Compare CAD/CAM Metallic RPD to Conventional Metallic RPD in Terms of Oral Health Related Quality of Life

NCT06567262 | Not Yet Recruiting DMC

• 1 other identifier: 5724
• Study Type: interventional
• Target: 19
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Partial Edentulism Class 3

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Cost effectiveness

  3 months

Study Arms (2)

CAD/CAM metallic removable partial denture

EXPERIMENTAL

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.

Device: CAD/CAM metallic removable partial denture

Conventional metallic removable partial denture

ACTIVE COMPARATOR

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.

Device: Conventional metallic removable partial denture

Interventions

CAD/CAM metallic removable partial denture DEVICE

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.

CAD/CAM metallic removable partial denture

Conventional metallic removable partial denture DEVICE

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.

Conventional metallic removable partial denture

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Central Study Contacts

tarek salah ali, assistant lecturer

CONTACT

01061608893; tarek.salah@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer

Study Record Dates

• First Submitted: August 20, 2024
• First Posted: August 22, 2024
• Study Start: October 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: March 1, 2025
• Last Updated: August 26, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share