Comparison of Patient Satisfaction Between Conventional and Digital Removable Partial Dentures
- Conditions
- Partially Edentulous Patients
- Registration Number
- NCT07228988
- Lead Sponsor
- King Abdulaziz University
- Brief Summary
Study type: cross over within subject clinical trial Primary aim: To compare patient satisfaction among three different RPDs: conventional cast Co-Cr, 3D-printed Co-Cr, and PEEK RPDs.
Secondary aim: To evaluate the impact of these RPDs on oral health-related quality of life and patient preference among these RPDs
- Detailed Description
A within-subject randomized crossover clinical was conducted at the Faculty of Dentistry, King Abdulaziz University after obtaining an ethical approvalfrom the Faculty Ethical Committee. All patients have signed a consent before being enrolled in the study.
Each participant received three RPDs using three manufacturing techniques (conventional cast Co-Cr, 3D-printed Co-Cr, and milled PEEK) fabricated to the same RPD design specifications. Each RPD worn for 30 days with a one-week washout period between the trial phases.
Participants were selected from partially edentulous patients fulfilling mandibular Kennedy Class I with the first or second premolars as the last abutment teeth bilaterally . Inclusion criteria include good oral hygiene, healthy mucosa, and absence of systemic diseases affecting oral tissues. Exclusion criteria include allergy to materials, poor compliance, or history of temporomandibular disorders.
Sample size estimation is based on detecting a moderate effect size (f = 0.25) with 80% power and α = 0.05, requiring at least 30 participants. To account for possible dropouts, a total of 36 patients was recruited.
Patient satisfaction was assessed using the Visual Analogue Grade (VAG) scale (0-100 mm). The VAG evaluates satisfaction domains such as comfort, esthetics, speech, and mastication, while OHIP-14 measures the impact of oral health on quality of life through 14 questions covering 7 domains. At the end of all the treatment phases participants determined the most preferred denture by answering single choice question of the best overall denture among the three types.
Results will be statistically analysed using one ANOVA test and Tukeys test if the difference between groups is significant
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 36
- Partially edentulous patients with mandibular Kennedy class I, last abutment is the first or second premolars, maxillary arch is dentate or restored, good oral hygiene
- Any systemic diseases that affect oral health, periodontal disease, improper patient compliance, TMD
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Patient satisfaction using VAG Delivery of the first denture type 1st questionnaire 30 days after receiving the first denture 7 days wash out Delivery of the second denture type 2nd questionnaire 30 days after using the denture 7 days wash out Final questionnaire after 30 days Visual Analogue Grade 100 mm scale is used to measure patient satisfaction and comfort as zero indicates the worst and 100 indicates the best response
- Secondary Outcome Measures
Name Time Method Oral Health related Quality of Life OHRQoL Delivery of the first denture type 1st questionnaire 30 days after receiving the first denture 7 days wash out Delivery of the second denture type 2nd questionnaire 30 days after using the denture 7 days wash out Final questionnaire after 30 days OHIP-14 questionnaire is used to assess the OHRQol
Patient preference After all the three dentures treatment phase 30 days after the delivery of the last denture according to sequence randomisation Study time line was 6 months from recruitment to final questionnaire Single short end question to select one type of denture that was preferred by the patient after using all the three types
Trial Locations
- Locations (2)
Faulty of dentistry King Adbulaziz University-KAU
🇸🇦Jeddah, Western, Saudi Arabia
King Adbulaziz University-KAU
🇸🇦Jeddah, Westren, Saudi Arabia
Faulty of dentistry King Adbulaziz University-KAU🇸🇦Jeddah, Western, Saudi Arabia