| CTRI Number |
CTRI/2019/01/017021 [Registered on: 09/01/2019] Trial Registered Prospectively |
| Last Modified On: |
08/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Diagnostic
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To assess the effect of pain reduction in Temporo Mandibular Joint using Pulsed Electro Magnetic Field Therapy in patients with malaligned teeth.
|
|
Scientific Title of Study
|
Assessment of Efficacy of Pulsed Electromagnetic Field therapy on Temporo Mandibular Joint Pain in patients with Malocclusion. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MADC/IRB-XXIII/2018/370 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr ABINAYA S |
| Designation |
Postgraduate student (MDS) |
| Affiliation |
Meenakshi Ammal Dental College and Hospital |
| Address |
1/54, DHANAM NAGAR, MUGALIVAKKAM,
PORUR,
CHENNAI.
Kancheepuram
TAMIL NADU
600125
India |
| Phone |
8807768610 |
| Fax |
|
| Email |
abi.kandhan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr NAGACHANDRAN K S |
| Designation |
Reader and Guide |
| Affiliation |
Meenakshi Ammal Dental College and Hospital |
| Address |
Department of Orthodontics,
Meenakshi Ammal Dental College and Hospital,
Alapakkam main road,
Maduravoyal,
chennai.
Chennai
TAMIL NADU
600095
India |
| Phone |
09884152660 |
| Fax |
|
| Email |
orthoksn@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr NAGACHANDRAN K S |
| Designation |
Reader and Guide |
| Affiliation |
Meenakshi Ammal Dental College and Hospital |
| Address |
Department of Orthodontics,
Meenakshi Ammal Dental College and Hospital,
Alapakkam main road,
Maduravoyal,
chennai.
Chennai
TAMIL NADU
600095
India |
| Phone |
09884152660 |
| Fax |
|
| Email |
orthoksn@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Meenakshi Ammal Dental College and Hospital,
Alapakkam main road, Maduravoyal, Chennai-95 |
|
|
Primary Sponsor
|
| Name |
Dr ABINAYA S |
| Address |
1/54, DHANAM NAGAR,
MUGALIVAKKAM,
PORUR,
CHENNAI,
TAMILNADU - 600125. |
| Type of Sponsor |
Other [SELF] |
|
|
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 ABINAYA S |
MEENAKSHI AMMAL DENTAL COLLEGE AND HOSPITAL |
Alapakkam main road,
Maduravoyal,
Chennai-95
Chennai
TAMIL NADU |
8807768610
abi.kandhan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL REVIEW BOARD |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M266||Temporomandibular joint disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional splint therapy |
Frequency of wear - around 6 to 8 hours per day during night time.
Duration - around 21 to 45 days. |
| Intervention |
Conventional splint therapy with Pulsed Electromagnetic Field Therapy.
|
Frequency of wear - around 6 to 8 hours per day during night time.
Duration - around 21 to 45 days. |
|
|
Inclusion Criteria
|
| Age From |
17.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1) Ambulatory patients with malocclusion who requires fixed orthodontic treatment.
2) Individuals with clinically evident jaw deviation during mouth opening associated with pain in one or both the TM joints – diagnosis based on RDC.
3) With or without clicking sounds in the TMJ region.
4) Absence of one or more teeth.
|
|
| ExclusionCriteria |
| Details |
1) Systemic illnesses, no cardiac disease, no pacemaker, or other conditions that could be affected by radio frequency discharge beams.
2) Presence of local infection or any other dental pain.
3) Prosthetic joint replacement or placement of any metallic surgical device in or around the area of treatment.
4) Interarticular steroid injection in the past three months.
5) Any medical or psychological disorder that might affect the pain threshold.
6) Constant dose of NSAID or narcotic analgesic drugs
7) Other therapeutic modality during the period of the study.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| significant pain relief after conventional splint therapy along with active PEMF therapy |
every 2 weeks for 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| using PEMF as an effective non-invasive adjunct method of treatment for pain in TMJ. |
6 weeks |
|
|
Target Sample Size
|
Total Sample Size="134"
Sample Size from India="134"
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 |
|
Date of First Enrollment (India)
|
28/01/2019 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This
study is a randomized, prospective clinical
trial to assess the efficacy of Pulsed
Electro Magnetic Field (PEMF) therapy in patients with malocclusion associated
with pain in the Temporo-Mandibular joint (TMJ) region. The study includes a sample
size of 134 subjects, with pain in the TMJ region, who will be diagnosed based
on Research Diagnostic Criteria (RDC), reporting to Meenakshi Ammal Dental
College, Chennai, Tamilnadu, India.
Patients
who meet the selection criteria will be randomly divided into two study groups
namely Group – I (Control group) and Group – II (Experimental group) with 67patients in each group. In Group-I,
patients will be treated with conventional splint therapy. In Group- II, patients
will be provided with conventional splint therapy along with active PEMF
therapy. The frequency of wear of the device will be around 6-8 hours per day
during night time with duration of around 21 to 45 days. In both the groups,
the patients will be evaluated for the pain relief using the assessment scale
(universal pain assessment tool) at the following intervals: T0 (before device
insertion), T1 (after 2 weeks), T2 (after 4 weeks) and T3 (after 6 weeks). After 6 weeks, effectiveness of treatment and
post treatment changes will be evaluated using patient’s global impression of
change (PGIC) scale.
The outcome of the study is to assess significant
pain relief after conventional splint therapy along with active PEMF therapy
and to validate the use of PEMF as an effective non-invasive adjunct method of
treatment for pain in TMJ region in patients with malocclusion. |