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Recruiting NCT06643975

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

No phase Interventional Complete Edentulism

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: One-piece zirconia dental implants, One-piece titanium dental implants.
Who it may be relevant to
Registry conditions: Complete Edentulism. Basic parameters: 50 years — 60 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Assessment of Patient Satisfaction and Crestal Bone Changes Around One-piece Zirconia and Titanium Implants in Mandibular Implant-Retained Overdenture: A Randomized Clinical Trial

Overview

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

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

Primary outcome measures

  • Crestal bone changes [Time frame: 12 months]
Secondary outcome measures (1)
  • Patients Satisfaction [Time frame: 12 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Faculty of Dentistry, Ain Shams University — Cairo

Identifiers

NCT: NCT06643975 · 1372

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗