Complete Edentulism
Conditions
Keywords
Zirconia, One-piece, Overdenture, Implant
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
Interventions
OTHEROne-piece zirconia dental implants
One-piece zirconia dental implants with zirconia ball attachments, these implants are metal free made of oxide ceramics with cutting-edge Selective laser melting(SLM) surface treatment technology
OTHEROne-piece titanium dental implants
One-piece Titanium dental implants with titanium ball attachments, these implants are gold standard compatible implants
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
50 Years to 60 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Crestal bone changes | 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
| Measure | Time frame | Description |
|---|---|---|
| Patients Satisfaction | 12 months | measuring the degree of patient satisfaction using a Patient's Denture Assessment (PDA) questionnaire, via a Likert scale which uses a 5-point system from 1 to 5, All items are scored as follows: unsatisfactory =1 hardly satisfactory =2 moderately satisfactory=3 very satisfactory=4 excellent satisfaction=5 The greater (higher) the score, the more patient satisfaction, which is the better outcome, while the weaker (lower) the score, the less is patient satisfaction, which is the worse outcome. |
Countries
Egypt
Contacts
Primary ContactMohammad Irakky, masters
Backup ContactOmnia M. Refai, Phd
Outcome results
None listed