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CTRI Number  CTRI/2025/08/093397 [Registered on: 21/08/2025] Trial Registered Prospectively
Last Modified On: 21/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device
Surgical/Anesthesia
Radiation Therapy
Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of Low-Intensity Ultrasound Versus Laser Therapy (LLLT) on Healing of Wound Following Surgical removal of Mandibular Third Molar : A randomized control study 
Scientific Title of Study   Comparison of effectiveness of Low-Intensity Pulsed Ultrasound (LIPUS) Versus Low Level Laser Therapy (LLLT) on Healing of Wound Following Surgical Extraction of Mandibular Third Molar A Randomized control 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 Vinita Patil  
Designation  Junior Resident 
Affiliation  Government dental college and hospital  
Address  118,Dept. of Oral and Maxillofacial Surgery, Government Dental College and Hospital,St. Georges hospital compound Pdmello road Fort 400001

Mumbai
MAHARASHTRA
400001
India 
Phone  09892360408  
Fax    
Email  vinitapatil1910@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Samir Khaire  
Designation  Associate professor  
Affiliation  Government dental college and hospital  
Address  118,Dept. of Oral and Maxillofacial Surgery, Government Dental College and Hospital,St. Georges hospital compound Pdmello road Fort 400001

Mumbai
MAHARASHTRA
400001
India 
Phone  9767887203  
Fax    
Email  sameerkhaire@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Vinita Patil  
Designation  Junior Resident 
Affiliation  Government dental college and hospital  
Address  118,Dept. of Oral and Maxillofacial Surgery, Government Dental College and Hospital,St. Georges hospital compound Pdmello road Fort 400001

Mumbai
MAHARASHTRA
400001
India 
Phone  9892360408  
Fax    
Email  vinitapatil1910@gmail.com  
 
Source of Monetary or Material Support  
Dr. Vinita Patil 118,Dept. of Oral and Maxillofacial Surgery, Government Dental College and Hospital,St. Georges hospital compound Pdmello road Fort 400001  
 
Primary Sponsor  
Name  Dr. Vinita Patil  
Address  102, Dnyan Darshan Niwas near Hanuman Mandir Dativali Diva 400612 
Type of Sponsor  Other [Junior Resident ] 
 
Details of Secondary Sponsor  
Name  Address 
Government Dental College and Hospital Mumbai   St. Georges hospital compound Pdmello road Fort 400001 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vinita Patil   Government Dental College and Hospital Mumbai  118, Dept of oral and maxillofacial surgery, GDCH,St. Georges hospital compound Pdmello road Fort 400001
Mumbai
MAHARASHTRA 
9892360408

vinitapatil1910@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethical committee of Government Dental College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  bilateral impacted third molars  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Low Level Laser Therapy (LLLT)   Low level laser therapy (Photo biomodulation), A Diode laser with 980 nm in continuous mode. Dosage of Laser– Power: 0.8 watt, Dose: 6 J/cm2, time: 60 s on day 1, 3, 7  
Intervention  Low-Intensity Pulsed Ultrasound (LIPUS)   LIPUS device with settings 1 MHz, pulsed 20 percentage and dose 1.0 watts/square centi-meter (W/cm2)/sham for day 1, 3,7  
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details 
Participants requiring bilateral surgical extractions of third molars in mandibular arch with
Pederson difficulty index of 5-6 (moderately difficult)
Patients with well controlled systemic conditions.
Participants willing to participate in study.
 
 
ExclusionCriteria 
Details  Pregnant , immunocompromised and syndromic patients
Patients with history of chronic substance abuse (alcohol, opiates, etc.)
Participants with history of cardiac surgeries, uncontrolled hypertension, uncontrolled diabetes, patients on anti-epileptic therapy, patients on medication for psychiatric illness (SSRIs, MAOs).
Participants not willing to participate in study
Participants unwilling/ unable to adhere to the follow up schedule
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate effect of LIPUS and LLLT on postoperative pain following mandibular third molar extraction using verbal rating scale.
To evaluate effect of LIPUS and LLLT on wound healing following mandibular third molar extraction using Landry’s index
 
1st , 3rd and 7th postoperative days.

 
 
Secondary Outcome  
Outcome  TimePoints 
• To evaluate effect of LIPUS and LLLT on swelling following mandibular third molar extraction using Gabka and Matsumara scale.
• To evaluate effect of LIPUS and LLLT on Trismus following mandibular third molar extraction using Vernier Calliper.
 
1st , 3rd and 7th postoperative days.
 
 
Target Sample Size   Total Sample Size="27"
Sample Size from India="27" 
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 3 
Date of First Enrollment (India)   01/09/2025 
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="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  

The surgical removal of mandibular third molars produces a significant degree of trauma to soft tissues and bony structures of oral cavity, resulting in release of inflammatory mediators.1 This produces postoperative signs and symptoms of pain, oedema and trismus, etc. Several therapeutic protocols such as use of various preoperative or postoperative antibiotic administration, different incisions, postoperative ice packs, corticosteroid administration by systemic, local or topical route are reported in literature for management of this postoperative sequelae and are constantly evolving.2

Accelerated healing after a surgical tooth extraction is important because it reduces the risk of infection, minimizes pain and discomfort, and facilitates faster recovery, allowing patients to resume normal activities sooner. Low level laser therapy and lowintensity pulsed ultrasound (LIPUS) are some of the more recently reported protocols that have been proven to reduce inflammatory mediators. Other methods for accelerated healing include topical melatonin application, platelet-rich fibrin (PRF) application, and axial micromovement, all of which have shown promise in promoting faster tissue regeneration and bone repair.

Laser is important in basic sciences, but mainly so in the diagnosis and treatment of the different pathologic conditions of the patients. It is electromagnetic radiation3 and is a source of light or radiation energy4; as it is not X-irradiation, it is not expected to produce a new generation of iatrogenic malignancies. Maiman described laser in the form of a ruby laser in

19605. LLL is a special type of laser that affects biologic systems through non-thermal means6. This area of investigation was initiated with the work of Mester et al. in 1967. Mester et al found the non-thermal properties of lasers on hair growth in mouse7. 

LLLT is the application of light to a biological tissue to promote tissue regeneration. It has a photochemical effect; according to this effect, the light is absorbed and causes a chemical change8. The reason behind why this technique is termed ‘low-level’ is because the optimal levels of dose provided are lower than other forms of laser therapy such as those practiced for ablation, cutting, and thermal tissue coagulation9.

Ultrasound can be defined as sound wave or pressure wave with a frequency  above the limit of the human hearing range(16–20 kHz).The unit of ultrasound is Hertz or cycle per second. Being a propagating pressure wave, ultrasound is capable of transferring mechanical energy into the tissues. The energy of the ultrasound signal is transferred, propagated, or reflected depending on its frequency.10

In the year 1976, Duarte first reported that LIPUS stimulated the growth of bone healing of fresh fracture in experimental cortical defects and fibular osteotomy in rabbits and non-unions in humans. Similar findings have been reported in treatment of osteoradionecrosis, tibial fractures, distal radial fractures with findings such as reduction in healing time by 38-41%. The acceleration of callus formation in diabetic fractures has also been reported.11

 LIPUS therapy has been widely accepted for enhancing endochondral bone formation.12 It has also been demonstrated to increase the blood flow near the injured area13. The therapeutic ultrasound used in LIPUS is harmless and does not require any subsequent surgeries14. It has been reported to have higher efficiency of the treatment, especially when it is performed in the initial stage of the impact. In addition, LIPUS treatment can be used along with the metallic fixtures, without causing any adverse side effects to the tissues.15 

Apart from the use in orthopedic field, the clinical application of ultrasound therapy has now been extended to healing of maxillofacial bones.16 Konno et al further reported that LIPUS increased the acceleration of callus formation in the stimulation side compared with the nonstimulation side.17 LIPUS increases bone mineralization and stimulates fracture repair by converting the cartilaginous soft callus into mineralized callus, improving the stability of fracture union.18

In case of ultrasound therapy, the mechanical stimulation inherent to ultrasound waves translates into a biological response. LIPUS waves create nano-motion at the fracture site, where the mechanical signal is converted into biochemical signals intracellularly. It stimulates the production of cyclooxygenase 2, which promotes prostaglandin E2 (PGE2) production. PGE2 triggers osteogenic genes, which facilitate mineralization and endochondral ossification, thereby aiding in bony healing.19

Despite several in vitro and in vivo applications of lowintensity pulsed ultrasound (LIPUS) and low intensity laser therapy (LILT) , it remains an understudied feature of the oral and maxillofacial region. Based on the understanding of the mechanism of LIPUS and LILT , it is the goal of this study to objectively investigate the efficacy of lowintensity pulsed ultrasound  and low intensity laser therapy on wound healing following removal of an third molar.1

 
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