Comparison of the Efficacy of Single and Double Puncture Arthrocentesis in Treatment of Temporomandibular Joint Disc Displacement Without Reduction
Phase: NA
Conditions: Arthrocentesis
Sponsor: Erzincan University

Comparison of the Efficacy of Single and Double Puncture Arthrocentesis in Treatment 
of Temporomandibular Joint Disc Displacement Without Reduction
Date: 20/03/2020
This document contains study design and statistical analysis plan of the study entitled 
“Comparison of the Efficacy of Single and Double Puncture Arthrocentesis in Treatment of
Temporomandibular Joint Disc Displacement Without Reduction”.

Study Design:
This is a two-armed, randomized, parallel interventional clinical study enrolling 36 patients
with temporomandibular joint disc displacement without reduction (DDwoR). 
Eligibility:
Inclusion Criteria: 
•
Clinical  diagnosis  of  Temporomandibular  joint  (TMJ)  disc  displacement  without
reduction.
•
Restricted mouth opening
Exclusion criteria:
•
History of systemic disease effecting TMJ.
•
History of previous TMJ surgery
Patients  were  grouped  according  to  the  treatment  they  received:  Single  Puncture
Arthrocentesis as group SPA, Double Puncture Arthrocentesis as DPA. 
Double puncture arthrocentesis technique:
Posterior puncture method was used as described by Alkan and Etoz for DPA. A straight line
was drawn with a marker pen along the skin from the middle portion of the auricular tragus to
the lateral chantus. The first puncture point was marked 10 mm anterior and 2 mm inferior to
the tragus and the second 7 mm anterior and 2 mm inferior to the tragus. After local anesthesia,
upper joint cavity was irrigated with 200 mL of Lactated Ringer's (RL) solution by inserting
two 21- gauge needle. At the end of the procedure, after withdrawn of one of the needles, 1 mL
of sodium hyaluronate (SH) was injected into the upper TMJ compartment through the other
needle.
Single Puncture Arthrocentesis Technique:
SPA was performed with one needle (SPA Type-1 according to Senturk and Cambazoglu). The
first reference point in DPA was used as the needle entry point fort he SPA. With this technique,
the inflow and outflow of solution were provided through the same cannula and lumen of one
21-gauge needle as described by Guarda-Nardini et al. The joint was irrigated with 200 mL of
RL solution under high pressure. At the end of the procedure1 mL of SH was injected through

the needle
Outcome measures:
1. The Rate of Pain on Function (PoF) assessed by Numerical pain Scale (NRS)
Patients rated their pain on function (pain during chewing or speaking etc.) on a Numeric
Rating Scale (NRS) (0–10 where 0 is no pain and 10 is the worst pain imaginable).
Patients were evaluated at preoperatively and postoperatively 1st week, 1st month, 3rd month,
6th month.
2.  The measurement of pain-free maximum mouth opening (MMO) in millimeters: 
Pain-free MMO was measured as the distance between the incisal edges of the upper and lower
incisors by a caliper while patient’s mouth is open as possible without any assistance and
without pain in massater muscle. Three measurements were performed, and their average is
recorded. Patients were evaluated at preoperatively and postoperatively 1st week, 1st month,
3rd month, 6th month.
3.  The rate of pain at rest (PaR) assesed by Numerical pain Scale (NRS)
Patients  rated  their  pain  level  at  rest  on  a  Numerical  pain  Scale  (NRS)(0–10  where  0  is
no pain and  10  is  the  worst pain imaginable).  Patients  were  evaluated  at  preoperatively  and
postoperatively 1st week, 1st month, 3rd month, 6th month.
4.  Measurement of Duration of the Procedure in Minutes.
Total time for arthrocentesis was noted at the end of the procedure.
Patients were evaluated at the end of the procedure
5. Measurement of the easiness of the procedure to the operator by using Visual Analog
Scale (VAS):
The operator rated the degree of easiness of the procedure on a VAS as 0-very easy 10-very
difficult to perform at the end of the procedure
6. The rate of treatment tolerability assesed by 5-point Likert-type scale:
The degree to which overt adverse effects and post operative complications (pain,  feeling of
pressure in TMJ area and disturbing sound) can be tolerated by the patient. Patients were asked
to rate the tolerability on a 5 point scale as 0- lowest, 4-highest at operation day, 1st week, end
of follow up period (6th month)
7. The rate of chewing efficiency by using Visual Analog Scale (VAS):
Patients rated the chewing efficiency on a VAS as 0-can only eat semi-liquid foods, 10-eat any
solid-food. Patients were evaluated at preoperatively and postoperatively  1st week, 1st month,
3rd month, 6th month.

8.  Rate of perceived effectiveness of the treatment by using 5-point Likert-type scale:
Patients rated the subjective treatment effectiveness on a 5-point scale as 0- lowest, 4 highest
values at the end of the follow up period (6th month).
9. Measurement  of  Lateral  Movement  of  the  mandible  towards  the  affected
Temporomandibular joint (TMJ) in millimeters
Lateral Movement of the mandible towards the affected Temporomandibular joint (LT) was
measured as the distance between the midlines of the upper and lower incisors by a caliper
while patient’s mandible was shifted towards the affected TMJ. Three measurements were
performed,  and  their  average  is  recorded.  Patients  were  evaluated  at  preoperatively  and
postoperatively 1st week, 1st month, 3rd month, 6th month.
10. Measurement  of  Lateral  Movement  of  the  mandible  away  from  the  affected
Temporomandibular joint (TMJ) in millimeters
Lateral Movement of the mandible away from the affected Temporomandibular joint (LA) was
measured as the distance between the midlines of the upper and lower incisors by a caliper
while patient’s mandible was shifted away from the affected TMJ. Three measurements were
performed,  and  their  average  is  recorded.  Patients  were  evaluated  at  preoperatively  and
postoperatively 1st week, 1st month, 3rd month, 6th month.
11. Measurement of protrusive movement of the mandible in millimeters:
Protrusive movement of the mandible was measured as the distance in horizontal direction
between  the  incisal  edges  of  upper  and  lower  incisors  by  a  caliper  when  mandible  moves
forward. Patients were evaluated at preoperatively and postoperatively 1st week, 1st month, 3rd
month, 6th month.
Statistical Analysis:
IBM SPSS 22 was used to analyze the data (IBM SPSS Statistics for Windows, Version 22.0.
Armonk, NY: IBM Corp.). Descriptive statistics of the variables were presented as mean ±
standard deviation in statistical analysis. Normality of distribution for continuous variables was
evaluated  using  the  Kolmogorov-Simirnov  test.  Depending  on  whether  the  statistical
hypotheses were fulfilled, either the Student's t-test or the Mann–Whitney U test was used to
compare the independent continuous variables between the two groups, Wilcoxon signed rank
test was used for intra-group evaluation of variables according to baseline such as PoF ve
MMO. Statistical significance level was accepted as p <0.05.