| CTRI Number |
CTRI/2020/12/029524 [Registered on: 03/12/2020] Trial Registered Prospectively |
| Last Modified On: |
19/11/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A randomized control trial comparing the efficacy of joint lavage ,mandibular manipulation and anterior repositioning splint versus joint lavage and mandibular manipulation in management of temporomandibular disc displacement without reduction |
|
Scientific Title of Study
|
A randomized clinical trial comparing the efficacy of arthrocentesis with
mandibular manipulation and anterior repositioning splint versus arthrocentesis
and mandibular manipulation in the management of temporomandibular joint disc
displacement without reduction |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR ONGKILA BHUTIA |
| Designation |
Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
room no : 106
First floor
Division of Oral and Maxillofacial Surgery
Centre for Dental Education and Research
All India Institute of Medical Sciences, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9313349564 |
| Fax |
|
| Email |
psongkilabhutia@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anuvindha J S |
| Designation |
Junior resident |
| Affiliation |
AIIMS, New Delhi |
| Address |
First floor ,Dept of Oral and Maxillofacial Surgery ,Centre of Dental Education and Research
AIIMS,New Delhi
New Delhi
DELHI
110029
India |
| Phone |
8590076580 |
| Fax |
|
| Email |
anuomfs1994@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anuvindha J S |
| Designation |
Junior resident |
| Affiliation |
AIIMS, New Delhi |
| Address |
First floor ,Dept of Oral and Maxillofacial Surgery ,Centre of Dental Education and Research
AIIMS,New Delhi
New Delhi
DELHI
110029
India |
| Phone |
8590076580 |
| Fax |
|
| Email |
anuomfs1994@gmail.com |
|
|
Source of Monetary or Material Support
|
| Division of oral and maxillofacial surgery
Centre for dental education and research
AIIMS,NEW DELHI |
|
|
Primary Sponsor
|
| Name |
Division of oral and maxillofacial surgery |
| Address |
Centre for dental education and
research
AIIMS, NEW DELHI |
| 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 |
| DR ANUVINDHA J S |
DEPT OF ORAL AND MAXILLOFACIAL SURGERY |
ROOM NO : 21
FIRST FLOOR
DIVISION OF ORAL AND MAXILLOFACIAL SURGERY
CENTRE FOR DENTAL EDUCATION AND RESEARCH
AIIMS, NEW DELHI
New Delhi
DELHI |
8590076580
anuomfs1994@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institute ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
ASA 1 PATIENTS WITH TMD PROBLEM WILKES CLASSIFICATION 3 |
| Patients |
(1) ICD-10 Condition: M266||Temporomandibular joint disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
GROUP 1 - ARTHROCENTESIS, MANDIBULAR MANIPULATION |
STEP 1 Arthrocentesis (superior joint space)
The surgical site will be disinfected with povidone iodine (betadine) and covered with
sterile drapes. 2% lignocaine hydrochloride solution containing epinephrine (1: 2,00,000)
will be used for blocking the auriculotemporal nerve. The same local anaesthetic agent
will be also infiltrated into the joint cavity, skin surface and soft tissue over the joint. A
reference line will be drawn from the 10mm from middle of the tragus to the outer
canthus of the eye. The two points for needle insertion will be marked (as described by
Nitzan). The posterior entrance point will be marked at a point 10mm from the middle of
the tragus and 2mm below the canthotragal line. The anterior entrance point will be
placed 10mm further forward along the line and 10mm below it. 18gauge needles will be
inserted into the two points directed towards the superior joint space and lavage will be
performed using 100ml ringer lactate solution through one needle ensuring a free flow of
lavage through other needle. The mandible will then be manipulated gently to free the
disc further.
STEP 2. Mandibular Manipulation
Mandibular manipulation will be done by placing both the thumbs directly onto the
bilateral molars of the patient and pressed lightly downward or downward contralaterally.
The patient will be instructed to open the mouth as wide as possible simultaneously and
bring the mandible in protruded edge to edge bite position with mouth closed. An audible
click along with maximum unassisted mouth opening or unassisted mouth opening with
bilateral condylar translation without any sound will be considered as the clinical criteria
of successful mandibular manipulation. |
| Intervention |
Group 2- Arthrocentesis, mandibular manipulation and ARS is done in a sequential
combination then clinical and MRI evaluation to be done during follow up.
|
STEP 1 Arthrocentesis (superior joint space)67,68
The surgical site will be disinfected with povidone iodine (betadine) and covered with
sterile drapes. 2% lignocaine hydrochloride solution containing epinephrine (1: 2,00,000)
will be used for blocking the auriculotemporal nerve. The same local anaesthetic agent
will be also infiltrated into the joint cavity, skin surface and soft tissue over the joint. A
reference line will be drawn from the 10mm from middle of the tragus to the outer
canthus of the eye. The two points for needle insertion will be marked (as described by
Nitzan). The posterior entrance point will be marked at a point 10mm from the middle of
the tragus and 2mm below the canthotragal line. The anterior entrance point will be
placed 10mm further forward along the line and 10mm below it. 18gauge needles will be
inserted into the two points directed towards the superior joint space and lavage will be
performed using 100ml ringer lactate solution through one needle ensuring a free flow of
lavage through other needle. The mandible will then be manipulated gently to free the
disc further.
STEP 2. Mandibular Manipulation
Mandibular manipulation will be done by placing both the thumbs directly onto the
bilateral molars of the patient and pressed lightly downward or downward contralaterally.
The patient will be instructed to open the mouth as wide as possible simultaneously and
bring the mandible in protruded edge to edge bite position with mouth closed. An audible
click along with maximum unassisted mouth opening or unassisted mouth opening with
bilateral condylar translation without any sound will be considered as the clinical criteria
of successful mandibular manipulation.
STEP 3. Immediate chairside Anterior repositioning splint (ARS)
A maxillary full coverage acrylic ARS with occlusal indentation and anterior lingual
guiding ramps will be immediately fabricated after mandibular manipulation with the
mandible guided into the protrusive position. |
| Comparator Agent |
NONE |
NONE |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA I patients
• Wilkes class III – Anterior disc displacement without reduction as confirmed by
MRI
• Patient willing for informed consent and follow up.
|
|
| ExclusionCriteria |
| Details |
Prior surgical treatment for TMD
• Edentulous patients
• Age<15years
• Presence of occlusion conditions (anterior cross bite)
• Presence of TMJ pathology
• Any medical condition which contraindicate the mentioned intervention
• Patient ongoing chemo or radiotherapy
• Pregnant patient
• Patient not willing for informed consent and not coming for follow up
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare efficiency of arthrocentesis, mandibular manipulation and anterior
repositioning splint therapy versus that of arthrocentesis and mandibular manipulation in
Wilkes stage 3 temporomandibular disorders (TMDs) for management of pain after
procedure by using VAS score. |
Pre intervention
2 weeks ,1 mnonth, 3 months and 6 months after intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the change in disc condyle angle and condyle disc position (MRI
Evaluation) at 3 months follow up
1. To measure mouth opening (passive and assisted) at 2 weeks ,1 month, 3 months
and 6 months follow up.
2. To access the subjective chewing efficacy 2 weeks, 1month, 3 months and 6
months follow up.
3.To assess the clicking after 2 weeks, 1 month, 3 months and 6 months follow up. |
mri evaluation before intervention and 3 mnths after intervention
clinical evaluation before interventionand 2weeks,1 month ,3 months and 6 months after intervention |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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)
|
15/12/2020 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
A randomized clinical trial comparing the efficacy of arthrocentesis with mandibular manipulation and anterior repositioning splint versus arthrocentesis and mandibular manipulation in the management of temporomandibular joint disc displacement without reduction PRIMARY OBJECTIVE To compare efficiency of arthrocentesis, mandibular manipulation and anterior repositioning splint therapy versus that of arthrocentesis and mandibular manipulation in Wilkes stage 3 temporomandibular disorders (TMDs) for management of pain after procedure by using VAS score. SECONDARY OBJECTIVES To compare the two procedures for the following: • To assess the change in disc condyle angle and condyle disc position (MRI Evaluation) at 3 months follow up • To measure mouth opening (passive and assisted) at 2 weeks ,1 month, 3 months and 6 months follow up. • To access the subjective chewing efficacy 2 weeks, 1month, 3 months and 6 months follow up. • To assess the clicking after 2 weeks, 1 month, 3 months and 6 months follow up. |