Complete Edentulism Clinical Trial
Official title:
Simplified Versus Conventional Complete Dentures: A Randomized Crossover Clinical Trial
Verified date | September 2021 |
Source | University of Jordan |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this randomized, double-blind, 2-period crossover trial was to assess the satisfaction of edentulous patients and their oral health impact profile when provided with complete dentures fabricated using the conventional and simplified techniques.
Status | Completed |
Enrollment | 40 |
Est. completion date | May 31, 2021 |
Est. primary completion date | May 31, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 40 Years to 85 Years |
Eligibility | Inclusion Criteria: Inclusion Criteria 1. Patients seeking new conventional complete dentures for first time or as replacement of their previous complete dentures 2. Patients aged 40-85 y. 3. Patients who had been completely edentulous for at least 6 months 4. Patients who had well developed to moderately resorbed maxillary and mandibular ridges 5. Patients who had no denture fissuratum or any traumas from previous dentures 6. Patients who had no relevant medical issues, disorders of the masticatory system, neuromuscular dysfunction, auditory problems, psychological or psychiatric conditions that can affect the response to treatment, oral pathology, xerostomia, or tied tongue condition. 7. Patients had medical and dental insurance to cover the fees for construction of dentures by a Prosthodontic specialist 8. Patients who signed consent form - Exclusion Criteria: - |
Country | Name | City | State |
---|---|---|---|
Jordan | The University of Jordan | Amman |
Lead Sponsor | Collaborator |
---|---|
University of Jordan |
Jordan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Patient satisfaction questionnaire | Visual analogue scale (0-10) for a 10 item questionnaire regarding patient satisfaction with the dentures | 1 month after denture delivery | |
Primary | OHIP-EDENT | 20-item oral health impact profile for edentulous patients questionnaire | I month after denture delivery |
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