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CompletedNCT07429149Updated Feb 24, 2026

Radiographic and Clinical Evaluations of Mandibular Implant-Supported Overdentures Supported by Conventional and Zirconia CAD/CAM Bars: A Randomized Clinical Trial

An interventional study of Cobalt-Chromium Bar Attachment and Zirconia CAD/CAM Bar Attachment in Edentulous Mandible, sponsored by Sara Mohamed Fakhry Meligy Mohamed. Completed at 1 site in Egypt. Open to male participants aged 50 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-24.

Sponsored by Sara Mohamed Fakhry Meligy Mohamed · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 3 years 6 months after the study started (first participant enrolled Jul 2022, registered Feb 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Randomized
Ages
50 Years to 60 Years
Sex
Male
01

Study summary

This randomized clinical trial aimed to evaluate the radiographic and clinical evaluations of mandibular implant-supported overdentures supported d by two different bar materials。 Completely edentulous patients received two implants in the mandibular canine region and were rehabilitated with overdentures supported by a conventional cobalt-chromium bar and a zirconia CAD/CAM bar。 Radiographic marginal bone loss around implants, crestal bone height changes posteriorly and clinical peri-implant parameters were assessed at baseline,6 months, and 12 months to compare the performance of both bar materials。

Read the detailed description

This randomized clinical trial was conducted to compare the radiographic and clinical outcomes of mandibular implant-supported overdentures supported by conventional cobalt-chromium bars and zirconia CAD/CAM bars。 Eligible completely edentulous patients were selected according to predefined inclusion and exclusion criteria。

All participants received two endosseous dental implants placed in the mandibular canine regions following a standardized surgical protocol。 After a healing period, patients were randomly allocated into two groups。 In the first group, overdentures were supported by using a conventional cast cobalt-chromium bar, while in the second group, overdentures were supported by using a zirconia CAD/CAM-fabricated bar。

Radiographic evaluations of marginal bone loss around implants and crestal bone height changes posteriorly were performed using cone beam computed tomography and clinical peri-implant parameters, including pocket depth, plaque index, bleeding index, and mobility were evaluated at baseline,6 months and after 12 months。

The primary outcome of this study was the evaluation of radiographic marginal bone loss around implants and crestal bone height changes posteriorly, while secondary outcomes included peri-implant soft tissue health parameters。 The collected data were statistically analysed to compare bone stability and clinical performance associated with the two bar materials over the observation period。

02

Conditions studied

  • Edentulous Mandible

Keywords

  • Mandibular Implant-Supported Overdenture
  • Cobalt-Chromium bar
  • Zirconia CAD/CAM bar
  • Mandibular implants
  • Crestal bone loss
03

In context

Lead sponsor

This is the only study on the registry with Sara Mohamed Fakhry Meligy Mohamed as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 60 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

    • Patients age range was between 50-60 years old.

      • Only male patients were selected to participate in this study.
      • All patients were apparently free from any systemic or debilitating diseases that might affect bone metabolism or delay post-operative healing.
      • Patients were free from any temporo-mandibular joint disorders.
      • Patients were free from any neuromuscular or bony disorders, and medically free from any neurologic disorder affecting the neuro-muscular system.
      • Patients' residual alveolar ridges were covered with firm, healthy mucosa, free from any signs of inflammation, ulceration, or flabby tissue.
      • Mandibular edentulous alveolar ridge areas had sufficient width and height of alveolar bone.
      • Patients exhibited Angle Class I maxillo-mandibular relationship and sufficient inter-arch space.
      • Patients had good oral hygiene.
      • A period of at least six months up to one year had elapsed from the last extraction.

Exclusion criteria

Exclusion Criteria:

    • Patients with systemic diseases that might affect bone quality, contribute to bone resorption, increase surgical risk, or delay/complicate post-operative healing.

      • Patients with parafunctional habits such as bruxism, clenching, or grinding.
      • Patients with residual ridge covered by inflamed, ulcerated, or flabby mucosa.
      • Patients with inadequate inter-arch space.
      • Patients with abnormal tongue behavior and/or size.
      • Patients with xerostomia or excessive salivation.
      • Heavy smoker patients and alcoholic patients.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
12 participants (actual)

Study arms

  • Experimental
    Conventional Cobalt-Chromium Bar

    participants received mandibular implant-supported overdentures supported by a conventional cast cobalt-chromium bar

    Device: Cobalt-Chromium Bar Attachment

  • Experimental
    Zirconia CAD/CAM Bar

    participants received mandibular implant-supported overdentures supported by a Zirconia CAD/CAM-fabricated bar

    Device: Zirconia CAD/CAM Bar Attachment

Interventions

  • DeviceCobalt-Chromium Bar Attachment

    A conventional cast cobalt-chromium bar used to retain a mandibular implant-supported overdenture

  • DeviceZirconia CAD/CAM Bar Attachment

    A zirconia CAD/CAM-fabricated bar used to retain a mandibular implant-supported overdenture

06

What researchers measure

Primary outcomes

  1. Marginal bone loss around Implants

    Radiographic assessment of marginal bone loss around mandibular implants and crestal bone height changes posteriorly using cone-beam computed tomography (CBCT)

    Time frame: Baseline,6 months, and 12 months

  2. Posterior crestal bone height changes of the mandibular ridge

    Radiographic assessment of posterior crestal bone height changes of the mandibular ridge using cone-beam computed tomography (CBCT)

    Time frame: Baseline,6months,12months

Secondary outcomes

  1. Peri-Implant probing depth

    Peri-implant probing depth measured using a calibrated periodontal probe

    Time frame: Baseline,6 months, and 12 months

  2. plaque index around implants

    Plaque accumulation around implants assessed using Silness and Löe plaque index

    Time frame: Baseline, 6 months, and 12 months

  3. Bleeding on probing around implants

    Bleeding on probing around implants assessed using a calibrated periodontal probe

    Time frame: Baseline, 6 months, and 12 months

  4. Implant mobility

    Implant mobility evaluated using clinical manual assessment (two rigid instrument technique)

    Time frame: Baseline, 6 months, and 12 months

07

Study locations

1 site
  • Faculty of Dental Medicine for Girls, Al-Azhar University
    Cairo, Nasr City, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07429149
Lead sponsor
Sara Mohamed Fakhry Meligy Mohamed
Collaborators
Al-Azhar University
Responsible party
Sara Mohamed Fakhry Meligy Mohamed (Assistant Lecturer of Removable Prosthodontics, Al-Azhar University) — Sponsor-investigator
First posted
Feb 24, 2026
Start date
Jul 18, 2022
Primary completion
Jun 17, 2025
Completion
Jun 19, 2025
Last update
Feb 24, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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