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

Sponsor
Mansoura University (Other)
Overall Status
Completed
CT.gov ID
NCT06017596
Collaborator
(none)
16
Enrollment
1
Location
1
Arm
24.8
Actual Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: PEEK framework
 N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
16 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Evaluation of Polyetheretherketone (PEEK) Framework Inserted in Multiunit Abutments of All-on-4 Concept for the Mandibular Edentulous Arch.
Actual Study Start Date :
Feb 23, 2021
Actual Primary Completion Date :
Feb 12, 2023
Actual Study Completion Date :
Mar 20, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: PEEK group

Patients received PEEK framework prosthesis

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

Outcome Measures

Primary Outcome Measures

  1. evaluation of changes in the peri-implant soft tissue health [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 [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 [six months]

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

Secondary Outcome Measures

  1. Ridge base relation monitoring [3 years]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Khloud Ezzat Mansoura Egypt 54790

Sponsors and Collaborators

  • Mansoura University

Investigators

  • Principal Investigator: Khloud Ezzat, PhD, Lecturer of Prosthodontics

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mansoura University
ClinicalTrials.gov Identifier:
NCT06017596
Other Study ID Numbers:
  • A17100221
First Posted:
Aug 30, 2023
Last Update Posted:
Aug 30, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Mansoura University
All-on-Four implant
CAD-CAM
PEEK framework

Study Results

No Results Posted as of Aug 30, 2023