About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Patients with unilateral bounded saddles in the mandible (Kennedy class III).
Opposing dentition is fully intact or restored.
Sufficient inter-arch space.
Angle's class I maxilla-mandibular relationship.
Disqualifiers
Periodontal affection of the abutment teeth.
Skeletal mal-relation.
Unmotivated patients to maintain adequate oral hygiene to follow up.
Patients with neuromuscular and Psychiatric disorders.
Trial design
Crossover
Treatments tested in this trial
CAD/CAM metallic removable partial denture
DeviceMake 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.
Conventional metallic removable partial denture
DevicePrimary 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.
Treatment groups
Trial outcomes
Primary outcomes
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).
Secondary outcomes
Cost effectiveness
Cost effectiveness analysis - The incremental cost-effectiveness ratio (ICER) will be calculated using the following formula: ICER = direct cost difference / outcome score difference between CAD/CAM metallic RPD and Conventional metallic RPD \- ICER indicates an additional cost that needs to increase extra one unit in each outcome measure with CAD/CAM metallic RPD comparing to Conventional metallic RPD treatment
Locations
Sponsors and contacts
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