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Completed

NCT Number: NCT06871020

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

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.

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Key information

Conditions

Mandibular Distal-extension Prostheses

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry Ain Shams University

Cairo, 12345, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Mandibular partially edentulous bilateral distal extension Kennedy Class I with first premolars as last abutments.
  • The opposing maxillary arch will be dentate.
  • Angle class I maxillomandibular skeletal relation.
  • The distal extension ridge will be well-formed and covered by healthy and firm mucosa.
  • As verified by periapical radiographs, Abutments have healthy periodontal ligaments and an appropriate crown/root ratio (CRR).
  • Crown/root ratio of the premolar abutment teeth is not less than 1:1. 5.
  • The vertical distance between the ridge tissue and the opposing teeth of the study cases is not less than 7 mm. 6.
  • The buccolingual dimension of the abutment teeth is not less than 6 mm.

Exclusion criteria

  • Patients with any systemic disease that could affect the rate of bone resorption, which was confirmed by obtaining a through medical history.
  • Patients with parafunctional habits (bruxism and clenching).
  • 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.
  • Patients with any TMJ problems.
  • Patients with any neuromuscular diseases.

Treatment and study plan

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

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.

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

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.

Primary outcomes

  1. Evaluation of Bleeding index

    Time frame: At denture insertion ( baseline 0) and six months (180 days) after delivery of mandibular removable partial denture retained on double OT Extracoronal attachments

    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).

  2. Evaluation of Probing Pocket Depth (PPD)

    Time frame: 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 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.

  3. Evaluation Gingival Index (GI)

    Time frame: 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 of Gingival index: Evaluated using Löe and Silness (1963), scoring gingival inflammation from 0 (healthy) to 3 (severe inflammation with spontaneous bleeding).

Secondary outcomes

  1. Evaluation of Patient Satisfaction

    Time frame: After tweleve months (180 days) after delivery of mandibular removable partial denture retained on double OT Extracoronal attachments

    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.

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 11, 2025
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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