Actively Recruiting
Assessment of Patient Satisfaction and Crestal Bone Changes Around One-piece Zirconia and Titanium Implants in Mandibular Implant-Retained Overdenture: A Randomized Clinical Trial
Led by Ain Shams University · Updated on 2024-10-22
20
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating patient satisfaction and changes in crestal bone around one-piece zirconia and titanium dental implants used to retain mandibular overdentures in completely edentulous male patients aged 50 to 60 years. The study aims to find out if there is a significant difference between these two types of implants over a 12-month period following the final prosthetic fitting. Participants will receive either two one-piece titanium dental implants with titanium ball attachments or two one-piece zirconia dental implants with zirconia ball attachments to support the mandibular overdentures. The zirconia implants are metal-free and made from oxide ceramics with advanced surface treatment, while titanium implants are considered the gold standard. This randomized clinical trial compares these two implant types to assess differences in patient outcomes. Throughout the 12 months after the prosthetic loading, researchers will monitor changes in crestal bone and assess patient satisfaction. Participants will have regular follow-up visits to evaluate implant performance and comfort. The study involves careful measurement of bone changes and patient feedback to understand the effects of these implant materials in maintaining mandibular overdentures.
CONDITIONS
Brief Title
Patient Satisfaction and Crestal Bone Changes Around One-piece Zirconia(Zr) and Titanium(Ti) in Implant-Retained Mandibular Overdenture
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male patients
- Age between 50 and 60 years old
- Moderately developed mandibular residual ridges with healthy mucosa firmly attached to the underlying bone
- Average mucosal thickness of 2 to 3 mm
- At least 12 mm of vertical bone height in the mandible for implant placement with 2 mm safety distance to the inferior alveolar nerve
- Angle class-I maxillomandibular relationship with sufficient inter-arch space of 13 to 15 mm
You will not qualify if you...
- Heavy smokers (more than 10 cigarettes per day)
- Poor oral hygiene
- Temporomandibular joint disorders (TMD)
- Xerostomia (dry mouth)
- Para-functional habits or recent dental extractions
- Systemic diseases affecting bone quality, quantity, or wound healing
- Receiving intravenous bisphosphonate treatment
- Previous radiation therapy to the head and neck region
- Existing dental implants in the jaws
- Previous bone grafting in the maxillary or mandibular jaws
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 months
Participants receive either one-piece zirconia or titanium dental implants to retain mandibular overdentures.
Multiple visits for implant placement and assessments over 12 months
Trial Site Locations
Total: 1 location
1
Faculty of Dentistry, Ain Shams University
Cairo, Egypt
Actively Recruiting
Research Team
M
Mohammad Irakky, masters
O
Omnia M. Refai, Phd
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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