Clinical Trials Directory

Trials / Completed

CompletedNCT07228988

Comparison of Patient Satisfaction Between Conventional and Digital Removable Partial Dentures

Patient-Related Outcomes of Digital and Conventional Removable Partial Dentures..A Crossover Randomised Clinical Trial

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
36 (actual)
Sponsor
King Abdulaziz University · Academic / Other
Sex
All
Age
20 Years – 70 Years
Healthy volunteers
Not accepted

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

Conditions

Interventions

TypeNameDescription
DEVICEConventional cast Cr-Co RPDsConventional 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 RPDS3D 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 RPDsPEEK 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

Timeline

Start date
2025-05-01
Primary completion
2025-11-30
Completion
2026-01-08
First posted
2025-11-14
Last updated
2026-01-21

Locations

2 sites across 1 country: Saudi Arabia

Source: ClinicalTrials.gov record NCT07228988. Inclusion in this directory is not an endorsement.