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Completed

NCT Number: NCT06164990

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

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

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Key information

Age range

50 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of dentistry, mansoura university

Al Mansurah, Dakahlia Governorate, 35511, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PEKK framework

Other

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

Primary outcomes

  1. peri-implant tissues health (Clinical)

    Time frame: 1 year

    Modified gingival index

  2. modified plaque index

    Time frame: 1 year

    peri-implant tissues health (Clinical)

  3. peri-implant probing depth

    Time frame: 1 year

    Probing depth using plastic periodontal probe

  4. Peri-implant radiographic evaluation

    Time frame: 1 year

    Marginal bone height changes using periapical radiograph

Sponsors and collaborators

Lead sponsor

Fatma mahanna

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 11, 2023
Registry last updated
Dec 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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