Mandibular Distal-extension Prostheses
Conditions
Keywords
CAD/CAM, Fiber Reinforced Composite, Denture Precision Attachment, Denture, Partial, Removable
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 and twelve months. Patient satisfaction will also be evaluated at the twelve-month follow-up.
Interventions
OTHERMandibular 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.
OTHERMandibular 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.
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of Bleeding index | 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). |
| Evaluation of Probing Pocket Depth (PPD) | 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. |
| Evaluation Gingival Index (GI) | 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
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of Patient Satisfaction | 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. |
Countries
Egypt
Contacts
PRINCIPAL_INVESTIGATOROmnia M. Refai, PHD
Ain Shams Univeristy
STUDY_DIRECTORNoha Helmy Hassan Nawar, PHD
Ain Shams Univeristy
PRINCIPAL_INVESTIGATORHeba A. Salama, PHD
Misr International University
PRINCIPAL_INVESTIGATORAbdel Rahman Maged, PHD
Misr International University
Outcome results
None listed