Microbial Adhesion and Peri-Implant Tissue Health in All-on-Four Hybrid Prostheses Supported by Zantex or Zirconia Frameworks

NCT07811661 | Recruiting

• 1 other identifier: KFSIRB200-722
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

This study compares two materials (Zantex and Zirconia) used to make fixed full-arch dental prostheses supported by four dental implants (the "All-on-Four" technique) in patients who have no natural teeth in the lower jaw. The study will evaluate how much bacteria builds up on each material and how healthy the gum tissue around the implants stays over time. Each patient will receive one type of prosthesis (either Zantex or Zirconia framework), and will be followed for three months after treatment. The goal is to help determine which material may provide better oral health outcomes for patients receiving this type of dental treatment.

Conditions

Complete Edentulism

Keywords

All-on-Four; Dental Implants; Zirconia; Zantex; Peri-implant Tissue Health; Microbial Adhesion; Fixed Full-Arch Prosthesis

Outcome Measures

Primary Outcomes (1)

• Microbial Adhesion on Prosthesis Framework

  Quantitative assessment of bacterial biofilm accumulation on the intaglio surface of the prosthesis framework, measured using microbiological culture/colony counting techniques.

  At 1 week, 1 month, and 3 months after prosthesis delivery

Secondary Outcomes (3)

• Modified Plaque Index

  At 1 week, 2 weeks, 1 month, and 3 months after prosthesis delivery

• Modified Bleeding on Probing Index (mBOP)

  At 1 week, 2 weeks, 1 month, and 3 months after prosthesis delivery

• Probing Depth

  At 1 week, 2 weeks, 1 month, and 3 months after prosthesis delivery

Study Arms (2)

Zirconia Framework Group

EXPERIMENTAL

Mandibular hybrid prosthesis fabricated with Zirconia framework, supported by four implants following the All-on-Four protocol.

Device: Zirconia Framework

Zantex Framework Group

EXPERIMENTAL

Mandibular hybrid prosthesis fabricated with Zantex (fiber-reinforced polymer) framework, supported by four implants following the All-on-Four protocol.

Device: Zantex Framework

Interventions

Zirconia Framework DEVICE

A metal-free zirconia ceramic framework used to fabricate a screw-retained mandibular hybrid prosthesis supported by four dental implants (All-on-Four protocol)

Zirconia Framework Group

Zantex Framework DEVICE

A fiber-reinforced polymer (Zantex) metal-free framework used to fabricate a screw-retained mandibular hybrid prosthesis supported by four dental implants (All-on-Four protocol).

Zantex Framework Group

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Completely edentulous patients in the mandibular arch.
• Patients with a completely edentulous maxillary arch rehabilitated with a conventional complete denture.
• Patients with sufficient mandibular bone volume and quality to allow placement of four implants according to the All-on-Four treatment concept.
• Patients suitable for placement of two axial anterior implants in the canine regions and two distally tilted posterior implants anterior to the mental foramina.
• Patients with adequate restorative space to accommodate a full-arch hybrid prosthesis.
• Patients who are willing and able to maintain adequate oral hygiene and attend all scheduled follow-up appointments.
• Patients who are willing to participate in the study and sign the informed consent form.

You may not qualify if:

• \. Patients with systemic conditions that contraindicate implant surgery or may adversely affect osseointegration or wound healing.
• \. Patients receiving medications or undergoing treatments that significantly affect bone metabolism or healing.
• \. Patients with a history of radiotherapy involving the head and neck region that may compromise implant therapy.
• \. Patients with active or uncontrolled periodontal or oral infections. 5. Patients with inadequate mandibular bone volume or unfavorable anatomical conditions that prevent placement of four implants according to the planned All-on-Four protocol without additional augmentation procedures.
• \. Patients with severe parafunctional habits, such as uncontrolled bruxism, that may compromise the prosthetic rehabilitation.
• \. Patients unable or unwilling to maintain appropriate oral hygiene. 8. Patients unable to attend the scheduled follow-up visits. 9. Patients who decline to participate or fail to provide informed consent

Sponsors & Collaborators

• Kafrelsheikh University: lead

Study Sites (1)

Faculty of Dentistry, Kafrelsheikh University

Kafr ash Shaykh, Kafr el-Sheikh Governorate, 33511, Egypt

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postgraduate Student

Model Details: Patients will be randomly allocated to one of two parallel groups receiving either a Zirconia or Zantex framework for their mandibular hybrid prosthesis.

Study Record Dates

• First Submitted: September 3, 2026
• First Posted: September 10, 2026
• Study Start: August 18, 2026
• Primary Completion (Estimated): March 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: September 10, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)