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

NCT ID: NCT06643975

Last Updated: 2024-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-15

Study Completion Date

2025-10-15

Brief Summary

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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

Detailed Description

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Conditions

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Complete Edentulism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Titanium dental implants group

Two-implants One-piece titanium dental implants with titanium ball attachments retaining mandibular overdentures

Group Type ACTIVE_COMPARATOR

One-piece titanium dental implants

Intervention Type OTHER

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

Zirconia dental implants group

Two-implants One-piece zirconia dental implants with zirconia ball attachments retaining mandibular overdentures

Group Type ACTIVE_COMPARATOR

One-piece zirconia dental implants

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

One-piece titanium dental implants

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

Intervention Type OTHER

Other Intervention Names

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Z-SYSTEMS ceramic implants

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Mohammad Eissa Mohammad Irakky

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

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mohammad Irakky, masters

Role: PRINCIPAL_INVESTIGATOR

Faculty of Dentistry, Benha University

Omnia M. Refai, PHD

Role: STUDY_DIRECTOR

Faculty of Dentistry, Ain Shams Univeristy

Noha Helmy Nawar, PHD

Role: STUDY_DIRECTOR

Faculty of Dentistry, Ain Shams Univeristy

Locations

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Faculty of Dentistry, Ain Shams University

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Mohammad Irakky, masters

Role: CONTACT

00201111232777

Omnia M. Refai, Phd

Role: CONTACT

00201202420046

Facility Contacts

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Mohammad Eissa, masters

Role: primary

Omnia Refaie, Phd

Role: backup

00201202420046

Other Identifiers

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1372

Identifier Type: -

Identifier Source: org_study_id

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