Partially Edentulous PatientsTRI-RBDNCT07228988
Comparison of Patient Satisfaction Between Conventional and Digital Removable Partial Dentures
A study testing Conventional cast Cr-Co RPDs, 3D Printed Cr-Co RPDS and Milled PEEK RPDs in people with Partially Edentulous Patients, run by King Abdulaziz University at 2 sites in Saudi Arabia.
Trial 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 Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Partially Edentulous Patients
- What is being tested?
- Conventional cast Cr-Co RPDs, 3D Printed Cr-Co RPDS and Milled PEEK RPDs
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 2 sitesSaudi Arabia
- Study dates
- 1 May 2025to 8 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Any systemic diseases that affect oral health, periodontal disease, improper patient compliance, TMD
Trial locations and contacts
2 sites in 1 country.
Saudi Arabia2 sites
Faulty of dentistry King Adbulaziz University-KAU
Jeddah, Western, 23341
King Adbulaziz University-KAU
Jeddah, Westren
About this study
Official title: Patient-Related Outcomes of Digital and Conventional Removable Partial Dentures..A Crossover Randomised Clinical Trial
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
Read the 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
- Being tested
- Conventional cast Cr-Co RPDs, 3D Printed Cr-Co RPDS, Milled PEEK RPDs
- Keywords
- Removable partial denture, Patient satisfaction, Digital partial denture, PEEK, 3D printed printed denture, Oral health quality of life
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional cast Cr-Co RPDsDevice
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 RPDSDevice
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 RPDsDevice
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Device: Milled PEEK RPDs |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
OHIP-14 questionnaire is used to assess the OHRQol
Measured: 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
Single short end question to select one type of denture that was preferred by the patient after using all the three types
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2025
- Study start1 May 2025
- Primary completion30 Nov 2025
- Study completion8 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Partially Edentulous PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Abdulaziz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Enas Mesallum, King Abdulaziz University
- Investigators
- Enas E. Mesallum, PhD, Study director, Assistant Professor of Prosthodontics, King Abdulaziz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07228988
- Sponsor's protocol ID
- 209-12-24 ethical approval
- Acronym
- TRI-RBD
- Status last verified
- Jan 2026
- First submitted
- 13 Nov 2025
- Last updated
- 21 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only summary statistics will be included in the published article later on
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-Related Outcomes of Digital and Conventional Removable Partial Dentures..A Crossover Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT07228988
- Acronym / sponsor ID
- TRI-RBD / 209-12-24 ethical approval
- Conditions
- Partially Edentulous Patients
- Keywords
- Removable partial denture, Patient satisfaction, Digital partial denture, PEEK, 3D printed printed denture, Oral health quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- King Abdulaziz UniversityUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 8 Jan 2026 (actual)
- First posted
- 14 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- 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
| Arm | Type | Receives |
|---|---|---|
| Conventional cast Co-Cr removable partial denture | Active comparator | Device: Conventional cast Cr-Co RPDsThis 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 |
| 3D Printed Cr-Co removable partial denture | Experimental | Device: 3D Printed Cr-Co RPDSThis 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 |
| Milled PEEK removable partial dentures | Experimental | Device: Milled PEEK RPDsThis 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 |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Any systemic diseases that affect oral health, periodontal disease, improper patient compliance, TMD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional 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 | Device | Conventional cast Co-Cr removable partial denture |
| 3D 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 | Device | 3D Printed Cr-Co removable partial denture |
| Milled 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 | Device | Milled PEEK removable partial dentures |
Primary outcome
Patient satisfaction using VAG
Time frame: 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
2 secondary outcomes
Oral Health related Quality of Life OHRQoL
Time frame: 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
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Individual participant dataSharing planned: No. Only summary statistics will be included in the published article later on
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Enas E. Mesallum, PhD study director
Assistant Professor of Prosthodontics, King Abdulaziz University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional cast Cr-Co RPDs, 3D Printed Cr-Co RPDS and Milled PEEK RPDs in people with Partially Edentulous Patients, run by King Abdulaziz University at 2 sites in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient satisfaction using VAG (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.