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NCT Number: NCT07812363

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

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.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Complete Edentulism

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Mansoura University

Al Mansurah, Dakahlia Governorate, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Titanium CAD/CAM Framework

Device

CAD/CAM-milled titanium framework used for mandibular All-on-4 implant-supported hybrid prosthesis.

Nano-Carbon CAD/CAM Framework

Device

Nano-carbon fiber-reinforced CAD/CAM framework used for mandibular All-on-4 implant-supported hybrid prosthesis.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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

  3. Probing depth

    Time frame: At prosthesis insertion (T0), 6 months (T6), and 12 months (T12)

    Measure of per-implant probing depth around the implants

  4. Bleeding index

    Time frame: At prosthesis insertion (T0), 6 months (T6), and 12 months (T12)

    Assessment of peri-implant bleeding using the bleeding index

  5. prosthetic complications

    Time frame: up to12 months after prosthesis insertion

    Assessment of prosthetic complications and maintenance requirements associated with the implant supported prosthesis

Interested in participating?

Active, not recruiting

This study is active but is not currently recruiting participants.

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Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Sep 10, 2026
Registry last updated
Sep 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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