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Completed

NCT Number: NCT06017596

CAD-CAM PEEK Framework for All-on-4 Implants

This study was conducted to evaluate the clinical peri-implant soft tissue changes during the first year after occlusal loading and the ridge base relation after 3 years for mandibular computer-aided design and computer-aided manufacturing (CAD/CAM) screw-retained implant-supported hybrid prosthesis of polyetheretherketone (PEEK) framework utilized with All-on-Four treatment concept.

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Key information

Age range

60 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Khloud Ezzat

Al Mansurah, 54790, Egypt

About this study

Sixteen completely edentulous patients were rehabilitated by four implants following the All-on-Four protocol. After 3 months, the definitive prosthesis was constructed to be a screw-retained CAD-CAM milled framework from the modified PEEK (BioHPP), bonded to polymethylmethacrylate teeth and a pink-shaded indirect light-polymerized nano-filled composite resin imitating the soft tissues. Peri-implant soft tissue changes regarding plaque, bleeding, gingival scores, and probing depth were evaluated at prosthesis insertion (T0), 6 months (T1), and 12 months (T2) after insertion. Also, monitoring of the ridge base relation was performed using cone-beam computed tomography CBCT at the time of insertion (T0), and 1 year (T1), 2 years (T2), and 3 years (T3) after mandibular fixed detachable All-on-Four framework insertion.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Completely edentulous maxillary and mandibular ridges with sufficient mandibular bone height in the inter-foraminal area confirmed with panoramic x-rays.
  • All selected patients will be with sufficient inter-arch space and restorative space.
  • All selected patients will have apparently healthy ridge covered by compressible oral mucosa and free from any ridge flabbiness.

Exclusion criteria

  • Patients with systemic diseases that contraindicate implant placement such as hematologic diseases, serious problems of coagulation and diseases of the immune system. Also, metabolic diseases related to bone resorption such as uncontrolled diabetics or osteoporosis will be also excluded
  • History of para-functional habits (Bruxism, clenching), smoking and alcoholism.
  • History of radiation therapy in the head and neck region.

Treatment and study plan

PEEK framework

Device

All-on-4 implants with PEEK framework of fixed detachable prosthesis

Primary outcomes

  1. evaluation of changes in the peri-implant soft tissue health

    Time frame: six months

    Peri-implant soft tissue changes regarding plaque scores were assessed using the modified plaque index

  2. evaluation of changes in the peri-implant soft tissue health

    Time frame: six months

    Peri-implant soft tissue changes regarding bleeding scores were assessed using the bleeding index.

  3. evaluation of changes in the peri-implant soft tissue health

    Time frame: six months

    Peri-implant soft tissue changes regarding the gingival scores were assessed using the simplified gingival index.

Secondary outcomes

  1. Ridge base relation monitoring

    Time frame: 3 years

    periodic monitoring of the changes in the alveolar ridge height in millimeters using CBCT

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

Evaluation of Polyetheretherketone (PEEK) Framework Inserted in Multiunit Abutments of All-on-4 Concept for the Mandibular Edentulous Arch.

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Aug 30, 2023
Registry last updated
Aug 30, 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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