| CTRI Number |
CTRI/2018/03/012471 [Registered on: 12/03/2018] Trial Registered Prospectively |
| Last Modified On: |
09/03/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Injection to treat joint problem in face |
|
Scientific Title of Study
|
To assess the efficacy of prolotherapy in management of temporomandibular joint dysfunction. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Priyadarshini S |
| Designation |
Post Graduate Trainee |
| Affiliation |
SRM Dental college and hospital |
| Address |
Department of oral and maxillofacial surgery
SRM Dental college and hospital
Bharathi salai ramapuram
chennai-89
Chennai
TAMIL NADU
600089
India |
| Phone |
9791488160 |
| Fax |
|
| Email |
khanshahkhan786@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
sasikala B |
| Designation |
Reader |
| Affiliation |
srm dental college and hospital |
| Address |
Department of oral and maxillofacial surgery
SRM Dental college and hospital
Bharathi salai ramapuram
chennai-89
Chennai
TAMIL NADU
600089
India |
| Phone |
9840495547 |
| Fax |
|
| Email |
sasiomfs@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
sasikala B |
| Designation |
Reader |
| Affiliation |
SRM Dental collegeand hospital |
| Address |
Department of oral and maxillofacial surgery
SRM Dental college and hospital
Bharathi salai ramapuram
chennai-89
Chennai
TAMIL NADU
600089
India |
| Phone |
9840495547 |
| Fax |
|
| Email |
sasiomfs@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of oral and maxillofacial surgery
SRM Dental college and hospital
Bharathi salai ramapuram
Chennai tamilnadu |
|
|
Primary Sponsor
|
| Name |
Priyadarshini S |
| Address |
Department of oral and maxillofacial surgery
SRM Dental college and hospital
bharathi salai ramapuram
Chennai tamilnadu |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Priyadarshini S |
Department of oral and maxillofacial surgery SRM Dental college and hospital |
Department of oral and maxillofacial surgery SRM Dental college and hospital Ramapuram Chennai
TAMILNADU
Chennai
TAMIL NADU |
9791488160
khanshahkhan786@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 |
TMJ dysfunction patients, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Acrylic splints |
Anterior bite plant splint
posterior bite plane splints |
| Intervention |
prolotherapy agent
|
dextrose
bacteriostatic water
lignocaine with adrenaline
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient with age group between 18 to 60 yrs, having Temporomandibular joint pain and clicking and not having any systemic and metabolic diseases |
|
| ExclusionCriteria |
| Details |
Patients having any systemic or metabolic diseases, Allergic to corn products, long term use of high doses of systemic steroids, patients age above 60 yrs and below 18 yrs and not having any TMJ pain and clicking |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To reduce pain and improve mouth opening |
1st day-first injection
2nd week
4th week
6th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of reduction in pain and improvement in mouth opening |
Every 2 weeks up to 2 months after last injection for study group
Every 2 weeks up to 2 months after delivering of splints for control group
|
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
02/04/2018 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Various treatment modalities are available for the management of temporomandibular joint dysfunction.They can be conservatively managed or may require surgical intervention.one of the speculated etiology of the temporomandibular joint disorder is laxity of the tendons and ligaments. Prolotherapy of Temporomandibular joint stimulates the growth of the ligaments.The technique is simple and less invasive and cost effective. only few studies have been done in temporomandibular joint disorder using prolotherapy. Hence this study is done to evaluate the effectiveness of prolotherapy in temporomandibular joint disorder patients. |