ActivePhase 2Phase 3ACTRN12624000434594

Efficacy of anti-inflammatory drugs in jaw-joint pain in edentulous patients.

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.


Sponsor

Srdjan D. Postic

Enrollment

90 participants

Start Date

Oct 15, 2015

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 41 YearssMax Age: 67 Yearss

Inclusion Criteria1

  • 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.

Exclusion Criteria9

  • 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.

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Interventions

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

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..


Locations(1)

Serbia, Serbia and Montenegro

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ACTRN12624000434594