Partial Edentulism Class 3NCT07863427
Clinical Fit of Conventionally Cast and 0° SLM Removable Partial Denture Frameworks
A study testing Conventionally Cast Cobalt-Chromium RPD Framework and 0° Selective Laser-Melted Cobalt-Chromium RPD Framework in people with Partial Edentulism Class 3 and Removable Partial Denture, run by IBB University at 1 site in Yemen.
Trial summary
This exploratory pilot clinical study evaluates the fit accuracy of cobalt-chromium removable partial denture (RPD) frameworks fabricated using conventional lost-wax casting and selective laser melting (SLM) at a 0° build orientation. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Partial Edentulism Class 3, Removable Partial Denture
- What is being tested?
- Conventionally Cast Cobalt-Chromium RPD Framework and 0° Selective Laser-Melted Cobalt-Chromium RPD Framework
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteYemen
- Study dates
- 15 Sep 2025to 30 Nov 2026
- Phase
- Interventional
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 years. Maxillary and mandibular Kennedy Class III modification 1 partially edentulous arches, with each arch containing both short and long edentulous spans.
- Moderate or shallow maxillary palatal vault. Basic Periodontal Examination (BPE) score of 0-1, corresponding to probing depths ≤3.5 mm.
- Absence of major systemic health conditions that could preclude dental treatment.
- -
Who cannot join
- Bone or soft-tissue defects affecting the partially edentulous arches. Alcohol abuse. Clinical findings considered by the investigator to render participation inappropriate.
- Mental disability or inability to adequately care for the prosthesis.
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fit Accuracy of Maxillary and Mandibular Removable Partial Denture Frameworks Fabricated by Conventional Casting and Selective Laser Melting at a 0° Build Orientation: A Clinical Silicone-Replica Comparison
This exploratory pilot clinical study evaluates the fit accuracy of cobalt-chromium removable partial denture (RPD) frameworks fabricated using conventional lost-wax casting and selective laser melting (SLM) at a 0° build orientation. Two partially edentulous participants with maxillary and mandibular Kennedy Class III modification 1 arches are included. Each participant receives four RPD frameworks: one conventionally cast and one 0° SLM framework for the maxillary arch, and one conventionally cast and one 0° SLM framework for the mandibular arch. Framework adaptation is evaluated using the silicone-replica technique and microscopic measurement of the gap between the framework and supporting oral structures at predefined locations. The study primarily compares framework fit between the two fabrication techniques and also explores differences between short- and long-edentulous-span sides and between maxillary and mandibular frameworks.
Read the detailed description
This exploratory pilot clinical study includes two partially edentulous participants, each presenting with maxillary and mandibular Kennedy Class III modification 1 arches containing both short and long edentulous spans. For each participant and each arch, one cobalt-chromium RPD framework is fabricated using the conventional lost-wax casting technique and one using selective laser melting (SLM) at a 0° build orientation. A total of eight frameworks are evaluated: four maxillary and four mandibular frameworks, comprising four conventionally cast and four SLM frameworks.
Framework fit is assessed clinically using the silicone-replica technique. Light-body silicone is applied to the fitting surfaces of the major connector, proximal plates, denture-base minor connectors, occlusal rests, and clasp arms. Each framework is seated intraorally under standardized finger pressure until polymerization. The resulting silicone film representing the framework-to-tissue gap is stabilized with heavy-body silicone, sectioned at predefined locations, and examined microscopically at ×40 magnification. Three readings are obtained at each measurement location, and their mean is recorded as the gap distance in micrometers.
Each maxillary framework contributes 40 predefined measurement locations, whereas each mandibular framework contributes 32 locations. The primary comparison evaluates gap distances between conventionally cast and 0° SLM frameworks under matched participant, arch, component, and measurement-location conditions. Secondary exploratory comparisons assess differences between short- and long-edentulous-span sides and between maxillary and mandibular frameworks.
- Being tested
- Conventionally Cast Cobalt-Chromium RPD Framework, 0° Selective Laser-Melted Cobalt-Chromium RPD Framework
- Keywords
- RPD Framework; Selective Laser Melting; SLM; Conventional Casting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventionally Cast Cobalt-Chromium RPD FrameworkDevice
Cobalt-chromium removable partial denture framework fabricated using the conventional lost-wax casting technique. The framework is clinically seated, and its adaptation is evaluated using silicone-replica microscopic measurement at predefined framework locations.
0° Selective Laser-Melted Cobalt-Chromium RPD FrameworkDevice
Cobalt-chromium removable partial denture framework digitally designed and fabricated by selective laser melting at a 0° build orientation. The framework is clinically seated, and its adaptation is evaluated using silicone-replica microscopic measurement at predefined framework locations.
| Study group | Role | What they receive |
|---|---|---|
| Within-Participant RPD Framework Comparison | Experimental | Each participant receives both conventionally cast and 0° selective laser-melted cobalt-chromium removable partial denture frameworks for the maxillary and mandibular arches. For each arch, one framework is fabricated using the conventional lost-wax casting technique and one using selective laser melting at a 0° build orientation. Framework adaptation is assessed intraorally using the silicone-replica technique. Receives: Device: Conventionally Cast Cobalt-Chromium RPD Framework; Device: 0° Selective Laser-Melted Cobalt-Chromium RPD Framework |
What is being measured
The primary outcome is the main question the study is designed to answer.
Framework-to-Tissue Gap Distance by Fabrication Technique
Gap distance, expressed in micrometers (µm), between the fitting surface of each removable partial denture framework and the corresponding intraoral supporting structures, measured using the silicone-replica technique at predefined framework locations. Three microscopic readings are obtained at each location, and their mean is used as the gap value. Gap distances are compared descriptively between conventionally cast and 0° selective laser-melted frameworks under matched participant, arch, framework-component, and measurement-location conditions.
Measured: Immediately after clinical seating and adjustment of each framework, during the framework assessment visit.
Secondary outcomes (2)
Framework-to-Tissue Gap Distance by Edentulous-Span Length
Gap distance, expressed in micrometers (µm), is compared descriptively between corresponding framework components located on the short- and long-edentulous-span sides within each fabrication technique and dental arch.
Measured: Immediately after clinical seating and adjustment of each framework, during the framework assessment visit.
Framework-to-Tissue Gap Distance by Dental Arch
Gap distance, expressed in micrometers (µm), is compared descriptively between maxillary and mandibular removable partial denture frameworks under matched participant, fabrication-technique, and framework-component conditions. Major-connector findings are interpreted separately because the maxillary and mandibular major connectors differ in design and number of measurement locations.
Measured: Immediately after clinical seating and adjustment of each framework, during the framework assessment visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2026
- Study start15 Sep 2025
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Partial Edentulism Class 3Studies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- IBB University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, radwan saleh algabri, IBB University
- Investigators
- Radhwan Al-Gabri, PhD, Principal investigator, IBB University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07863427
- Sponsor's protocol ID
- RPD-SLM-2025-01
- Status last verified
- Oct 2026
- First submitted
- 2 Oct 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual participant data underlying the results reported in the published article will be available from the corresponding author upon reasonable request, subject to appropriate ethical and institutional considerations.
Publications
Gan N, Yao M, Ruan Y, Wang C, Xiong Y, Jiao T. Adaptation of maxillary removable partial denture frameworks fabricated with a direct digital workflow: A randomized crossover clinical trial. J Dent. 2025 Mar;154:105588. doi: 10.1016/j.jdent.2025.105588. Epub 2025 Jan 27.
PubMed 39864610Ye H, Ning J, Li M, Niu L, Yang J, Sun Y, Zhou Y. Preliminary Clinical Application of Removable Partial Denture Frameworks Fabricated Using Computer-Aided Design and Rapid Prototyping Techniques. Int J Prosthodont. 2017 Jul/Aug;30(4):348-353. doi: 10.11607/ijp.5270.
PubMed 28697204Chia VAP, See Toh YL, Quek HC, Pokharkar Y, Yap AU, Yu N. Comparative clinical evaluation of removable partial denture frameworks fabricated traditionally or with selective laser melting: A randomized controlled trial. J Prosthet Dent. 2024 Jan;131(1):42-49. doi: 10.1016/j.prosdent.2021.12.021. Epub 2022 Mar 5.
PubMed 35260255Elhadery SS, Alhajj MN, Yunus N, Ibrahim N, Abidin ZZ, Ahmad SF, Salleh NM. Adaptation of cobalt chromium frameworks fabricated by conventional versus selective laser melting techniques: An in vitro and clinical assessment. J Prosthet Dent. 2025 Nov;134(5):1836-1842. doi: 10.1016/j.prosdent.2024.03.020. Epub 2024 Apr 15.
PubMed 38627176