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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Cairo University
- Enrollment
- 19
- Primary Endpoint
- Oral health related quality of life
Study Overview
Brief Summary
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.
Detailed Description
Eligible patient will be selected from outpatient clinic in removable prosthodontics department clinic. Patients will be informed of the nature of the research work and informed consent will be obtained from each of them. Only motivated patients who shows cooperation will participate in the study. Patients will be randomised to receive CAD/CAM metallic 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 and cost effectiveness.
Patients will be subjected to:
- Comprehensive clinical examination and understanding of patient's chief complaints and their expectations from the prosthesis.
- Digital periapical radiographs with paralleling technique will be taken for the abutment teeth as base line for bone height before prosthesis construction.
CAD/CAM metallic RPD:
- 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.
- The overall treatments costs, including the fees from the dental laboratory, will be calculated and compared with the costs of a conventionally fabricated RPD.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
- •Systematic disease affecting bone and periodontal health.
- •Insufficient inter-arch space.
- •Patients with physical reasons that could affect follow up.
Arms & Interventions
CAD/CAM metallic removable partial denture
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.
Intervention: CAD/CAM metallic removable partial denture (Device)
Conventional metallic removable partial denture
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.
Intervention: Conventional metallic removable partial denture (Device)
Outcomes
Primary Outcomes
Oral health related quality of life
Time Frame: 3 months
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(3 months)
Investigators
Tarek Salah Hashim Ali
assistant lecturer
Cairo University