Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06228612 |
| Other study ID # |
A12060922 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 20, 2021 |
| Est. completion date |
November 17, 2023 |
Study information
| Verified date |
December 2020 |
| Source |
Mansoura University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The aim of this study was to determine and compare the clinical efficacy of VT and STT alone
or in combination for the patients with temporo-mandibular joint (TMJ) osteoarthritis.
Description:
Study design and patients´ selection:
This prospective parallel randomized clinical trial included patients diagnosed with TMJ
osteoarthritis. All Patients were collected from the TMD clinic of Prosthodontics Department,
Faculty of Dentistry, Mansoura University. The study was approved by the local ethics
committee with ethical approval number A12060922. All patients were aware of the treatment
procedures and signed informed consents for their participation. Patients were recruited and
data collection was performed between . CONSORT guidelines were followed when approperiate19
Inclusion and exclusion criteria were defined prior to the beginning of the study. Inclusion
criteria were: (I) clinical diagnosis of TMJ osteoatrhritis according to diagnostic criteria
involved in the DC/TMD axis I group 3.A.2 item20 including self-report of TMJ pain,
tenderness to palpation, and crepitus (II) magnetic resonance imaging (MRI)signs of joint
effusion, erosions and ⁄ or sclerosis of the cortical outline, flattening of the joint
surfaces and ⁄ or osteophyte formation ; and (III) age cognitively capable of understanding
the standardized questionnaire.
Exclusion criteria were: (I) Patients with systemic disease affecting the joints (II)
previous TMJ treatment, (III) previous trauma to TMJ or to the jaws, and (IV) edentulous
patients, (V) use of anti-inflammatory drugs at least one month before assessment and during
the treatment period.
Sample size calculation:
Sample size calculation was performed by using G*Power software (version 3.1.9.7) based on
previous study by El-Shaheed et al.21 A medium effect size (f = 0.25) for interaction effect
of treatment group and time on quantitative outcomes (amount of mouth opening in mm,
temporo-mandibular joint palpation and VAS score for pain) and a large effect size (f = 0.4)
for main group effect on these outcome measures were hypothesised. Based on these
assumptions, a total sample size of 42 (14 in each treatment group) achieved 83% power to
detect a large effect size (f = 0.4) with 0.05 α-error probability using F test anova:
Repeated measures, between factors for three groups and five measurements with a .5
correlation between measurements.
Patients' randomization:
Patients who are eligible in this study after screening phase and who agree to sign the
consent form were randomly assigned to grouping. Patient's randomization was performed by two
assistants who did not participate in the trial. One assistant had prepared sequentially
numbered sealed envelopes with random assignment. The assignment of the treatment was then
completed by another assistant from outside the trial. Patients whose treatment plans
included vacuum therapy (VT) were designated group (I) and included 14 patients, and those
with stabilization splint therapy (SST) were designated (group (II) and included 14 patients.
Patients whose treatment plans included both vacuum therapy and splint therapy (VT + SST)
were designated as group (III) and included 14 patients.
Intervention:
The treatments were applied by an experienced dentist, with the necessary training in TMD
specialty.
For group (I) (VT group), vacuum therapy was applied over the TMJ. Before intervention, all
patients were informed about initial suction sensation and possible appearance of bruising at
the application site. Basic vacuum therapy equipment (cangexia, China) was utilized including
a manual suction pump, plastic cups of 40 mm diameter with rolled edge, and anti-septic
tools. The cup can be fixed by means of fixation gel () before application of the cup as hair
might interfere with the cup peripheral seal. Dry vacuum therapy was accomplished by
application of constant negative pressure of 300 mbar (which is equal to two suctions) using
the manual suction pump through the suction cup over the TMJ region for 5 minutes22 (Fig.1).
Whether any extra oral muscle showed pain, vacuum therapy application was performed using the
same protocol. After completing the procedures, an anti-septic solution was placed over the
vacuum application site (sites). All patients in this group were treated one session per week
for four successive weeks (Fig.2).
For group (II) (ST group), A maxillary stabilization splint (MSS) was constructed for each
patient from hard, heat-cured clear acrylic resin and fitted to the maxillary teeth. On the
mounted master casts, the vertical dimension was adjusted to provide 3 mm of vertical space
between the closest opposing cusps of the maxillary and mandibular teeth. The occlusal
contact of the splint was adjusted to provide even simultaneous contact with the opposing
mandibular cusps in the treatment position. the mandibular canines provide laterotrusive
guidance in lateral exertions (canine guidance), and mandibular anterior teeth provide
anterior contact and posterior disocclusion (anterior guidance). After processing, the splint
was fitted on the maxillary arch and adjusted if needed (Fig.3). Patients were advised to
wear it 12 hours per day for six months. Patients were recalled regularly for occlusal
readjustment of the splint.
For group (III) (VT+SST), both VT and SST were started at the same day. Procedures were the
same as in group I and II.
Collagen hydrolysate
Patients' evaluation:
Patients' evaluation was performed by an experienced independent researcher who did not
participate in other procedures in this study and was blinded to all intervention groups.
I- Clinical evaluation:
Patients were evaluated regarding their TMJ signs and symptoms at base line (T0), one week
(Tw), one month (T1), three months (T3), and six months (T6):
1. Maximum comfortable mouth opening (MCO) was measured using millimeter ruler between the
incisal edges plus the overbite while the patient opens at maximum comfortable opening.
2. The degree of pain was evaluated using 0 to10 mm Visual Analogue Scale (VAS) for pain
(where 0 equals no pain and 10 is the most severe pain).
3. TMJ tenderness on palpation was assessed by Verbal Rating Scale (VRS) using firm and
constant pressure of half kg lasted two seconds over the condyle in front of the tragus.
The degree of joint tenderness was extended from 0 to 3 (0: no; 1: slight; 2: moderate;
3: severe).
4. Joint sound was detected using stethoscope
5. Change perception was assessed at Tw, T1, T3, and T6 with the Patient Global Impression
of Change Scale (PGICS) which evaluates the change perceived by the patients after
treatment. This scale has seven affirmations depicting a patient's rating of overall
improvement (1 "very much improved", 2 "much improved", 3 "minimally improved", 4 "no
change", 5 "minimally worse", 6 "much worse", or 7 "very much worse").
6. Any side effects from either treatments also had been reported.
