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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ain Shams University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 15, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 15, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 15, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 14, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 14, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 16, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 22, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 19, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

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Drug Interventions

Dietary Supplements

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Locations

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