Comparing two types of attachments for removable dentures
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 study is testing whether two different types of attachments for removable dentures can improve gum health and how happy patients are with their dentures.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | Ain Shams University Academic / other |
| Locations | 1 site (Cairo) |
| Trial ID | NCT06871020 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the periodontal health and patient satisfaction of mandibular distal extension removable partial dentures using two different attachment types: CAD/CAM fiber-reinforced composite and porcelain-fused-to-metal. Twelve participants with specific dental conditions will be randomly assigned to receive one of the two attachment types, followed by the placement of a metallic removable partial denture. Periodontal health will be assessed through various clinical measures at the start and after six months, while patient satisfaction will be evaluated at the six-month follow-up. The study aims to determine if there are significant differences in outcomes between the two attachment types.
Who should consider this trial
Good fit: Ideal candidates are individuals with bilateral mandibular Kennedy Class I edentulism, retaining only the first premolars as abutments.
Not a fit: Patients with systemic diseases affecting bone resorption or those with parafunctional habits like bruxism may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved denture designs that enhance patient satisfaction and periodontal health.
How similar studies have performed: While similar studies have explored different attachment types, this specific comparison of CAD/CAM fiber-reinforced composite versus porcelain-fused-to-metal is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Cairo
- Faculty of Dentistry Ain Shams University — Cairo, Egypt (Recruiting)
Study contacts
- Principal investigator: Omnia M. Refai, PHD — Ain Shams Univeristy
- Study coordinator: Omnia M. Refai, PHD
- Email: omnia_refaie@dent.asu.edu.eg
- Phone: +201202420046
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.