Edentulous Mandible
Conditions
Keywords
Mandibular Implant-Supported Overdenture, Cobalt-Chromium bar, Zirconia CAD/CAM bar, Mandibular implants, Crestal bone loss
Brief summary
This randomized clinical trial aimed to evaluate the radiographic and clinical evaluations of mandibular implant-supported overdentures supported d by two different bar materials。 Completely edentulous patients received two implants in the mandibular canine region and were rehabilitated with overdentures supported by a conventional cobalt-chromium bar and a zirconia CAD/CAM bar。 Radiographic marginal bone loss around implants, crestal bone height changes posteriorly and clinical peri-implant parameters were assessed at baseline,6 months, and 12 months to compare the performance of both bar materials。
Detailed description
This randomized clinical trial was conducted to compare the radiographic and clinical outcomes of mandibular implant-supported overdentures supported by conventional cobalt-chromium bars and zirconia CAD/CAM bars。 Eligible completely edentulous patients were selected according to predefined inclusion and exclusion criteria。 All participants received two endosseous dental implants placed in the mandibular canine regions following a standardized surgical protocol。 After a healing period, patients were randomly allocated into two groups。 In the first group, overdentures were supported by using a conventional cast cobalt-chromium bar, while in the second group, overdentures were supported by using a zirconia CAD/CAM-fabricated bar。 Radiographic evaluations of marginal bone loss around implants and crestal bone height changes posteriorly were performed using cone beam computed tomography and clinical peri-implant parameters, including pocket depth, plaque index, bleeding index, and mobility were evaluated at baseline,6 months and after 12 months。 The primary outcome of this study was the evaluation of radiographic marginal bone loss around implants and crestal bone height changes posteriorly, while secondary outcomes included peri-implant soft tissue health parameters。 The collected data were statistically analysed to compare bone stability and clinical performance associated with the two bar materials over the observation period。
Interventions
DEVICECobalt-Chromium Bar Attachment
A conventional cast cobalt-chromium bar used to retain a mandibular implant-supported overdenture
DEVICEZirconia CAD/CAM Bar Attachment
A zirconia CAD/CAM-fabricated bar used to retain a mandibular implant-supported overdenture
Sponsors
Sara Mohamed Fakhry Meligy Mohamed
Al-Azhar University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
50 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* • Patients age range was between 50-60 years old. * Only male patients were selected to participate in this study. * All patients were apparently free from any systemic or debilitating diseases that might affect bone metabolism or delay post-operative healing. * Patients were free from any temporo-mandibular joint disorders. * Patients were free from any neuromuscular or bony disorders, and medically free from any neurologic disorder affecting the neuro-muscular system. * Patients' residual alveolar ridges were covered with firm, healthy mucosa, free from any signs of inflammation, ulceration, or flabby tissue. * Mandibular edentulous alveolar ridge areas had sufficient width and height of alveolar bone. * Patients exhibited Angle Class I maxillo-mandibular relationship and sufficient inter-arch space. * Patients had good oral hygiene. * A period of at least six months up to one year had elapsed from the last extraction.
Exclusion criteria
* • Patients with systemic diseases that might affect bone quality, contribute to bone resorption, increase surgical risk, or delay/complicate post-operative healing. * Patients with parafunctional habits such as bruxism, clenching, or grinding. * Patients with residual ridge covered by inflamed, ulcerated, or flabby mucosa. * Patients with inadequate inter-arch space. * Patients with abnormal tongue behavior and/or size. * Patients with xerostomia or excessive salivation. * Heavy smoker patients and alcoholic patients.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Marginal bone loss around Implants | Baseline,6 months, and 12 months | Radiographic assessment of marginal bone loss around mandibular implants and crestal bone height changes posteriorly using cone-beam computed tomography (CBCT) |
| Posterior crestal bone height changes of the mandibular ridge | Baseline,6months,12months | Radiographic assessment of posterior crestal bone height changes of the mandibular ridge using cone-beam computed tomography (CBCT) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Peri-Implant probing depth | Baseline,6 months, and 12 months | Peri-implant probing depth measured using a calibrated periodontal probe |
| plaque index around implants | Baseline, 6 months, and 12 months | Plaque accumulation around implants assessed using Silness and Löe plaque index |
| Bleeding on probing around implants | Baseline, 6 months, and 12 months | Bleeding on probing around implants assessed using a calibrated periodontal probe |
| Implant mobility | Baseline, 6 months, and 12 months | Implant mobility evaluated using clinical manual assessment (two rigid instrument technique) |
Countries
Egypt
Outcome results
None listed