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

NCT ID: NCT06164990

Last Updated: 2023-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-10

Study Completion Date

2023-11-10

Brief Summary

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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

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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

Conditions

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Bone Loss Peri-Implantitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

PEKK framework

Intervention Type OTHER

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

Interventions

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PEKK framework

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fatma mahanna

OTHER

Sponsor Role lead

Responsible Party

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Fatma mahanna

lecturer of prosthodontics

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Faculty of dentistry, mansoura university

Al Mansurah, Dakahlia Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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A01100522

Identifier Type: -

Identifier Source: org_study_id