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Clinical Trials/NCT06643975
NCT06643975
Recruiting
Not Applicable

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

Ain Shams University1 site in 1 country20 target enrollmentJune 15, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Complete Edentulism
Sponsor
Ain Shams University
Enrollment
20
Locations
1
Primary Endpoint
Crestal bone changes
Status
Recruiting
Last Updated
last year

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

Registry
clinicaltrials.gov
Start Date
June 15, 2024
End Date
October 15, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mohammad Eissa Mohammad Irakky

Assistant Lecturer of oral and maxillofacial prosthodontics, faculty of dentistry , Benha University

Benha University

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.

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)

Study Sites (1)

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