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

Not Applicable

Completed

• Conditions: Peri-Implantitis; Bone Loss

• Registration Number: NCT06164990
• Lead Sponsor: Fatma mahanna

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 Timeline

• Study Start: 2022-05-10
• Primary Completion: 2023-06-15
• Study Completion: 2023-11-10
• Status Verified: 2023-12
• Study First Submitted: 2023-12-02
• Study First Submitted QC: 2023-12-08
• Last Update Submitted: 2023-12-08
• Study First Posted: 2023-12-11
• Last Update Posted: 2023-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
peri-implant probing depth	1 year	Probing depth using plastic periodontal probe
Peri-implant radiographic evaluation	1 year	Marginal bone height changes using periapical radiograph
modified plaque index	1 year	peri-implant tissues health (Clinical)
peri-implant tissues health (Clinical)	1 year	Modified gingival index

Trial Locations

Locations (1)

Faculty of dentistry, mansoura university; 🇪🇬 Mansoura, Dakahlia, Egypt