Comparison of Patient Satisfaction Between Conventional and Digital Removable Partial Dentures (TRI-RBD)

King Abdulaziz University

Status: Completed

Conditions: Partially Edentulous Patients

Treatments: Device: 3D Printed Cr-Co RPDS; Device: Conventional cast Cr-Co RPDs; Device: Milled PEEK RPDs

Study type: Interventional

Funder types: Other

Identifiers

NCT07228988

209-12-24 ethical approval

Details and patient eligibility

About

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

Full 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

Enrollment: 36 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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36 participants in 3 patient groups

Conventional cast Co-Cr removable partial denture

Active Comparator group

Description:

This type of RPD is constructed from Cobalt Chromium metal framework using the lost wax technique conventional casting of a wax pattern made on an investment cast.. Each participant used the conventional denture for 30 days then they received the VAS and OHIP-14 questionnaire about their denture experience..Then wait one week without any dentures until they received the second denture type

Treatment:

Device: Conventional cast Cr-Co RPDs

3D Printed Cr-Co removable partial denture

Experimental group

Description:

This is a digital RPD made from Cobalt Chromium metal which is printed by a 3D printer using selective laser melting technique..Each participant used the 3D printed denture for 30 days then they received the VAS and OHIP-14 questionnaire about their denture experience..Then wait one week without any dentures until they received the next denture type

Treatment:

Device: 3D Printed Cr-Co RPDS

Milled PEEK removable partial dentures

Experimental group

Description:

This is a digital type of RPD made by milling polyetheretherktone discs using a milling machine..Each participant used the PEEK denture for 30 days then they received the VAS and OHIP-14 questionnaire about their denture experience..Then wait one week without any dentures until they received the other denture type

Treatment:

Device: Milled PEEK RPDs