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

NCT06643975 | Recruiting DMC

• 1 other identifier: 1372
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Complete Edentulism

Keywords

Zirconia; One-piece; Overdenture; Implant

Outcome Measures

Primary Outcomes (1)

• Crestal bone changes

  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 Outcomes (1)

• Patients Satisfaction

  12 months

Study Arms (2)

Titanium dental implants group

ACTIVE COMPARATOR

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

Other: One-piece titanium dental implants

Zirconia dental implants group

ACTIVE COMPARATOR

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

Other: One-piece zirconia dental implants

Interventions

One-piece zirconia dental implants 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

Also known as: Z-SYSTEMS, ceramic implants

Zirconia dental implants group

One-piece titanium dental implants OTHER

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

Titanium dental implants group

Eligibility Criteria

• Age: 50 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Faculty of Dentistry, Ain Shams University

Cairo, Egypt

RECRUITING

Study Officials

• Mohammad Irakky, masters

  Faculty of Dentistry, Benha University

  PRINCIPAL INVESTIGATOR

• Omnia M. Refai, PHD

  Faculty of Dentistry, Ain Shams Univeristy

  STUDY DIRECTOR

• Noha Helmy Nawar, PHD

  Faculty of Dentistry, Ain Shams Univeristy

  STUDY DIRECTOR

Central Study Contacts

Mohammad Irakky, masters

CONTACT

00201111232777; implanteeth@hotmail.com

Omnia M. Refai, Phd

CONTACT

00201202420046; omnia_refaie@dent.asu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of oral and maxillofacial prosthodontics, faculty of dentistry , Benha University

Study Record Dates

• First Submitted: October 14, 2024
• First Posted: October 16, 2024
• Study Start: June 15, 2024
• Primary Completion: September 15, 2025
• Study Completion: October 15, 2025
• Last Updated: October 22, 2024

Record last verified: 2024-10

Locations

EG (1)