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

Peri-Implantitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06164990
• Other study ID #: A01100522
• Status: Completed
• Phase: N/A
• Start date: May 10, 2022
• Est. completion date: November 10, 2023

Study information

• Verified date: December 2023
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: November 10, 2023
• Est. primary completion date: June 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bone Loss
• Peri-Implantitis

Intervention

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

Locations

Country	Name	City	State
Egypt	Faculty of dentistry, mansoura university	Mansoura	Dakahlia

Sponsors (1)

Lead Sponsor	Collaborator
Fatma mahanna

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	peri-implant tissues health (Clinical)	Modified gingival index	1 year
Primary	modified plaque index	peri-implant tissues health (Clinical)	1 year
Primary	peri-implant probing depth	Probing depth using plastic periodontal probe	1 year
Primary	Peri-implant radiographic evaluation	Marginal bone height changes using periapical radiograph	1 year