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

NCT06017596 | Completed

• 1 other identifier: A17100221
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Bone Loss

Keywords

All-on-Four implant; CAD-CAM; PEEK framework

Outcome Measures

Primary Outcomes (3)

• evaluation of changes in the peri-implant soft tissue health

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

  six months

• evaluation of changes in the peri-implant soft tissue health

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

  six months

• evaluation of changes in the peri-implant soft tissue health

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

  six months

Secondary Outcomes (1)

• Ridge base relation monitoring

  3 years

Study Arms (1)

PEEK group

EXPERIMENTAL

Patients received PEEK framework prosthesis

Device: PEEK framework

Interventions

PEEK framework DEVICE

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

PEEK group

Eligibility Criteria

• Age: 60 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Khloud Ezzat

Al Mansurah, 54790, Egypt

Location

MeSH Terms

Conditions

Bone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Khloud Ezzat, PhD

  Lecturer of Prosthodontics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2023
• First Posted: August 30, 2023
• Study Start: February 23, 2021
• Primary Completion: February 12, 2023
• Study Completion: March 20, 2023
• Last Updated: August 30, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)