NCT07228988

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2025

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 13, 2025

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 14, 2025

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 8, 2026

Completed
Last Updated

January 21, 2026

Status Verified

January 1, 2026

Enrollment Period

7 months

First QC Date

November 13, 2025

Last Update Submit

January 16, 2026

Conditions

Keywords

Removable partial denturePatient satisfactionDigital partial denturePEEK3D printed printed dentureOral health quality of life

Outcome Measures

Primary Outcomes (1)

  • Patient satisfaction using VAG

    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

    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

Secondary Outcomes (2)

  • 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

  • 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

Study Arms (3)

Conventional cast Co-Cr removable partial denture

ACTIVE COMPARATOR

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

Device: Conventional cast Cr-Co RPDs

3D Printed Cr-Co removable partial denture

EXPERIMENTAL

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

Device: 3D Printed Cr-Co RPDS

Milled PEEK removable partial dentures

EXPERIMENTAL

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

Device: Milled PEEK RPDs

Interventions

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

Conventional cast Co-Cr removable partial denture

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

3D Printed Cr-Co removable partial denture

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

Milled PEEK removable partial dentures

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- 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

You may not qualify if:

  • Any systemic diseases that affect oral health, periodontal disease, improper patient compliance, TMD

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Faulty of dentistry King Adbulaziz University-KAU

Jeddah, Western, 23341, Saudi Arabia

Location

King Adbulaziz University-KAU

Jeddah, Westren, Saudi Arabia

Location

MeSH Terms

Conditions

Patient Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Enas E. Mesallum, PhD

    Assistant Professor of Prosthodontics, King Abdulaziz University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 13, 2025

First Posted

November 14, 2025

Study Start

May 1, 2025

Primary Completion

November 30, 2025

Study Completion

January 8, 2026

Last Updated

January 21, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Only summary statistics will be included in the published article later on

Locations