Clinical trial NCT06017596: CAD-CAM PEEK Framework for All-on-4 Implants
Official title: Evaluation of Polyetheretherketone (PEEK) Framework Inserted in Multiunit Abutments of All-on-4 Concept for the Mandibular Edentulous Arch.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bone Loss
Keywords: All-on-Four implant
CAD-CAM
PEEK framework
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2023-08-30
Enrollment: 16
Sex: ALL
Minimum age (years): 60
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study was conducted to evaluate the clinical peri-implant soft tissue changes during the first year after occlusal loading and the ridge base relation after 3 years for mandibular computer-aided design and computer-aided manufacturing (CAD/CAM) screw-retained implant-supported hybrid prosthesis of polyetheretherketone (PEEK) framework utilized with All-on-Four treatment concept.

Detailed description: Sixteen completely edentulous patients were rehabilitated by four implants following the All-on-Four protocol. After 3 months, the definitive prosthesis was constructed to be a screw-retained CAD-CAM milled framework from the modified PEEK (BioHPP), bonded to polymethylmethacrylate teeth and a pink-shaded indirect light-polymerized nano-filled composite resin imitating the soft tissues. Peri-implant soft tissue changes regarding plaque, bleeding, gingival scores, and probing depth were evaluated at prosthesis insertion (T0), 6 months (T1), and 12 months (T2) after insertion. Also, monitoring of the ridge base relation was performed using cone-beam computed tomography CBCT at the time of insertion (T0), and 1 year (T1), 2 years (T2), and 3 years (T3) after mandibular fixed detachable All-on-Four framework insertion.

Eligibility criteria: Inclusion Criteria:

* Completely edentulous maxillary and mandibular ridges with sufficient mandibular bone height in the inter-foraminal area confirmed with panoramic x-rays.
* All selected patients will be with sufficient inter-arch space and restorative space.
* All selected patients will have apparently healthy ridge covered by compressible oral mucosa and free from any ridge flabbiness.

Exclusion Criteria:

* Patients with systemic diseases that contraindicate implant placement such as hematologic diseases, serious problems of coagulation and diseases of the immune system. Also, metabolic diseases related to bone resorption such as uncontrolled diabetics or osteoporosis will be also excluded
* History of para-functional habits (Bruxism, clenching), smoking and alcoholism.
* History of radiation therapy in the head and neck region.

Primary outcomes:
measure: evaluation of changes in the peri-implant soft tissue health
timeFrame: six months
measure: evaluation of changes in the peri-implant soft tissue health
timeFrame: six months
measure: evaluation of changes in the peri-implant soft tissue health
timeFrame: six months
Secondary outcomes:
measure: Ridge base relation monitoring
timeFrame: 3 years
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Khloud Ezzat
Study officials:
affiliation: Lecturer of Prosthodontics
name: Khloud Ezzat, PhD
role: PRINCIPAL_INVESTIGATOR
References: