Comparison of Patient Satisfaction Between Conventional and Digital Removable Partial Dentures

NCT ID: NCT07228988

Last Updated: 2026-01-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-01
• Study Completion Date: 2026-01-08

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

Conditions

Partially Edentulous Patients

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Conventional cast Co-Cr removable partial denture

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

Group Type: ACTIVE_COMPARATOR

Conventional cast Cr-Co RPDs

Intervention Type: DEVICE

Conventional Cr-Co RPD is constructed by the standard lost wax technique to act as active comparator being the traditional way of RPD construction

3D Printed Cr-Co removable partial denture

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

Group Type: EXPERIMENTAL

3D Printed Cr-Co RPDS

Intervention Type: DEVICE

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

Milled PEEK removable partial dentures

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

Group Type: EXPERIMENTAL

Milled PEEK RPDs

Intervention Type: DEVICE

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

Interventions

Conventional 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

Intervention Type: DEVICE

3D 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

Intervention Type: DEVICE

Milled 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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

King Abdulaziz University

OTHER

Sponsor Role: lead

Responsible Party

Enas Mesallum

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Enas E. Mesallum, PhD

Role: STUDY_DIRECTOR

Assistant Professor of Prosthodontics, King Abdulaziz University

Locations

Faulty of dentistry King Adbulaziz University-KAU

Jeddah, Western, Saudi Arabia

King Adbulaziz University-KAU

Jeddah, Westren, Saudi Arabia

Countries

Saudi Arabia

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

209-12-24 ethical approval

Identifier Type: -

Identifier Source: org_study_id