An interventional study of Zirconia Framework and Zantex Framework in Complete Edentulism, sponsored by Kafrelsheikh University. Recruiting at 1 site in Egypt. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-10.
Sponsored by Kafrelsheikh University · Not applicable, Interventional, and Treatment
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.
Complete edentulism remains a major clinical challenge, particularly among aging populations. All-on-Four fixed implant-supported prostheses have become a widely used solution, but the long-term success of these restorations depends heavily on the framework material used, including its resistance to microbial adhesion and its effect on peri-implant tissue health.
This randomized clinical trial compares two framework materials: Zirconia, a high-strength ceramic material, and Zantex, a fiber-reinforced polymer material, both used to fabricate mandibular hybrid prostheses supported by four implants placed following the All-on-Four protocol.
Microbial adhesion will be assessed by evaluating biofilm accumulation on the prosthesis frameworks retrieved under sterile conditions at set time intervals. Peri-implant tissue health will be evaluated clinically at 1 week, 2 weeks, 1 month, and 3 months following prosthesis delivery, using standard clinical parameters including modified plaque index, modified bleeding on probing, and probing depth.
A total of 14 patients (7 per group) will be enrolled based on sample size calculations targeting 90% statistical power.
Kafrelsheikh University is the lead sponsor of 294 studies on the registry; 114 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients who are willing to participate in the study and sign the form.
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Exclusion Criteria:
1. Patients with systemic conditions that contraindicate implant surgery or may adversely affect osseointegration or wound healing.
2. Patients receiving medications or undergoing treatments that significantly affect bone metabolism or healing.
3. Patients with a history of radiotherapy involving the head and neck region that may compromise implant therapy.
4. 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.
6. Patients with severe parafunctional habits, such as uncontrolled bruxism, that may compromise the prosthetic rehabilitation.
7. 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
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Mandibular hybrid prosthesis fabricated with Zirconia framework, supported by four implants following the All-on-Four protocol.
Device: Zirconia Framework
Mandibular hybrid prosthesis fabricated with Zantex (fiber-reinforced polymer) framework, supported by four implants following the All-on-Four protocol.
Device: Zantex Framework
A metal-free zirconia ceramic framework used to fabricate a screw-retained mandibular hybrid prosthesis supported by four dental implants (All-on-Four protocol)
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).
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
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
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
Probing Depth
Time frame: At 1 week, 2 weeks, 1 month, and 3 months after prosthesis delivery
Plan to share: No
No publications or documents are linked to this record.
Started Aug 2026 (actual). Primary completion is estimated for Mar 2027, 7 months after the start.
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