Titanium Versus Nano-Carbon CAD/CAM Frameworks for All-on-4 Implant Supported Hybrid Prosthesis.

September 16, 2026 updated by: Ahmed Farouk Abdelwahed Saleh, Mansoura University

Titanium Versus Nano-Carbon CAD/CAM Frameworks for All-on-4 Implant Supported Hybrid Prosthesis. A Study of Peri-implant Tissue Changes and Prosthetic Complications

This clinical study compares two CAD/CAM framework materials, titanium and nano-carbon fiber-reinforced composite, used in mandibular All-on-4 implant-supported hybrid prostheses. Ten completely edentulous patients are randomly allocated into two equal groups. The study evaluates peri-implant soft tissue health, changes in marginal bone levels,and prosthetic complications over an 12-month follow-up period.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not 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.

Detailed Description

Completely edentulous patients receive four mandibular implants according to the All-on-4 concept, with two anterior axial implants and two posterior tilted implants placed anterior to the mental foramina. Patients are randomly allocated to receive either a CAD/CAM-milled titanium framework or a nano-carbon fiber-reinforced framework. Clinical follow-up includes assessment of modified plaque index, modified gingival index, probing depth, and bleeding index. Marginal bone level changes are assessed radiographically at 6 and 12 months after insertion of the fixed prosthesis. Prosthetic complications are also evaluated.

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 (Actual)

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.
10

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 Locations

  • Egypt
    • Dakahlia Governorate
      • Al Mansurah, Dakahlia Governorate, Egypt
        • Faculty of Dentistry, Mansoura University

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • * Completely edentulous patients requiring mandibular implant-supported rehabilitation.

    • Adequate bone quantity and quality in the mandibular interforaminal region for implant placement.
    • Adequate restorative space for an implant-supported hybrid prosthesis.
    • Healthy oral mucosa and acceptable oral hygiene.
    • Patients medically fit to undergo implant surgery.
    • Ability and willingness to attend the scheduled follow-up visits and provide informed consent.

Exclusion Criteria:

  • Systemic conditions or medical contraindications that could interfere with implant surgery or healing.
  • History of radiotherapy to the head and neck region.
  • Smoking.
  • Alcohol abuse.
  • Bruxism or clenching habits.
  • Any local condition that could compromise implant placement or the planned prosthetic rehabilitation.

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: None (Open Label)

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 Framework Group
Participants received mandibular All-on-4 implant-supported hybrid prostheses fabricated with a CAD/CAM-milled titanium framework.
Device: Titanium CAD/CAM Framework
CAD/CAM-milled titanium framework used for mandibular All-on-4 implant-supported hybrid prosthesis.
Experimental: Nano-Carbon Framework Group
Participants received mandibular All-on-4 implant-supported hybrid prostheses fabricated with a Nano-carbon fiber-reinforced CAD/CAM framework.
Device: Nano-Carbon CAD/CAM Framework
Nano-carbon fiber-reinforced CAD/CAM framework used for mandibular All-on-4 implant-supported hybrid prosthesis.

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
Marginal bone level change
Time Frame: At prosthesis insertion (T0), 6 months (T6), and 12 months (T12)
Radiographic assessment of changes in peri-implant marginal bone level around the implants in the titanium and nano-carbon framework groups.
At prosthesis insertion (T0), 6 months (T6), and 12 months (T12)

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
Modified plaque index
Time Frame: At prosthesis insertion (T0), 6 months (T6), and 12 months (T12)
Assessment of plaque accumulation around the implants using the modified plaque index
At prosthesis insertion (T0), 6 months (T6), and 12 months (T12)
Modified gingival index
Time Frame: At prosthesis insertion (T0), 6 months (T6), and 12 months (T12)
Assessment of peri-implant gingival tissue condition using the modified gingival index
At prosthesis insertion (T0), 6 months (T6), and 12 months (T12)
Probing depth
Time Frame: At prosthesis insertion (T0), 6 months (T6), and 12 months (T12)
Measure of per-implant probing depth around the implants
At prosthesis insertion (T0), 6 months (T6), and 12 months (T12)
Bleeding index
Time Frame: At prosthesis insertion (T0), 6 months (T6), and 12 months (T12)
Assessment of peri-implant bleeding using the bleeding index
At prosthesis insertion (T0), 6 months (T6), and 12 months (T12)
prosthetic complications
Time Frame: up to12 months after prosthesis insertion
Assessment of prosthetic complications and maintenance requirements associated with the implant supported prosthesis
up to12 months after prosthesis insertion

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.
Mansoura University

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.
May 6, 2024

Primary Completion (Actual)

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.
August 10, 2026

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.
February 1, 2027

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).
September 5, 2026

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.
September 5, 2026

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.
September 10, 2026

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.
September 17, 2026

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.
September 16, 2026

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.
September 1, 2026

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.
  • A0102024RP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data are not planned to be shared because the study was conducted as part of an academic doctoral research project and no data-sharing plan was established in the approved protocol.

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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