| CTRI Number |
CTRI/2025/02/079965 [Registered on: 06/02/2025] Trial Registered Prospectively |
| Last Modified On: |
28/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Comparative Assessment of Effectiveness of Transcutaneous Electric Nerve Stimulation and Low-Intensity Pulsed Ultrasound for Reducing Pain associated with orthodontic tooth movement : A Randomized Controlled Trial
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Scientific Title of Study
|
A Comparison of Efficiency of Transcutaneous Electric Nerve Stimulation and Low-Intensity Pulsed Ultrasound for Reducing Pain associated with orthodontic tooth movement : A Randomized Controlled 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 Ankita Mandavia |
| Designation |
MDS student |
| Affiliation |
Manubhai Patel Dental College and Dental Hospital and SSR General Hospital Gujarat |
| Address |
Department of orthodontics and dentofacial orthopedics, Manubhai Patel Dental college and hospital, Vishwajyoti Ashram Near. Vidyakunj School, Muj Mahuda, Vadodara,
Gujarat
390011
Vadodara
GUJARAT
390011
India |
| Phone |
9664999843 |
| Fax |
|
| Email |
ankita.mandavia5@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Udita Thakkar |
| Designation |
Reader |
| Affiliation |
Manubhai Patel Dental College and Dental Hospital and SSR General Hospital Gujarat |
| Address |
Department of orthodontics and dentofacial orthopedics, Manubhai Patel Dental college and hospital, Vishwajyoti Ashram Near. Vidyakunj School, Muj Mahuda, Vadodara, Gujarat 390011
Vadodara
GUJARAT
390011
India |
| Phone |
9930368534 |
| Fax |
|
| Email |
druditamehta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ankita Mandavia |
| Designation |
MDS Student |
| Affiliation |
Manubhai Patel Dental College and Dental Hospital and SSR General Hospital Gujarat |
| Address |
Krishna Nagar street no 3, near rajkamal store, Madhuvan, jamnagar
Jamnagar
GUJARAT
361006
India |
| Phone |
09664999843 |
| Fax |
|
| Email |
ankita.mandavia5@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Orthodontics and Dentofacial Orthopedics, Manubhai Patel Dental college and Hospital, Vadodara, Gujrat, India-390011 |
|
|
Primary Sponsor
|
| Name |
Dr Ankita Mandavia |
| Address |
Krishna Nagar street no 3 near Rajkamal store Madhuvan, jamnagar, 361006 |
| Type of Sponsor |
Other [SELF] |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ankita Mandavia |
Manubhai Patel Dental college and Hospital, Vadodara, Gujrat |
Department of orthodontics and dentofacial orthopedics, Manubhai Patel Dental college and hospital, Vishwajyoti Ashram Near. Vidyakunj School, Muj Mahuda, Vadodara, Gujarat 390011
Vadodara
GUJARAT |
09664999843
ankita.mandavia5@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE (IEC) FOR REASERCH |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Low-Intensity Pulsed Ultrasound |
After placement of Separator Low-Intensity Pulsed Ultrasound therapy given on either side for consecutive 2 days |
| Comparator Agent |
Separator placement |
After placement of Separator no any type of Therapy given |
| Intervention |
Transcutaneous Electric Nerve Stimulation |
After placement of Separator Transcutaneous Electric Nerve Stimulation given on either side for consecutive 2 days |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
Patients receiving fixed orthodontic treatment.
Patients in age group of 18-35 years
Absence of spacing, presence of tight contacts between the permanent first molar and adjacent teeth.
Intake of no systemic analgesics.
Presence of antagonistic tooth.
Absence of posterior open bite.
Good oral hygiene and healthy periodontium.
|
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| ExclusionCriteria |
| Details |
Patients who do not give consent for the study.
Patients under pain or anxiety medications.
Patients with compromised periodontium.
Patients with Migraine
Patients whose pain will not relieved after 2 cycle of TENS and US therapy.
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
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Method of Concealment
|
An Open list of random numbers |
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Blinding/Masking
|
Participant Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| To assess the pain level associated with orthodontic tooth movement after Separator placement |
4 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the pain level associated with orthodontic tooth movement after giving Transcutaneous Electric Nerve Stimulation or Low-Intensity Pulsed Ultrasound Therapy for consecutive 2 days after Separator placement |
4 Days |
|
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Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
17/02/2025 |
| 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)
|
Open to Recruitment |
| 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
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Brief Summary
|
This will be a in-vivo study. 66 patients undergoing orthodontic treatment will be selected for the study. The study protocol will be verbally explained and a consent form will obtained from the patients and only those willing are going to include in the study. For all subjects elastic separators (Ortho Organizer Inc.) will be placed mesially and distally to both maxillary first molar by using elastomeric separating pliers.
The TENS device used in this study is designed by UltraCare PRO (Zealmax Innovations Pvt. Ltd, Gujarat, India). It is a dual-channel rechargeable TENS unit made for pain relief and has a compact, portable design made for easy operation with four reusable self-adhesive electrode pads to be used. Patient will further informed about a pain-relieving gadget that delivered a modest electric current and also the stimulus might be anything from sub-sensory to a little tingle.Immediately after placement of separator a self adhesive electrode pads will be placed on the subjects zygomatic arch. TENS unit will be set to deliver a current frequency of 0.5 Hz with an intensity of 500 mA. The duration of each Session will be 20 minutes. The same procedure will repeat after 24 hours. Low-Intensity Pulsed Ultrasound(Medgears Digital Unit Ultrasound Physiotherapy Machine-Tapsi CYCLOPS 1) will be used on other group of patients. First, a small amount of gel applies to the outer surface of facial skin than moves the Ultrasound Machine Head in small circular direction over area of zygomatic arch for 7 min. The output frequency of the device will be 1 MHz, The maximum output power will be 3 W/cm2 in the pulse mode. The same procedure will get repeat after 24 hours. •Following the separator placement and giving TENS therapy or Ultra sound therapy , each subject will get VAS scoring slips(Figure-4) and instructed to evaluate their pain every 12 hours by marking the spot on the line they believed to best represent the pain they will experiencing at that time for 4 days.
The VAS Scale is 10-cm line labelled at each end by descriptor such as ‘no pain’ and ‘worst pain’.
Subjects will be also instructed to make each evaluation independently from the previous ones by not consulting the previous VAS ratings.
Patient will be asked to set 12 hours alarm for reminder and after filling form every 12 hours send the confirmation message on WhatsApp.
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