Polyether Ketone Ketone (PEKK) Framework for Mandibular Implant-supported Complete Fixed Dental Prostheses With All-on-four Treatment Concept Clinical and Radiographic Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- peri-implant probing depth
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 50 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
PEKK (Pekkton) framework
PEKK (Pekkton) framework in mandibular implant-supported complete fixed dental prostheses with All-on-four treatment concept and evaluated regarding peri-implant tissue health
Intervention: PEKK framework (Other)
Outcomes
Primary Outcomes
peri-implant probing depth
Time Frame: 1 year
Probing depth using plastic periodontal probe
Peri-implant radiographic evaluation
Time Frame: 1 year
Marginal bone height changes using periapical radiograph
peri-implant tissues health (Clinical)
Time Frame: 1 year
Modified gingival index
modified plaque index
Time Frame: 1 year
peri-implant tissues health (Clinical)
Secondary Outcomes
No secondary outcomes reported
Investigators
Fatma mahanna
lecturer of prosthodontics
Mansoura University