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

Evaluation of Periodontal Health and Patient Satisfaction of CAD/CAM Fiber-Reinforced Composite Versus Porcelain Fused to Metal Extracoronal Attachment in Mandibular Distal Extension Removable Partial Dentures: A Randomized Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Mandibular Distal-extension Prostheses
• Intervention / Treatment: Other: Mandibular removable partial denture retained on OT extracoronal attachment made from fiber-reinforced composite resin; Other: Mandibular removable partial denture retained on OT extracoronal attachment made from porcelain-fused to metal

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 and twelve months. Patient satisfaction will also be evaluated at the twelve-month follow-up.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 12345
    • Faculty Of Dentistry Ain Shams University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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.
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of Bleeding index	The bleeding Index will be evaluated at denture insertion and after six months (180 days: Assessed using Mombelli's Bleeding Index, which scores bleeding on probing (BOP) from 0 (no bleeding) to 3 (heavy bleeding).	At denture insertion ( baseline 0) and six months (180 days) after delivery of mandibular removable partial denture retained on double OT Extracoronal attachments
Evaluation of Probing Pocket Depth (PPD)	Evaluation of Probing Pocket Depth (PPD)will be evaluated at denture insertion and after six months: Measured on buccal and lingual aspects of the four abutments following the American Academy of Periodontology protocol. Six readings per abutment will be averaged.	At denture insertion ( baseline 0), six months (T1) , and 12 months (T2) after delivery of mandibular removable partial denture retained on double OT Extracoronal attachments
Evaluation Gingival Index (GI)	Evaluation of Gingival index: Evaluated using Löe and Silness (1963), scoring gingival inflammation from 0 (healthy) to 3 (severe inflammation with spontaneous bleeding).	At denture insertion ( baseline 0), six months (T1) , and 12 months (T2) after delivery of mandibular removable partial denture retained on double OT Extracoronal attachments

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of Patient Satisfaction	Patient satisfaction will be evaluated using the McGill Denture Satisfaction Questionnaire and a visual analog scale (VAS). Satisfaction will be measured across multiple aspects, including ease of cleaning, speech ability, comfort, esthetics, stability, mastication of various foods, masticatory efficiency, oral condition, and overall satisfaction. Patients will rate each item on a 0-100 scale, where 0 represents complete dissatisfaction and 100 indicates total satisfaction.	After tweleve months (180 days) after delivery of mandibular removable partial denture retained on double OT Extracoronal attachments

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Principal Investigator: Omnia M. Refai, PHD, Ain Shams Univeristy; Study Director: Noha Helmy Hassan Nawar, PHD, Ain Shams Univeristy; Principal Investigator: Heba A. Salama, PHD, Misr International University; Principal Investigator: Abdel Rahman Maged, PHD, Misr International University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2025
• Primary Completion (Actual): January 1, 2026
• Study Completion (Actual): March 15, 2026

Study Registration Dates

• First Submitted: February 22, 2025
• First Submitted That Met QC Criteria: March 5, 2025
• First Posted (Actual): March 11, 2025

Study Record Updates

• Last Update Posted (Actual): July 8, 2026
• Last Update Submitted That Met QC Criteria: July 5, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: CAD/CAM; Fiber Reinforced Composite; Denture Precision Attachment; Denture, Partial, Removable
• Other Study ID Numbers: FDASU-RecIR122439

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No