Oral Health Related Quality of Life and Cost Effectiveness in CAD/CAM and Conventional Metallic Partial Denture Frameworks in Mandibular Kennedy Class III Cases: A Randomised Cross-over Trial
Sponsor study identifier
interventional
19
0 countries
N/A
Study Start
October 2024
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Primary Completion
December 2024
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Study Completion
March 2025
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Patients will be randomised to receive CAD/CAM metallic removable partial denture (RPD) followed by Conventional metallic RPD (Group A), or the opposite sequence (Group B), with a 3-month wear duration for each denture and washout period for one week. Patients will be recalled at base line and 3 months following prosthetic insertion to evaluate Oral health related quality of life. It is hypothesized that removable partial dentures with CAD/CAM metallic RPD frameworks would improve Oral health related quality of life than those with Conventional metallic RPD frameworks.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2025
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August 20, 2024
Actual (reported)August 22, 2024
Actual (reported)October 2024
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December 2024
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March 2025
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Oral health related quality of life
Oral health related quality of life will be measured by a valid and reliable questionnaire which is Oral health impact profile questionnaire (OHIP) before RPD insertion then after RPD insertion with one and 3 months for both groups. It consists of 5 questions representing the four suggested dimensions: Oral Function, Orofacial Pain, Orofacial Appearance and Psychosocial Impact. Questions were made on a 5-point Likert scale (0 = never; 1 = hardly ever; 2 = occasionally; 3 = fairly often; and 4 = very often).
3 months
Cost effectiveness
3 months
CAD/CAM technology will be used to scan the oral cavity to create a 3D model that can be digitally surveyed. After designing RPD digitally by computer software, wax pattern can be constructed by milling or rapid prototyping technology. This wax pattern would be cast conventionally into RPD framework.
Conventional RPD design involves the production of stone casts, geometric characterization of the tooth and soft tissues related to the path of insertion, and careful designation of RPD components (major and minor connectors, rests, clasps, and base retention) using a direct waxing method.
Make digital scans using an intraoral scanning device. Scan the maxillary (antagonistic scan) and mandibular (pre-preparation scan) arches, as well as an initial digital record of the inter-occlusal relation (occlusal scan). Analyse the digital cast using CAD software. Primary electronic surveying will be carried out to ensure if the tooth preparations will be needed. Make a definitive intraoral scan only of the prepared teeth and record the maxillary-mandibular relationship. The virtual cast is digitally surveyed and the design of the framework is done using computer software. The wax pattern 3D framework information will be converted into a standard tessellation language (STL) file and transfer to a rapid prototyping (RP) system to be printed and finally cast using the conventional technique to produce RPD framework.
First Submitted
August 20, 2024
First Posted
August 22, 2024
Study Start
October 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
Primary impressions will be taken, the impressions will be poured to construct a study casts. Maxillary Face-bow record and diagnostic bite will be taken. The study casts will be mounted on semi adjustable articulator to check inter-arch space. Surveying of the study cast will be done. Required mouth preparation will be carried out then secondary impression will be taken using special tray. Secondary impression will be poured to obtain master cast which will be surveyed to confirm proper mouth preparation, blocked out and then wax pattern will be designed and constructed. A metallic framework will be obtained using the conventional lost wax technique and casting. Intraoral try in of the framework will be done followed by bite registration record. The next step will be teeth setting and try in. Heat cured acrylic resin denture base will be processed, finished and polished conventionally.
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December 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 2025
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Last Updated
August 26, 2024
Record last verified: 2024-08
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