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(PEKK) Framework for Mandibular Implant-supported Complete Fixed Prostheses

Polyether Ketone Ketone (PEKK) Framework for Mandibular Implant-supported Complete Fixed Dental Prostheses With All-on-four Treatment Concept Clinical and Radiographic Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06164990
Enrollment
16
Registered
2023-12-11
Start date
2022-05-10
Completion date
2023-11-10
Last updated
2023-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone Loss, Peri-Implantitis

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

Interventions

OTHERPEKK framework

PEKK (Pekkton) framework in mandibular implant-supported complete fixed dental prostheses with All-on-four treatment concept

Sponsors

Fatma mahanna
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
50 Years to 70 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
peri-implant tissues health (Clinical)1 yearModified gingival index
modified plaque index1 yearperi-implant tissues health (Clinical)
peri-implant probing depth1 yearProbing depth using plastic periodontal probe
Peri-implant radiographic evaluation1 yearMarginal bone height changes using periapical radiograph

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026