Periodontal Health and Patient Satisfaction of CAD/CAM Fiber-Reinforced vs. PFM Attachments in Distal Extension RPDs

NCT ID: NCT06871020

Last Updated: 2025-09-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-01
• Study Completion Date: 2025-09-15

Brief Summary

This randomized clinical trial aims to assess periodontal health and patient satisfaction in mandibular distal extension removable partial dentures using CAD/CAM fiber-reinforced composite versus porcelain-fused-to-metal extracoronal attachments. Twelve participants with bilateral mandibular Kennedy Class I, retaining only the first premolars as the last standing abutments, will be randomly assigned to two groups. Group I will receive OT extracoronal attachments made from CAD/CAM fiber-reinforced composite, while Group II will receive OT extracoronal attachments made from porcelain-fused-to-metal. All participants will then receive a metallic removable partial denture. The null hypothesis states that no significant differences will be observed in periodontal health and patient satisfaction between the two attachment types.

Detailed Description

Twelve participants with bilateral maxillary Kennedy Class I, with the first premolars as the last standing abutments, will be recruited based on strict inclusion criteria from the oral and maxillofacial prosthodontic outpatient clinic. The canines and first premolars will be prepared to receive OT extracoronal attachments made from either CAD/CAM fiber-reinforced composite (Group I) or porcelain-fused-to-metal (Group II), according to group allocation. All participants will then receive a metallic removable partial denture. Periodontal health will be assessed through bleeding index, probing depth, and gingival recession at denture insertion and after six months. Patient satisfaction will also be evaluated at the six-month follow-up.

Conditions

Mandibular Distal-extension Prostheses

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

OT Extracoronal attachment made from CAD-CAM fiber-reinforced composite resin.

The patient will receive a removable partial denture retained by bilateral OT extracoronal attachments made from CAD/CAM fiber-reinforced composite resin. These attachments will be fabricated on the prepared first premolars and canines on each side.

Group Type: EXPERIMENTAL

Mandibular removable partial denture retained on OT extracoronal attachment made from fiber-reinforced composite resin

Intervention Type: OTHER

Bilateral OT extracoronal attachments will be milled from fiber-reinforced composite resin after obtaining impressions of the prepared abutments. This will be followed by an overall impression of fabricating a Co-Cr removable partial denture to be retained in the attachments.

OT Extracoronal attachment made from porcelain-fused-to-metal

The patient will receive a removable partial denture retained by bilateral T Extracoronal attachment made from porcelain-fused-to-metal . These attachments will be fabricated on the prepared first premolars and canines on each side.

Group Type: ACTIVE_COMPARATOR

Mandibular removable partial denture retained on OT extracoronal attachment made from porcelain-fused to metal

Intervention Type: OTHER

Bilateral OT attachments manufactured from porcelain fused to metal by conventional technique after obtaining impressions of the prepared abutments. This will be followed by an overall impression of fabricating a Co-Cr removable partial denture to be retained in the attachments.

Interventions

Mandibular removable partial denture retained on OT extracoronal attachment made from fiber-reinforced composite resin

Bilateral OT extracoronal attachments will be milled from fiber-reinforced composite resin after obtaining impressions of the prepared abutments. This will be followed by an overall impression of fabricating a Co-Cr removable partial denture to be retained in the attachments.

Intervention Type: OTHER

Mandibular removable partial denture retained on OT extracoronal attachment made from porcelain-fused to metal

Bilateral OT attachments manufactured from porcelain fused to metal by conventional technique after obtaining impressions of the prepared abutments. This will be followed by an overall impression of fabricating a Co-Cr removable partial denture to be retained in the attachments.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Mandibular partially edentulous bilateral distal extension Kennedy Class I with first premolars as last abutments.

2. The opposing maxillary arch will be dentate.

3. Angle class I maxillomandibular skeletal relation.

4. The distal extension ridge will be well-formed and covered by healthy and firm mucosa.

5. As verified by periapical radiographs, Abutments have healthy periodontal ligaments and an appropriate crown/root ratio (CRR).

6. Crown/root ratio of the premolar abutment teeth is not less than 1:1. 5.

7. The vertical distance between the ridge tissue and the opposing teeth of the study cases is not less than 7 mm. 6.

8. The buccolingual dimension of the abutment teeth is not less than 6 mm.

Exclusion Criteria

1. Patients with any systemic disease that could affect the rate of bone resorption, which was confirmed by obtaining a through medical history.

2. Patients with parafunctional habits (bruxism and clenching).

3. Patients with any septic foci or impacted teeth as proved by panoramic radiograph, as well as patients with tilted or rotated abutments or soft tissue undercuts in areas that will be involved in the RDP design.

4. Patients with any TMJ problems.

5. Patients with any neuromuscular diseases.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Omnia M. Refai

Lecturer of Oral and Maxillofacial Prosthodontics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Omnia M. Refai, PHD

Role: PRINCIPAL_INVESTIGATOR

Ain Shams Univeristy

Noha Helmy Hassan Nawar, PHD

Role: STUDY_DIRECTOR

Ain Shams Univeristy

Heba A. Salama, PHD

Role: PRINCIPAL_INVESTIGATOR

Misr International University

Abdel Rahman Maged, PHD

Role: PRINCIPAL_INVESTIGATOR

Misr International University

Locations

Faculty of Dentistry Ain Shams University

Cairo, , Egypt

Countries

Egypt

Other Identifiers

FDASU-RecIR122439

Identifier Type: -

Identifier Source: org_study_id