Actively Recruiting
A Clinical Trial of Dental Device Made of Zirconia Cemented with PMMA Bone Cement on Partial Edentulous Patients of Kathmandu
Led by Bluebird International Clinic · Updated on 2025-02-14
48
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new dental device made of zirconia, cemented with Polymethyl methacrylate (PMMA) bone cement, to explore if it can serve as an additional option for replacing missing teeth. This clinical trial aims to find a faster and possibly more affordable treatment for edentulism, addressing some shortcomings of conventional bridges and dental implants. The study is an early phase interventional trial focusing on fixed prosthodontics. The trial involves placing the zirconia dental device in edentulous areas of the jaw in 48 participants. The device will be cemented with PMMA bone cement and immediately loaded within 0 to 15 days using single crowns or multiple unit bridges made of zirconia, fixed with luting cement. Participants will be randomly assigned to groups based on the location of their missing teeth: maxillary anterior, maxillary posterior, mandibular anterior, or mandibular posterior regions. Participants will undergo a Cone Beam Computed Tomography (CBCT) scan and clinical evaluation before treatment. After device placement, clinical examinations and radiographic evaluations will be conducted every three months for one year to monitor outcomes like bone loss, gum health, oral hygiene, pain, discomfort, dislodgment, and fractures of the dental device. The entire trial spans 16 months, including follow-up periods to assess device performance and safety.
CONDITIONS
Brief Title
A Clinical Trial of Dental Device Cemented with Polymethyl Methacrylate (PMMA) Bone Cement
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients 18 years old and above who agree to the treatment
- Have single or multiple missing teeth (edentulism)
- Jawbone density greater than 350 Hounsfield Units (HU)
- Edentulous region with at least 2 mm bone width and 5 mm bone height
- Well-controlled diabetes and hypertension
You will not qualify if you...
- Severe or critical medical conditions
- Adults older than 80 years
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 - 0 to 15 days
Participants have a dental device made of zirconia surgically placed and cemented with PMMA bone cement on the edentulous region.
1 surgical visit with immediate loading
Duration - 12 months
Participants undergo radiographic evaluation and clinical examination every three months to monitor the dental device and oral health.
Quarterly visits for 12 months (every 3 months)
Trial Site Locations
Total: 1 location
1
Bluebird International Clinic
Kathmandu, Bagmati, Nepal, 44600
Actively Recruiting
Research Team
P
Parakram Parajuli, DMD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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