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

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: Active, not recruiting
• Conditions: Complete Edentulism
• Intervention / Treatment: Device: Titanium CAD/CAM Framework; Device: Nano-Carbon CAD/CAM Framework

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: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Marginal bone level change	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

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

Collaborators and Investigators

• Sponsor: Mansoura University

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2024
• Primary Completion (Actual): August 10, 2026
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: September 5, 2026
• First Submitted That Met QC Criteria: September 5, 2026
• First Posted (Actual): September 10, 2026

Study Record Updates

• Last Update Posted (Actual): September 17, 2026
• Last Update Submitted That Met QC Criteria: September 16, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: CAD/CAM; implant supported prosthesis; prosthetic complications; all-on-4; titanium framework; Nano-Carbon framework; peri-implant tissue
• Other Study ID 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