Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000434594
Ethics application status
Approved
Date submitted
16/11/2023
Date registered
9/04/2024
Date last updated
9/04/2024
Date data sharing statement initially provided
9/04/2024
Date results information initially provided
9/04/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Efficacy of anti-inflammatory drugs in jaw-joint pain in edentulous patients.
Scientific title
Investigating the efficacy of anti-inflammatory drugs versus placebo medication in jaw-joint pain in edentulous patients applying nimesulide or parallel in dental prosthetic therapeutic steps.
Secondary ID [1] 310944 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Temporo-mandibular joint pain 332017 0
Other muscular or skeletal disorders 333083 0
Condition category
Condition code
Musculoskeletal 329777 329777 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1 conciders application of non-steroid antiinflammatory drug during clinical steps in fabrication of acrylic dentures for partially edentulous or edentulous patients with pain in temporomanibular jouint - **TMJ** The sort of thedrug to be administered is nimesulide or paralell (etophenamate, or ketoprofen) in the dose of 100 mg oral tablets once daily; The drug will be administered from the first time of the first clinical assessment until completion of fabrication of patient's acrylic dentures; Audit of medical records will be used to monitor adherence to the intervention,
Nimulid-Nimesulide was selected as the first medicament in this study. Nimesulide is the favorite in the therapy of pain joint due to the pharmacodynamic specifications that show Nimulide to be the anti-inflammatory non-steroidal drugs with minimum allergic reactions and side effects. This medicine can be obtained in some pharmacies even without a prescription. Dose of 100 mg per day is considered therapeutically harmless. In the case of allergy of the patient to NIMESULID alternative medications for pain relief in the temporomandibular joint are etophenamate or ketoprofen, which are anti-inflammatory anti-rheumatic drugs according to prescription.


Arm 2 regards prolonged application of non-steroid antiinflammatory drug after delivery of acrylic dentures and during recalls. The same sort of the medical - nimesulide or paralell (etophenamate, or ketoprofen) will be admistered in the form of 100 mg tablets once daily;Medicals will be administered from the insertion of acrylic dentures until follow-up after 8 weeks. Audit of medical records will be used to monitor adherence to the intervention..
Intervention code [1] 327374 0
Treatment: Drugs
Comparator / control treatment
The group of 30 partially edentulous patients and the group of 30 completely edentulous patients - 30 with symptoms and signs of pain TMJ will form the control group.
The composition of the placebo treatment is glucose capsule.
The duration of the administration will be from time of first clinical assessment until completion of fabrication of patient's acrylic dentures.
Oral tablets will be administered.
Control group
Placebo

Outcomes
Primary outcome [1] 336555 0
Change in TMJ pain.
Timepoint [1] 336555 0
Baseline, the moment of delivery and positioning of dentures onto supporting tissues in edentulous mouth, 3 months after initiation of the therapy, 6 months after initiation of the therapy and 9 months after therapy by acrylic dentures
Primary outcome [2] 336556 0
Change in TMJ pain
Timepoint [2] 336556 0
Baseline at the moment of delivery of dentures and strating therapy and rehabilitation of edentulous mouths of the patients,
after 3 months of wearing of dentures (in recalls) and after 3 months of wearing of dentures.
Primary outcome [3] 337190 0
Temporomandibular joint dysfunction assessed using the Helkimo dysfunction index.
Timepoint [3] 337190 0
Baseline at the moment of delivery of dentures and starting therapy and rehabilitation of edentulous mouths of the patients.
Secondary outcome [1] 428798 0
A composite secondary outcome is physiological movements of condyle , physiologic mobility of condyle and optimal non-pain condition of TMJ
Timepoint [1] 428798 0
Baseline and 9 months after therapy.

Eligibility
Key inclusion criteria
Partially edentulous patients or edentulous patients who need prosthetic rehabilitation with acrylic complete or partial dentures and who have acute or chronic pain in the one or two of TMJ-s.
Minimum age
41 Years
Maximum age
67 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The patients of the experimental groups :
Older participants with cardiac arrest or other cardiac disturbances;
Patients with history of allergic reaction to non-steriod antiinflammatory drug
Patients with liver disease
Patients with kidney disease
Patients with ulcus pepticus
Patients with cancer
Completely dentated subjects-subjects with all persistent natural teeth

The patients of the control group - This group of patients will be excluded from the therapy by antiinflamatory non-steroid drugs. They will not receive anti-inflammatory drugs because of previous allergic reactions in history, or because of liver or kidney diseases, or because of persistent ulcus pepticus in stomach, or because of previous history of stroke.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
15/10/2015
Date of last participant enrolment
Anticipated
Actual
4/09/2023
Date of last data collection
Anticipated
7/06/2024
Actual
Sample size
Target
90
Accrual to date
Final
90
Recruitment outside Australia
Country [1] 25963 0
Serbia and Montenegro
State/province [1] 25963 0
Serbia

Funding & Sponsors
Funding source category [1] 315962 0
Self funded/Unfunded
Name [1] 315962 0
Country [1] 315962 0
Primary sponsor type
Individual
Name
Srdjan D. Postic
Address
Clinic of Dental Prosthetic Rankeova street 4, 11000 Beograd, Serbia, Europe
Country
Serbia and Montenegro
Secondary sponsor category [1] 318104 0
None
Name [1] 318104 0
Address [1] 318104 0
Country [1] 318104 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314130 0
Ethic Committee of the Faculty of Stomatology, University of Belgrade, Serbia, Europa
Ethics committee address [1] 314130 0
Dr Subotica street, number 8, 11000 Belgrade, Serbia, Europa
Ethics committee country [1] 314130 0
Serbia and Montenegro
Date submitted for ethics approval [1] 314130 0
01/06/2015
Approval date [1] 314130 0
09/07/2015
Ethics approval number [1] 314130 0
36/25

Summary
Brief summary
The purpose of this study is to assess the influence of medication by non-steriod antiinflammatory drugs to elimination of pain in TMJ of selected edentulous patients. This study should have shown that not only construction and design of dentures itself, but parallel aplication of drugs too, could change, reduce or releif a pain in TMJ. Interventions of this study are conducted during clinical situations in the fabrication of the acrylic dentures, as well as after positioning of the dentures in the edentulous mouths in the period of therapy of 9 months. Null hypothesis favor that selected drug application change and releif pain in TMJ of the patients of the experimental group. Hypothesis 1 states that additional drug therapy has no effect to TMJ pain reduction or relief.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 130518 0
A/Prof Srdjan D. Postic
Address 130518 0
Clinic of Dental Prosthetic,Rankeova street number 4, post code 11000 Belgrade, University School of Dental Medicine, University of Belgrade, Beograd, Serbia, Europe
Country 130518 0
Serbia and Montenegro
Phone 130518 0
+381 60 4443466
Fax 130518 0
Email 130518 0
srdjan.postic@stomf.bg.ac.rs
Contact person for public queries
Name 130519 0
A/Prof Srdjan D. Postic
Address 130519 0
Clinic of Dental Prosthetic, University School of Dental Medicine, University of Belgrade, Beograd, Serbia, Europa
Country 130519 0
Serbia and Montenegro
Phone 130519 0
+381 60 4443466
Fax 130519 0
Email 130519 0
sposticdent@yahoo.com
Contact person for scientific queries
Name 130520 0
A/Prof Srdjan D. Postic
Address 130520 0
Clinic of Dental Prosthetic, University School of Dental Medicine, University of Belgrade, Beograd, Serbia, Europa
Country 130520 0
Serbia and Montenegro
Phone 130520 0
+381 60 4443466
Fax 130520 0
Email 130520 0
srdjan.postic@stomf.bg.ac.rs

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.