About this trial
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
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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).
Disqualifiers
Heavy smokers of more than 10 cigarettes a day
Poor oral hygiene.
Patients with temporomandibular joint disorders(TMD),
Patients suffered of xerostomia,
Trial design
Parallel
Treatments tested in this trial
One-piece zirconia dental implants
Other interventionOne-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
One-piece titanium dental implants
Other interventionOne-piece Titanium dental implants with titanium ball attachments, these implants are gold standard compatible implants
Treatment groups
Trial outcomes
Primary outcomes
Crestal bone changes
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
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.
Sponsors and contacts
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Ain Shams University
Lead sponsor
Benha University
Sponsor institution