Microbial Adhesion and Peri-Implant Tissue Health in All-on-Four Hybrid Prostheses Supported by Zantex or Zirconia Frameworks
Microbial Adhesion and Peri-Implant Tissue Health in All-on-Four Hybrid Prosthesis Supported by Zantex or Zirconia Framework. A Randomized Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Kafr el-Sheikh Governorate
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Kafr ash Shaykh, Kafr el-Sheikh Governorate, Egypt, 33511
- Recruiting
- Faculty of Dentistry, Kafrelsheikh University
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Contact:
- Maged Alameri, BDS
- Phone Number: 00201155617217 00201117599298
- Email: majed.alameri.07@hotmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
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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 informed consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Zirconia Framework Group
Mandibular hybrid prosthesis fabricated with Zirconia framework, supported by four implants following the All-on-Four protocol.
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A metal-free zirconia ceramic framework used to fabricate a screw-retained mandibular hybrid prosthesis supported by four dental implants (All-on-Four protocol)
|
|
Experimental: Zantex Framework Group
Mandibular hybrid prosthesis fabricated with Zantex (fiber-reinforced polymer) framework, supported by four implants following the 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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Microbial Adhesion on Prosthesis Framework
Time Frame: At 1 week, 1 month, and 3 months after prosthesis delivery
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Quantitative assessment of bacterial biofilm accumulation on the intaglio surface of the prosthesis framework, measured using microbiological culture/colony counting techniques.
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At 1 week, 1 month, and 3 months after prosthesis delivery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Modified Plaque Index
Time Frame: At 1 week, 2 weeks, 1 month, and 3 months after prosthesis delivery
|
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).
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At 1 week, 2 weeks, 1 month, and 3 months after prosthesis delivery
|
|
Modified Bleeding on Probing Index (mBOP)
Time Frame: At 1 week, 2 weeks, 1 month, and 3 months after prosthesis delivery
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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).
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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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At 1 week, 2 weeks, 1 month, and 3 months after prosthesis delivery
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- KFSIRB200-722
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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