| 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
|
|
|
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 low intensity 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 low intensity pulsed ultrasound
(LIPUS) and low intensity laser therapy (LILT) , it remains an under studied 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
low intensity pulsed
ultrasound and low intensity laser
therapy on wound healing following removal of an third molar.1 |