Health TrialsbyHealthPanel

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

ConditionComplete Edentulism
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-75
SponsorKafrelsheikh University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

1. Patients with systemic conditions that contraindicate implant surgery or may adversely affect osseointegration or wound healing.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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)

  • 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).

Treatment groups

14 Participants
are divided into 2 treatment groups
Group A: Zirconia Framework GroupExperimental treatment 1 intervention
Group B: Zantex Framework GroupExperimental treatment 1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

Modified Plaque Index

Modified Plaque Index (mPI) assessed using a standardized plastic periodontal probe at multiple sites around each implant, scored on a scale from 0 to 3, where higher scores indicate greater plaque accumulation (worse outcome).

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

Modified Bleeding on Probing Index (mBOP)

Modified Bleeding on Probing (mBOP) assessed using a standardized plastic periodontal probe at multiple sites around each implant, scored on a scale from 0 to 3, where higher scores indicate greater bleeding tendency (worse outcome).

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

Probing Depth

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kafrelsheikh University

Lead sponsor

Source ClinicalTrials.gov
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