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

October 19, 2024 updated by: Mohammad Eissa Mohammad Irakky, Ain Shams University

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Titanium dental implants group
Two-implants One-piece titanium dental implants with titanium ball attachments retaining mandibular overdentures
Other: One-piece titanium dental implants
One-piece Titanium dental implants with titanium ball attachments, these implants are gold standard compatible implants
Active Comparator: Zirconia dental implants group
Two-implants One-piece zirconia dental implants with zirconia ball attachments retaining mandibular overdentures
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 Names:
  • Z-SYSTEMS
  • ceramic implants

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patients Satisfaction
Time Frame: 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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Investigators

  • Principal Investigator: Mohammad Irakky, masters, Faculty of Dentistry, Benha University
  • Study Director: Omnia M. Refai, PHD, Faculty of dentistry, Ain Shams univeristy
  • Study Director: Noha Helmy Nawar, PHD, Faculty of dentistry, Ain Shams univeristy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2024

Primary Completion (Estimated)

September 15, 2025

Study Completion (Estimated)

October 15, 2025

Study Registration Dates

First Submitted

October 14, 2024

First Submitted That Met QC Criteria

October 14, 2024

First Posted (Actual)

October 16, 2024

Study Record Updates

Last Update Posted (Actual)

October 22, 2024

Last Update Submitted That Met QC Criteria

October 19, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1372

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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