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

December 8, 2023 updated by: Fatma mahanna

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Dakahlia
      • Mansoura, Dakahlia, Egypt, 35511
        • Faculty of Dentistry, Mansoura University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Other: PEKK framework
PEKK (Pekkton) framework in mandibular implant-supported complete fixed dental prostheses with All-on-four treatment concept

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fatma mahanna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 10, 2022

Primary Completion (Actual)

June 15, 2023

Study Completion (Actual)

November 10, 2023

Study Registration Dates

First Submitted

December 2, 2023

First Submitted That Met QC Criteria

December 8, 2023

First Posted (Estimated)

December 11, 2023

Study Record Updates

Last Update Posted (Estimated)

December 11, 2023

Last Update Submitted That Met QC Criteria

December 8, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A01100522

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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