compare the effectiveness of intraoperative irrigation with normal saline versus chlorhexidine on post-surgical healing following the surgical extraction of mandibular wisdom molars. The research evaluates key healing outcomes such as pain, swelling, infection, and overall tissue recovery in patients after surgery. By assessing and comparing these parameters between the two irrigation methods, the study seeks to determine which solution provides better post-operative healing and clinical benefits, thereby helping improve surgical protocols and patient recovery after third molar extraction. |