Patient Satisfaction and Crestal Bone Changes Around One-piece Zirconia(Zr) and Titanium(Ti) in Implant-Retained Mandibular Overdenture

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age50-60
SponsorAin Shams University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • One-piece zirconia dental implants

    Other intervention

    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

  • One-piece titanium dental implants

    Other intervention

    One-piece Titanium dental implants with titanium ball attachments, these implants are gold standard compatible implants

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Titanium dental implants groupActive comparator 1 intervention
Group B: Zirconia dental implants groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
12 months

Secondary outcomes

1

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.

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ain Shams University

Lead sponsor

Benha University

Sponsor institution