| CTRI Number |
CTRI/2025/08/093303 [Registered on: 20/08/2025] Trial Registered Prospectively |
| Last Modified On: |
14/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparing two different instruments used for intraoral incision in oral major surgical procedures - A clinical trial |
|
Scientific Title of Study
|
Comparison of the effectiveness of stainless-steel scalpel and electrocautery in oral mucoperiosteal incision wound outcome, in oral major surgical procedure – A 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 |
Saraswathi Lakshmi Yatam |
| Designation |
Post Graduate student |
| Affiliation |
Amrita Vishwa Vidyapeetham Amrita School of Dentistry |
| Address |
Department of Oral and Maxillofacial surgery, amrita school of dentistry, Ground floor, Room no - 2, AIMS PO., Edapally, Kochi - 682041, Kerala.
Department of Oral and Maxillofacial surgery, amrita school of dentistry, Ground floor, Room no - 2 AIMS PO., Edapally, Kochi - 682041, Kerala.
Ernakulam
KERALA
682041
India |
| Phone |
07708160312 |
| Fax |
|
| Email |
yatamsaraswathi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Ravi Veeraraghavan |
| Designation |
Professor |
| Affiliation |
Amrita Vishwa Vidyapeetham Amrita School of Dentistry |
| Address |
Department of Oral and Maxillofacial Surgery, Amrita School of dentistry, Ground Floor, Room No - 2, AIMS PO., Edapally, Kochi - 682041, Kerala.
Department of Oral and Maxillofacial Surgery, Amrita School of dentistry, Ground Floor, Room No - 2, AIMS PO., Edapally, Kochi - 682041, Kerala.
Ernakulam
KERALA
682041
India |
| Phone |
07708160312 |
| Fax |
|
| Email |
dr.ravi.omfs@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Saraswathi Lakshmi Yatam |
| Designation |
Post Graduate student |
| Affiliation |
Amrita Vishwa Vidyapeetham Amrita School of Dentistry |
| Address |
Department of Oral and Maxillofacial Surgery, Amrita School of dentistry, Ground Floor, Room No - 2, AIMS PO., Edapally, Kochi - 682041, Kerala.
Department of Oral and Maxillofacial Surgery, Amrita School of dentistry, Ground Floor, Room No - 2, AIMS PO., Edapally, Kochi - 682041, Kerala.
Ernakulam
KERALA
682041
India |
| Phone |
07708160312 |
| Fax |
|
| Email |
yatamsaraswathi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Amrita Vishwa Vidyapeetham, Amrita School of dentistry, Ground Floor, Room No - 2, AIMS PO., Edapally, Kochi - 682041, Kerala. |
|
|
Primary Sponsor
|
| Name |
Saraswathi Lakshmi Yatam |
| Address |
AIMS PO Edapally Kochi 682041, Kerala |
| 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 |
| Saraswathi Lakshmi Yatam |
Amrita Vishwa Vidyapeetham Amrita School of Dentistry |
Deparmtment of oral and maxillofacial surgery, Ground floor, Room no 2, AIMS PO Edappally 682042 Kochi
Ernakulam
KERALA |
07708160312
yatamsaraswathi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Amrita School of Medicine |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Electrocautery and
Scalpel |
Comparing the effectiveness of oral mucoperiosteal incision using stainless steel scalpel and electrocautery in major oral surgical procedures. Here comparator agents are electrocautery and scalpel. |
| Intervention |
Electrocautery and scalpel |
Patients will be selected randomly into two groups, both of which will undergo major oral surgical procedures. In the first group oral mucosal incision will be placed using electrocautery. In the second group oral mucosal incision will be placed using stainless steel scalpel. At the time of incision bleeding and time taken for incision will be assessed. Post-operatively wound healing and pain assessment will be measured at intervals of 1st, 3rd, 7th, and 10th postoperative days. Mucosal scarring index will be measured at 3 months postoperatively. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients who require oral vestibular incision for management and correction of any facial deficits.
Orthognathic surgical procedures which require intra-oral vestibular incision.
Oral and maxillofacial pathologies involving only hard tissue which require intra-oral mucosal incisions.
Patient more than 18 years old.
Healthy patients, ASA I & II.
|
|
| ExclusionCriteria |
| Details |
Medically compromised patients such as patients with history of bleeding disorder, collagen disorder, diabetes, hypertension, ASA III, IV, V, VI.
Presence of bone fractures in the region.
Presence of pathology along the line of incision.
Presence of intra oral laceration/wound in the site of incision.
Presence of ecchymosis in the site of incision.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of electrocautery and stainless-steel scalpel incisions in oral surgical procedures in terms of time taken for incision, healing efficacy, blood loss, post operative pain assessment, scar formation. |
Time taken for incision and bleeding measured at baseline during surgery.
Post-operative pain, healing efficacy measured within 2 weeks after surgery.
Mucosal scarring index measured within 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="26"
Sample Size from India="26"
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)
|
09/09/2025 |
| 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="0"
Months="2"
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
|
Precise incisions are essential in oral and maxillofacial surgery where controlled access and optimal healing are critical for successful outcomes. Scalpel blades are traditionally used for oral incision which offers refined cutting precision but poses challenges such as bleeding and the need for additional hemostatic measure. Alternative source to achieve hemostasis was electrocautery. This results in cauterizing the blood vessels in the surgical site and provides a bloodless field. Although numerous studies have investigated parameters such as blood loss, incision time and healing for both technique the impact on scar formation remains underexplored. This study aims to compare the effectiveness of electrocautery and scalpel based on fate of incision by assessing the scar formation, bleeding, wound healing, pain and time taken for incision. The study design is randomized clinical trial with sample size of 26. Inclusion criteria are patients who require oral vestibular incision for management and correction of any facial deficits, orthognathic surgical procedures which require intra oral vestibular incision, Oral and Maxillofacial pathologies involving only hard tissue which require intra-oral mucosal incision, patient more than 18 years old, healthy patients under ASA I and II. Exclusion criteria include medically compromised patients such as patients with history of bleeding disorder, collagen disorder, diabetes, hypertension, ASA III, IV, V and VI, presence of bone fractures in the region, presence of pathology along the line of incision, presence of intraoral laceration or wound in the site of incision, presence of ecchymosis in the site of incision. |