Partially Edentulous Patients
Conditions
Keywords
Removable partial denture, Patient satisfaction, Digital partial denture, PEEK, 3D printed printed denture, Oral health quality of life
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
Interventions
DEVICEConventional cast Cr-Co RPDs
Conventional Cr-Co RPD is constructed by the standard lost wax technique to act as active comparator being the traditional way of RPD construction
DEVICE3D Printed Cr-Co RPDS
3D Printed Cr-Co was constructed digitally using Laser Melting technology to 3D print the Cr-Co RPD to the same design used with the conventional and the patient used every denture for 30 days with one week wash out
DEVICEMilled PEEK RPDs
PEEK disc was milled using milling machine to construct RPD framework to the same design as other 2 groups, each patient will use all the 3 dentures for one month but with different sequences, after each type one week washout separated between the groups
Sponsors
King Abdulaziz University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
3 intervention arms will be used as participants are randomly assigned to one of the 3 dentures Conventional, 3D printed, or PEEK for one month then after one week washout every patient will switch to another type of dentures for another one month, the final phase after a week of rest each patient will try the third type
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
\- 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
Exclusion criteria
* Any systemic diseases that affect oral health, periodontal disease, improper patient compliance, TMD
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Saudi Arabia
Contacts
STUDY_DIRECTOREnas E. Mesallum, PhD
Assistant Professor of Prosthodontics, King Abdulaziz University
Outcome results
None listed