Assessment of Patient Satisfaction and Crestal Bone Changes Around One-piece Zirconia and Titanium Implants in Mandibular Implant-Retained Overdenture: A Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Ain Shams University
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Crestal bone changes
Study Overview
Brief Summary
This interventional randomized clinical trial study is conducted to assess patient satisfaction and crestal bone changes around one-piece Zr and Ti Implants in mandibular implant-retained overdenture in completely edentulous male patients in the age group between (50-60)years old to know if there will be a significant difference between the two types of dental implants through 12 months after the definitive prosthetic loading
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 50 Years to 60 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Male patients
- •The age range of 50 to 60 years old (average of 55).
- •moderately developed mandibular residual ridges, covered with healthy mucosa, firmly attached to the underling bone and with average mucosal thickness (2-3) mm.
- •At least 12 mm of vertical bone height in the mandible allowing for placement of a 10 mm implant (2 mm safety distance to inferior alveolar nerve).
- •Patients were selected with Angle class-I maxillomandibular relationship with sufficient inter-arch space (13-15mm
Exclusion Criteria
- •Heavy smokers of more than 10 cigarettes a day
- •Poor oral hygiene.
- •Patients with temporomandibular joint disorders(TMD),
- •Patients suffered of xerostomia,
- •Patients exhibited Para-functional habits, or recent extractions were excluded.
- •Patients with systemic diseases that might affect bone quality or quantity, or retard healing of the surgical wounds were excluded.
- •Patients receiving intravenous forms of bisphosphonates.
- •Patients who have had radiation therapy to the head and neck region.
- •Patients with existing implants in the jaws
- •Patients with previous bone grafting in either the maxillary or mandibular jaws.
Arms & Interventions
Titanium dental implants group
Two-implants One-piece titanium dental implants with titanium ball attachments retaining mandibular overdentures
Intervention: One-piece titanium dental implants (Other)
Zirconia dental implants group
Two-implants One-piece zirconia dental implants with zirconia ball attachments retaining mandibular overdentures
Intervention: One-piece zirconia dental implants (Other)
Outcomes
Primary Outcomes
Crestal bone changes
Time Frame: 12 months
Measuring the amount of marginal(crestal) bone changes either loss or gain around the dental implants using the cone beam computed tomography(CBCT) in millimeter scales about the original marginal bone height measured at the time of the visit of final (definitive) prosthetic loading. The positive(+ve) values mean an increase (gain) in the marginal bone height around the implants, the more the +ve value, the more the gain in the bone height which is the better outcome, while the negative (-ve) values mean decrease (loss) in the marginal bone height around the implants, the more the -ve value, the more loss in the bone height, which is the worse outcome.
Secondary Outcomes
- Patients Satisfaction(12 months)
Investigators
Mohammad Eissa Mohammad Irakky
Assistant Lecturer of oral and maxillofacial prosthodontics, faculty of dentistry , Benha University
Benha University