Edentulous MandibleNCT07429149
Radiographic and Clinical Evaluations of Mandibular Implant-Supported Overdentures Supported by Conventional and Zirconia CAD/CAM Bars: A Randomized Clinical Trial
A study testing Cobalt-Chromium Bar Attachment and Zirconia CAD/CAM Bar Attachment in people with Edentulous Mandible, run by Sara Mohamed Fakhry Meligy Mohamed at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Edentulous Mandible
- What is being tested?
- Cobalt-Chromium Bar Attachment and Zirconia CAD/CAM Bar Attachment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteEgypt
- Study dates
- 18 Jul 2022to 19 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- • 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.
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- 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.
Who cannot join
- • 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Dental Medicine for Girls, Al-Azhar University
Cairo, Nasr City
About this study
Official title: Evaluation Of Mandibular Implant-Supported Overdenture: A Comparative Study of Conventional Bar Versus Zirconia CAD/CAM Bars
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。
- Conditions
- Edentulous Mandible
- Being tested
- Cobalt-Chromium Bar Attachment, Zirconia CAD/CAM Bar Attachment
- Keywords
- Mandibular Implant-Supported Overdenture, Cobalt-Chromium bar, Zirconia CAD/CAM bar, Mandibular implants, Crestal bone loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cobalt-Chromium Bar AttachmentDevice
A conventional cast cobalt-chromium bar used to retain a mandibular implant-supported overdenture
Zirconia CAD/CAM Bar AttachmentDevice
A zirconia CAD/CAM-fabricated bar used to retain a mandibular implant-supported overdenture
| Study group | Role | What they receive |
|---|---|---|
| Conventional Cobalt-Chromium Bar | Experimental | participants received mandibular implant-supported overdentures supported by a conventional cast cobalt-chromium bar Receives: Device: Cobalt-Chromium Bar Attachment |
| Zirconia CAD/CAM Bar | Experimental | participants received mandibular implant-supported overdentures supported by a Zirconia CAD/CAM-fabricated bar Receives: Device: Zirconia CAD/CAM Bar Attachment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline,6 months, and 12 months
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)
Measured: Baseline,6months,12months
Secondary outcomes (4)
Peri-Implant probing depth
Peri-implant probing depth measured using a calibrated periodontal probe
Measured: Baseline,6 months, and 12 months
plaque index around implants
Plaque accumulation around implants assessed using Silness and Löe plaque index
Measured: Baseline, 6 months, and 12 months
Bleeding on probing around implants
Bleeding on probing around implants assessed using a calibrated periodontal probe
Measured: Baseline, 6 months, and 12 months
Implant mobility
Implant mobility evaluated using clinical manual assessment (two rigid instrument technique)
Measured: Baseline, 6 months, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study start18 Jul 2022
- Primary completion17 Jun 2025
- Study completion19 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Edentulous MandibleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sara Mohamed Fakhry Meligy Mohamed
- Sponsor type
- University, hospital or other
- Collaborators
- Al-Azhar University
- Responsible party
- Sponsor-investigator, Sara Mohamed Fakhry Meligy Mohamed, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07429149
- Sponsor's protocol ID
- P-PR-22-02
- Status last verified
- Feb 2026
- First submitted
- 3 Feb 2026
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Of Mandibular Implant-Supported Overdenture: A Comparative Study of Conventional Bar Versus Zirconia CAD/CAM Bars
- ClinicalTrials.gov ID
- NCT07429149
- Acronym / sponsor ID
- P-PR-22-02
- Conditions
- Edentulous Mandible
- Keywords
- Mandibular Implant-Supported Overdenture, Cobalt-Chromium bar, Zirconia CAD/CAM bar, Mandibular implants, Crestal bone loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Sara Mohamed Fakhry Meligy MohamedUniversity, hospital or other
- Collaborators
- Al-Azhar University
- Study start
- 18 Jul 2022 (actual)
- Primary completion
- 17 Jun 2025 (actual)
- Study completion
- 19 Jun 2025 (actual)
- First posted
- 24 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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。
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。
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Cobalt-Chromium Bar | Experimental | Device: Cobalt-Chromium Bar Attachmentparticipants received mandibular implant-supported overdentures supported by a conventional cast cobalt-chromium bar |
| Zirconia CAD/CAM Bar | Experimental | Device: Zirconia CAD/CAM Bar Attachmentparticipants received mandibular implant-supported overdentures supported by a Zirconia CAD/CAM-fabricated bar |
Who may qualify
- Ages
- 50 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- • Patients age range was between 50-60 years old.
Key exclusion criteria (7 listed)
- • Patients with systemic diseases that might affect bone quality, contribute to bone resorption, increase surgical risk, or delay/complicate post-operative healing.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cobalt-Chromium Bar AttachmentA conventional cast cobalt-chromium bar used to retain a mandibular implant-supported overdenture | Device | Conventional Cobalt-Chromium Bar |
| Zirconia CAD/CAM Bar AttachmentA zirconia CAD/CAM-fabricated bar used to retain a mandibular implant-supported overdenture | Device | Zirconia CAD/CAM Bar |
Primary outcome
Marginal bone loss around Implants
Time frame: Baseline,6 months, and 12 months
Radiographic assessment of marginal bone loss around mandibular implants and crestal bone height changes posteriorly using cone-beam computed tomography (CBCT)
Posterior crestal bone height changes of the mandibular ridge
Time frame: Baseline,6months,12months
Radiographic assessment of posterior crestal bone height changes of the mandibular ridge using cone-beam computed tomography (CBCT)
4 secondary outcomes
Peri-Implant probing depth
Time frame: Baseline,6 months, and 12 months
plaque index around implants
Time frame: Baseline, 6 months, and 12 months
Bleeding on probing around implants
Time frame: Baseline, 6 months, and 12 months
Implant mobility
Time frame: Baseline, 6 months, and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cobalt-Chromium Bar Attachment and Zirconia CAD/CAM Bar Attachment in people with Edentulous Mandible, run by Sara Mohamed Fakhry Meligy Mohamed at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Marginal bone loss around Implants (time frame: Baseline,6 months, and 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2026.