Complete EdentulismNCT07811661
Microbial Adhesion and Peri-Implant Tissue Health in All-on-Four Hybrid Prostheses Supported by Zantex or Zirconia Frameworks
A study testing Zirconia Framework and Zantex Framework in people with Complete Edentulism, run by Kafrelsheikh University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Complete Edentulism
- What is being tested?
- Zirconia Framework and Zantex Framework
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteEgypt
- Study dates
- 18 Aug 2026to 30 Jun 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- -
Who cannot join
- 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 informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dentistry, Kafrelsheikh University
Kafr ash Shaykh, Kafr el-Sheikh Governorate, 33511
Maged Alameri, BDS, 00201117599298 ext. 00201155617217, majed.alameri.07@hotmail.com
About this study
Official title: Microbial Adhesion and Peri-Implant Tissue Health in All-on-Four Hybrid Prosthesis Supported by Zantex or Zirconia Framework. A Randomized Clinical 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.
Read the detailed description
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.
- Conditions
- Complete Edentulism
- Being tested
- Zirconia Framework, Zantex Framework
- Keywords
- All-on-Four, Dental Implants, Zirconia, Zantex, Peri-implant Tissue Health, Microbial Adhesion, Fixed Full-Arch Prosthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zirconia FrameworkDevice
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 FrameworkDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| Zirconia Framework Group | Experimental | Mandibular hybrid prosthesis fabricated with Zirconia framework, supported by four implants following the All-on-Four protocol. Receives: 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. Receives: Device: Zantex Framework |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 1 week, 1 month, and 3 months after prosthesis delivery
Secondary outcomes (3)
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).
Measured: 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).
Measured: At 1 week, 2 weeks, 1 month, and 3 months after prosthesis delivery
Probing Depth
Measured: At 1 week, 2 weeks, 1 month, and 3 months after prosthesis delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study start18 Aug 2026
- Primary completion30 Mar 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complete EdentulismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomly allocated to one of two parallel groups receiving either a Zirconia or Zantex framework for their mandibular hybrid prosthesis.
- Masking
- None (open label)
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maged Alameri, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07811661
- Sponsor's protocol ID
- KFSIRB200-722
- Status last verified
- Sep 2025
- First submitted
- 3 Sep 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No