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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.

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12624000434594
Enrollment
90
Registered
2024-04-09
Start date
2015-10-15
Completion date
2023-09-04
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

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 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 dentu

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..

Sponsors

Srdjan D. Postic
Lead SponsorIndividual

Study design

Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
41 Years to 67 Years
Healthy volunteers
No

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.

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026