An interventional study of Conventionally Cast Cobalt-Chromium RPD Framework and 0° Selective Laser-Melted Cobalt-Chromium RPD Framework in Partial Edentulism Class 3 and Removable Partial Denture, sponsored by IBB University. Active, not recruiting at 1 site in Yemen. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-10-07.
Sponsored by IBB University · Not applicable, Interventional, and Other
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.
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.
IBB University is the lead sponsor of 3 studies on the registry; none are open to participants now.
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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.
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Exclusion Criteria:
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.
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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.
Device: Conventionally Cast Cobalt-Chromium RPD Framework · Device: 0° Selective Laser-Melted Cobalt-Chromium RPD Framework
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.
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.
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.
Time frame: Immediately after clinical seating and adjustment of each framework, during the framework assessment visit.
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.
Time frame: 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.
Time frame: Immediately after clinical seating and adjustment of each framework, during the framework assessment visit.
Plan to share: 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.
Supporting information: Study protocol
Time frame: Beginning 6 months after publication and available for 5 years.
Access criteria: Data will be available to qualified researchers who submit a reasonable request for scientific purposes. Requests will be reviewed by the study investigators, and data will be shared only after appropriate ethical and confidentiality requirements are satisfied.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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