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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
14
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).
Faculty of Dentistry, Kafrelsheikh University
Kafr ash Shaykh, Kafr el-Sheikh Governorate, Egypt
RECRUITINGMicrobial 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
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