Clinical trial NCT06164990: (PEKK) Framework for Mandibular Implant-supported Complete Fixed Prostheses
Official title: Polyether Ketone Ketone (PEKK) Framework for Mandibular Implant-supported Complete Fixed Dental Prostheses With All-on-four Treatment Concept Clinical and Radiographic Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bone Loss
Peri-Implantitis
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2023-12-11
Enrollment: 16
Sex: ALL
Minimum age (years): 50
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 clinical study aims to evaluate the effect of using PEKK (Pekkton) framework in mandibular implant-supported complete fixed dental prostheses with All-on-four treatment concept on peri-implant tissues health

Detailed description: The aim of this clinical study is to evaluate the effect of using PEKK (Pekkton) framework in mandibular implant-supported complete fixed dental prostheses with All-on-four treatment concept on peri-implant tissues health regarding the following parameters:

* Modified Plaque index
* Modified Gingival index
* Peri-implant probing pocket depth

Radiographic evaluation (periapical x-ray):

Marginal bone height changes

Eligibility criteria: Inclusion Criteria:

* Maxillary and mandibular alveolar ridges were covered with healthy, firm, relatively even thickness and even compressible mucosa and free from any signs of inflammation or flabbiness.
* Patients had completely edentulous maxillary and mandibular ridges with sufficient mandibular bone height not less than 15 mm in the interforaminal area and at least 12mm posteriorly
* All patients had sufficient inter-arch space
* All patients complained of insufficient retention and stability of their conventional mandibular dentures.
* All patients were of Angel's class I maxillo-mandibular relationship.

Exclusion Criteria:

* Patients with absolute contraindications for implant placement, such as active cancer and diseases of the immune system.
* Patients with metabolic diseases that are directly related to bone resorption, such as uncontrolled diabetes, osteoporosis, and hyperparathyroidism.
* Patients with general contraindications for surgical procedures, such as hematologic diseases, hepatic patients, patients with bleeding disorders, and serious problems with coagulation.
* Patients with a history of irradiation of the head and neck region or chemotherapy in the last 3 years were also excluded.
* Patients with relative contraindications such as a history of parafunctional habits (such as bruxism and clenching), smoking, alcoholism, and patients with any physical reasons that could affect follow-up.
* Patients with local contraindications for implant placement, such as localized bone defects.

Primary outcomes:
measure: peri-implant tissues health (Clinical)
timeFrame: 1 year
measure: modified plaque index
timeFrame: 1 year
measure: peri-implant probing depth
timeFrame: 1 year
measure: Peri-implant radiographic evaluation
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Faculty of dentistry, mansoura university
state: Dakahlia
Study officials:
References: